Are Baseline Factors Associated With Persistent Pain in People With Femoral Acetabular Impingement Syndrome After a Physiotherapy-led Rehabilitation Programme?
Conditions: Femoral Acetabular Impingement
Sponsor: University of Oxford

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Protocol and SAP 
 
 
“Are baseline factors associated with 
persistent pain in people with Femoral 
Acetabular Impingement Syndrome after a 
physiotherapy-led rehabilitation 
programme?” 
 
 
 
Document date 8th January 2026 

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FAIR  
Study: Femoral-Acetabular Impingement Rehabilitation Outcomes  
 
Study Title:  Are baseline factors associated with persistent pain in people with Femoral 
Acetabular Impingement Syndrome after a physiotherapy-led rehabilitation programme? 
  
Internal Reference Number / Short title: Do patient characteristics associate with poor outcomes who 
have FAIS? 
Ethics Ref: 25/YH/0258 
IRAS Project ID:358680 
Date and Version No: Version 2.0_SW8January2026 
 
Chief Investigator:
Mr Simon Wood (NDORMS
Investigators: 
Professor Karen Barker(NDORMS))
Professor Steve Gwilym (NDORMS) 
Professor Siôn Glyn Jones (NDORMS) 
Dr Victoria Harris (NDORMS) 
Professor Katja Weich (NDCN) 
 
Sponsor: 
University of Oxford 
Research Governance, Ethics and Assurance 
Joint Research Office 
Boundary Brook House 
Churchill Drive 
Headington 
Oxford OX3 7GB 

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Funder:
National Institute of Health Research
Chief Investigator Signature:
 
 
Statistician Signature:  Dr Victoria Harris 
 
There are no actual or potential conflicts of interest. 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, HRA, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so. 
 

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Study Title:  Are baseline factors associated with persistent pain in people with Femoral Acetabular 
Impingement Syndrome after a physiotherapy-led rehabilitation programme? 
Protocol Date and Version No: 2.0_SW8January2026 
 
Protocol signature page 
The undersigned has read and understood the trial protocol detailed above and agrees to conduct the 
trial in compliance with the protocol.   
 
Simon Wood 
 
 
Nufffield Orthopaedic 
Centre 
 
 
15th January 2026
Principal Investigator 
(Please print name)  
Signature 
 
Site name or ID number  
 
Date 
 
 
 
Following any amendments to the protocol, this page must be updated with the new protocol version number and 
date and re-signed by the site PI. 
 
 
 

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TABLE OF CONTENTS 
 
1. 
KEY CONTACTS ................................................................................................................................... 8 
2. 
LAY SUMMARY................................................................................................................................... 9 
3. 
ABBREVIATIONS ............................................................................................................................... 12 
4. 
BACKGROUND AND RATIONALE ...................................................................................................... 13 
5. 
OBJECTIVES AND OUTCOME MEASURES ......................................................................................... 15 
6. 
STUDY DESIGN ................................................................................................................................. 17 
7. 
PARTICIPANT IDENTIFICATION ........................................................................................................ 20 
7.1. 
Study Participants .................................................................................................................... 20 
7.2. 
Inclusion Criteria ...................................................................................................................... 20 
7.3. 
Exclusion Criteria ..................................................................................................................... 21 
8. 
PROTOCOL PROCEDURES ................................................................................................................ 21 
8.1. 
Recruitment ............................................................................................................................. 21 
8.2. 
Screening and Eligibility Assessment ....................................................................................... 21 
8.3. 
Informed Consent .................................................................................................................... 23 
8.4. 
Enrolment ................................................................................................................................ 23 
8.5. 
Blinding and code-breaking ..................................................................................................... 23 
8.6. 
Description of study intervention(s), comparators and study procedures (clinical) ............... 23 
8.6.1. 
Description of study procedure(s) ..................................................................................... 23 
8.7. 
Baseline Assessments .............................................................................................................. 25 
8.8. 
Subsequent Visits .................................................................................................................... 25 
8.9. 
Sample Handling ...................................................................................................................... 26 
8.10. 
Early Discontinuation/Withdrawal of Participants .................................................................. 26 
8.11. 
Definition of End of Study ....................................................................................................... 28 
9. 
SAFETY REPORTING ......................................................................................................................... 28 
9.1. 
Definition of Serious Adverse Events ...................................................................................... 28 
Reporting Procedures for Serious Adverse Events .................................................................................. 29 
10. 
STATISTICS AND ANALYSIS ............................................................................................................... 29 
10.1. 
Statistical Analysis Plan (SAP) .................................................................................................. 29 
10.2. 
Description of the Statistical Methods .................................................................................... 31 
10.3. 
Sample Size Determination ..................................................................................................... 32 
10.4. 
Analysis populations ................................................................................................................ 32 
10.5. 
Decision points ........................................................................................................................ 32 

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10.6. 
Stopping rules .......................................................................................................................... 32 
10.7. 
The Level of Statistical Significance ......................................................................................... 33 
10.8. 
Procedure for Accounting for Missing, Unused, and Spurious Data. ...................................... 33 
10.9. 
Procedures for Reporting any Deviation(s) from the Original Statistical Plan ........................ 33 
10.10. 
Health Economics Analysis ...................................................................................................... 33 
11. 
DATA MANAGEMENT ...................................................................................................................... 33 
11.1. 
Source Data ............................................................................................................................. 35 
11.2. 
Access to Data ......................................................................................................................... 35 
11.3. 
Data Recording and Record Keeping ....................................................................................... 35 
12. 
QUALITY ASSURANCE PROCEDURES ............................................................................................... 36 
12.1. 
Risk assessment ....................................................................................................................... 36 
12.2. 
Study monitoring ..................................................................................................................... 37 
12.3. 
Study Committees ................................................................................................................... 37 
13. 
PROTOCOL DEVIATIONS .................................................................................................................. 37 
14. 
SERIOUS BREACHES ......................................................................................................................... 37 
15. 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................................... 38 
15.1. 
Declaration of Helsinki (2024) ................................................................................................. 38 
15.2. 
Guidelines for Good Clinical Practice ...................................................................................... 38 
15.3. 
Approvals ................................................................................................................................. 38 
15.4. 
Other Ethical Considerations ................................................................................................... 38 
15.5. 
Reporting ................................................................................................................................. 38 
15.6. 
Transparency in Research ........................................................................................................ 39 
15.7. 
Participant Confidentiality ....................................................................................................... 39 
15.8. 
Expenses and Benefits ............................................................................................................. 39 
16. 
FINANCE AND INSURANCE .............................................................................................................. 39 
16.1. 
Funding .................................................................................................................................... 39 
16.2. 
Insurance ................................................................................................................................. 39 
16.3. 
Contractual arrangements ...................................................................................................... 39 
17. 
PUBLICATION POLICY ....................................................................................................................... 39 
18. 
DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF INTELLECTUAL 
PROPERTY .................................................................................................................................................... 40 
19. 
ARCHIVING....................................................................................................................................... 40 
20. 
APPENDIX A:  Study design .............................................................................................................. 43 
21. 
APPENDIX B:  Flow of the particpants through the study ............................................................... 44 

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22. 
APPENDIX C:  SCHEDULE OF STUDY PROCEDURES .......................................................................... 45 
23. 
APPENDIX D:  AMENDMENT HISTORY ............................................................................................. 46 
24.        REFERENCES 
 
 
 

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1. KEY CONTACTS 
 
Chief Investigator
Simon Wood
simon.wood@ndorms.ox.ac.uk 
Sponsor
University of Oxford 
Research Governance, Ethics and Assurance 
Joint Research Office 
Boundary Brook House 
Churchill Drive 
Headington 
Oxford OX3 7GB 
Telephone: 01865 227 374 
Email:  RGEA.Sponsor@admin.ox.ac.uk  
Funder(s)
National Institute of Health Research
enquiries@nihr.ac.uk  
personal.awards@nihr.ac.uk 
 Tel 0113 532 8444 
 
 
Clinical Trials Unit
Surgical Intervention Trials Unit Nuffield Department of Orthopaedics, 
Rheumatology and Musculoskeletal Sciences                                       
Botnar Research Centre,                                                                        
University of Oxford,                                                                               
Nuffield Orthopaedic Centre,                                                                 
Windmill Road,                                                                                            
Oxford,                                                                                                            
OX3 7HE 
01865 223491 
situ@nds.ox.ac.uk  
Statistician
Dr Victoria Harris
 

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victoria.harris@ndorms.ox.ac.ukTelephone number: 01865 227374
Management 
Committees 
Professor Karen Barker (Chair)
Email: karen.barker@ndorms.ox.ac.uk 
Professor Steve Gwilym 
Steve.gwilym@ndorms.ox.ac.uk 
Professor Siôn Glyn Jones 
Sion.glyn-jones@ndorms.ox.ac.uk 
 Dr Victoria Harris 
Victoria.harris@ndorms.ox.ac.uk 
Professor Katja Wiech 
Katja.weich@ndcn.ox.ac.uk 
 
2. LAY SUMMARY  
The hip joint is a ball and socket joint where the ball inserts into the socket. The ball shape is round but 
sometimes the ball has a bony bump on it. When the ball moves in the socket, the bump can hit the edge 
of the socket causing pain in movements like squatting or kicking a ball. Repeated hitting of the bump in 
the socket can cause hip pain, damage, and arthritis. This is called hip impingement and is found in 10-
15% of young adults.  
Does Physiotherapy treatment work?  Exercises from a physiotherapist make the muscles stronger 
around the hip joint which alters the way the ball moves. This stops the bump hitting the socket and this 
can help reduce the pain. However, an experiment found only 32% of people doing exercises got better. 
So, why after strengthening the muscles are some people still in pain? Is there another source of pain?  
Other causes of pain? We know things like people’s emotions such as ‘feeling down’ can affect pain. An 
experiment I did found neuropathic pain in people with hip impingement. This pain is caused by a 
disease of the nerves that provide information about your body. This can be a cause of pain even if your 
muscles are strong. In both situations, strengthening your muscles may not be the best choice. We need 
to know more about types of pain in people with hip impingement to give better treatment.  
Aim: To look at causes of hip impingement in people before they have physiotherapy treatment, to see if 
we can find a reason why some people don’t get better after strengthening their muscles.  
What does the study involve? 
 I will review the research to see if people with hip impingement may feel for example, sad, anxious or 
scared of moving their hip, which could be a reason why some people don’t get better after doing their 
strengthening exercises. I will invite 175 adults with hip impingement who have been referred for 

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routine standard NHS physiotherapy treatment to join this study. They will have 2 research 
appointments, 45minutes for assessment involving measuring hip movement and collection of baseline 
information and the second appointment will be 30 minutes at 4 months after starting the 
Physiotherapy-led rehabilitation to collect further information. The first one before the start of their 
physiotherapy treatment, the second one will be at 4 months from starting the physiotherapy treatment. 
At both appointments they will complete special questionnaires designed to explore emotions and 
causes of pain. I will compare the results of the questionnaires which will give me more information 
about the causes of pain and how people view their pain. This will give me a better understanding why 
strengthening exercises may not be the best treatment. 
 
Study Title 
Are baseline factors associated with persistent pain in people with 
Femoral Acetabular Impingement Syndrome after a physiotherapy-
led rehabilitation programme? 
Internal ref. no. / short 
title 
Can patient characteristics associate with poor outcome in patients with 
FAIS after physiotherapy treatment? 
Study registration 
N/A non-interventional study.  A study summary will be registered on the 
HRA Research Summaries once REC approval has been given 
Sponsor  
University of Oxford 
Research Governance, Ethics and Assurance 
Joint Research Office 
Boundary Brook House 
Churchill Drive 
Headington 
Oxford OX3 7GB 
 
Funder  
National Institute of Health Research 
   
Study Design 
A multicentred cohort study 
Study Participants 
 
Patients aged between 18 to 55 with a formal diagnosis of Femoral 
Acetabular Impingement Syndrome with absence of Osteoarthritis 
(OA).  
 
Diagnosis confirmed from clinical assessment, symptoms and 
radiographical imaging (MRI and/or X-Ray and/or CT). Imaging is 
optional as part of usual care pathway. 
 
Undergoing a physiotherapy-led rehabilitation program 
 
Sample Size 
175  

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Planned Study Period 
 
Total length of study is 24 months (planned from 31st January 2026 
to 31st January 2028) 
 
Baseline data at start of physiotherapy-led rehabilitation including 
PROMS. 
 
Final data collection for PROMS at  4 months after commencing 
physiotherapy-led rehabilitation. 
 
The physiotherapy-led rehabilitation data collection point from 
baseline to follow up will be 4 months.  
 
If treatment is required beyond 4  months, no further data will be 
collected 
 
 It is up to the treating physiotherapist to determine the frequency 
and number of treatments as this study has no influence over the 
physiotherapists management. The conclusion of this study is at 4 
months after commencement of treatment. There are two 
appointments expected.  The first appointment is gathering the 
baseline measurements at the time of the hip clinic as part of 
routine care (allowing for up to 1 hour). The second appointment to 
collect the outcome measure at 4 months if the participant is  
undergoing treatment  where either the physiotherapist or research 
assistant directs the participant to the QR code to complete the 
questionnaire, or a paper copy is given to the participant (allowing 
for up to half an hour). If the participant is no longer under the care 
of physiotherapy, they will be automatically sent via email or post a 
copy of the questionnaires. It is estimated that total duration from 
recruitment to conclusion of the study is 8 months for each 
participant. 
In the Planned 
Recruitment period 
31st January 2026 to 31st January 2028 
 
Objectives 
Outcome Measures 
Timepoint(s) 
Primary 
 
To compare 
baseline and post 
treatment 
functional 
outcomes 
International Hip Outcome Score 
33 (iHOT33) 
 
Average pain over 4 weeks 
At Baseline 
 
Post treatment 
Secondary 
 
To measure 
baseline 
characteristics prior 
to starting a PLR 
 NPSI Questionnaire 
DN4-Interview Questionnaire 
 Widespread pain index  
 Tampa scale of Kinesiophobia  
 Hospital Anxiety and Depression 
scale (HADS).  
 Pain Catastrophising Scale (PCS) 
 Average pain over 4 weeks 
 
Credibility/Expectancy 
Questionnaire (CEQ 
 
Treatment Expectation 
Questionnaire (TEX-Q) 
 
At Baseline  
 

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 
Hip range of movement 
 
Intervention(s) 
This is a non-interventional study and is purely observational. The treatment 
is routine, pragmatically applied usual standard of care physiotherapy-led 
rehabilitation program. The treatment will be based on the clinical 
assessment and reasoning of the treating physiotherapist.  This study will 
not affect or influence the PLR. 
Comparator 
No comparator  
 
3. ABBREVIATIONS 
Define all unusual or ‘technical’ terms related to the project.  Maintain alphabetical order for ease of 
reference. 
AE 
Adverse event 
Alpha angle 
Measure of sphericity of the femoral head 
BMI  
Body mass index 
CI 
Chief Investigator 
CEQ 
Credibility/Expectancy questionnaire 
CRF 
Case Report Form 
CT 
Computerised Tomography 
CTRG 
Clinical Trials & Research Governance, University of Oxford 
DN4 
Douleur Neuopathique 4 
FABER 
Flexion Abduction External Rotation (Hip impingement test) 
FADIR 
Flexion Adduction Internal Rotation (Hip impingement test) 
FAIS 
Femoral acetabular impingement 
FAIT 
Femora Acetabular Impingement Trial 
FASHIoN 
Hip arthroscopy versus best conservative care for the treatment of femoroacetabular 
impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial 
FSC 
Fibromyalgia survey criteria 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
HADS 
Hospital Anxiety and Depression scale 
HRA 
Health Research Authority 
IASP 
International Association of the Study of Pain 
ICF 
Informed Consent Form 
iHOT33 
International hip outcome score 33 

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IMD 
Index of multiple Deprivation 
Kellgren-
Lawrence 
Staging system of classification of OA graded from 0: no X-Ray findings to 4:  large 
osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of 
bone ends. 
MRI/A 
Magnetic Resonance Imaging/Arthrogram 
NeP 
Neuropathic pain 
NPSI 
Neuropathic Pain Symptom inventory 
NHS 
National Health Service 
NIHR 
National Institute of Health Research 
OA 
Osteoarthritis 
PCS 
Pain catastrophising scale 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
PLR 
Physiotherapy-led rehabilitation e.g. routine physiotherapy treatment 
PROMS 
Patient reported outcome measure e.g. validated questionnaires and pain scores measuring 
treatment outcomes 
QoL 
Quality of Life 
QR (code) 
Quick Response code 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
REDCap 
Secure web-based data collection platform 
RES 
Research Ethics Service 
ROM 
Range Of Movement (of a joint measured in degrees) 
SAE 
Serious adverse event 
SOP 
Standard Operating Procedure 
STROBE 
Strengthening the Reporting off Observational Studies in Epidemiology. 
TEX-Q 
Treatment Expectation Questionnaire 
TSK11 
Tampa scale on kinesiophobia 11 
VAS 
Visual analogue scale (0= no pain to 10, worst pain imaginable) 
WPI 
Widespread pain index 
 
 
4. BACKGROUND AND RATIONALE 
What is the problem being addressed?  

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Femoral acetabular impingement syndrome (FAIS) is characterised by abnormal morphology of the 
proximal femur (Cam) and/or the acetabulum (Pincer) resulting in premature contact between the 
femoral head or neck and the acetabulum during hip flexion and internal rotation. This repeated 
microtrauma causes progressive joint degeneration, culminating in hip osteoarthritis (OA). It is a 
common cause of hip pain in young adults, occurring in 10-15% of the population and is associated with 
impaired quality of life (QoL) [1] and disability[2]. The associated financial burden affects both the 
individual, the NHS and the wider economy as pain and disability frequently impact on the individual’s 
ability to work. Current recommended first line management of FAIS is physiotherapy-led rehabilitation 
(PLR), aiming to strengthen the muscles around the hip correcting abnormal movement patterns. 
Physiotherapy treatment regimens may include a combination of activity modification, education, hip 
muscles strengthening, joint mobilisation and soft tissue mobilisations [3-5]. If this is unsuccessful, then 
surgery should be considered to correct abnormal morphology [6]. PLR has been shown to be associated 
with statistically significant improvements in both pain and function and to be more effective at 
producing these improvements than intra-articular steroid injection [7]. However, two recently 
completed, well powered UK multicentre RCTs have compared surgery and PLR directly, rather than only 
assessing the efficacy of surgery in those who have failed physiotherapy [8, 9]. Both found surgery to be 
the most effective treatment, and this is also in line with the findings of a recent systematic review 
analysing the results of 6 RCTs comparing surgery to conservative therapy (1187 patients, 598 in 
conservative therapy arm and 589 in the arthroscopic arm) [10]. Specifically, in the Femoral Acetabular 
Impingement Trial (FAIT), Palmer et al. [8] showed that after 8 months follow-up of those participants 
receiving PLR (n=88) 68% did not achieve a minimal clinically important difference (MCID) in the Hip 
Outcome Score, (a validated patient reported outcome measure for arthroscopic hip procedures) 
compared to 49% with surgery (n=100). Whilst in the FASHIoN Trial, Griffin et al.,[9], using the iHOT-33 
score (a validated hip quality of life (QoL) questionnaire) found a mean adjusted difference of 6·8 points 
in favour of hip arthroscopy at 12 months. Importantly, however, PLR is time consuming for the 
individual but is a low-risk and low-cost treatment whilst surgery is associated with significant risk and 
markedly higher cost. The FASHIoN Trial [9] (undertaken in 23 centres across the UK) reported adverse 
events in 73% of the surgery arm and 60% of the physiotherapy arm, where serious adverse events were 
much more common in the surgery arm (6 vs 1 respectively). The adverse event in the PLR group was not 
related to treatment. Moreover, a cost utility analysis for the FASHIoN trial calculated the mean 
incremental cost for FAI surgery ranged from £2047 to £5628 and concluded that this was not cost 
effective compared to physiotherapy [11]. There is therefore an urgent need to determine which 
patients are not likely to benefit from physiotherapy for FAIS, in order to rationalise allocation of surgery. 
The pain construct for FAIS is traditionally understood to be nociceptive, arising from the damaged hip 
joint itself. The International Association of the Study of Pain (IASP) defines nociceptive pain as ‘pain that 
arises from actual or threatened damage to non-neural tissue and is due to the activation of nociceptors’ 
(sensory neurons that respond to damaging or potentially damaging stimuli). Current treatment 
modalities aim to modify these nociceptive pain drivers. However, it is well established that other types 
of pain exist and the presence of these pain mechanisms in subgroups of patients with FAIS could be a 
plausible explanation for the limited response to standard treatments. In support of this hypothesis, it is 
recognised that morphological appearances of the hip do not correlate with pain intensity [12, 13]. 
Neuropathic pain (NeP) is defined by IASP as ‘pain caused by a lesion or disease of the somatosensory 
system’ and there is increasing awareness that a neuropathic component occurs in many conditions 
traditionally considered nociceptive including OA hip/knee, ankylosing spondylopathies and 
tendinopathies [14]. NeP is characterised by abnormal pain qualities: burning, tingling or prickling; 

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mechanical and thermal hyperalgesia and often radiation to other areas. Griffin et al., consensus paper 
on FAIS [15] highlights the wide variation in clinical characteristics of FAIS pain. The secondary analyses 
of the FAIT trial undertaken during my NIHR pre-doctoral clinical academic fellowship (Wood et al)., [16] 
showed that 12% of the patients included in this trial had neuropathic pain (NeP) and 19% had mixed-
neuropathic component identified by the PainDETECT questionnaire (PDQ). Moreover, those identified 
as having NeP reported higher levels of anxiety, average pain over 4 week, and poorer hip function. This 
agrees with findings in a variety of other conditions including Osteoarthritis[17] and endometriosis [18]. 
Unfortunately, the FAIT trial was not geared towards investigating other pain phenotypes or 
characteristics and therefore lacked the measures to explore these. Further investigation of other 
mechanistic causes for pain and characteristics may explain why traditional PLR which focuses on the 
nociceptive pain driver may have limited effect. If relevant pain phenotypes and patient characteristics 
can be identified at initial presentation to physiotherapy, then a personalised treatment regime 
addressing the drivers of pain could be developed, potentially improving the outcome of PLR and 
reducing referrals for surgery.  
Rationale for the study: Primarily this study aims to explore the baseline characteristics in patients prior 
to starting a routine standard care NHS provided PLR to see if these characteristics affect the treatment 
outcome after PLR. The aim is to ultimately improve the outcomes of a PLR by providing in the future, a 
PLR treatment program tailored to the individual patient.   
How will this be done: Firstly, we will recruit patients who are aged between 18 and 55 who have a 
formal diagnosis of FAIS and fulfil the inclusion/exclusion criteria and have been referred to a PLR.  We 
aim to gather psychometric information in the form of validated questionnaires in the form of Patient 
Reported Outcome Measures (PROMS) to determine the baseline characteristics of patients presenting 
at the beginning a PLR program and gather further information by measuring hip range of movement for 
each participant. 
We will then collect psychometric information at the conclusion of the PLR program and analyse the data 
to see if baseline characteristics associate with poor outcome. 
This is an observational cohort study with no perceived risk to patients or the physiotherapist. 
Physiotherapy-led rehabilitation has been proven to be a low-risk treatment, and the intervention will be 
routine standard of care. 
 
5. OBJECTIVES AND OUTCOME MEASURES 
 
 
Objectives
Outcome Measures 
Timepoint(s) 
of 
evaluation of this 
outcome measure 
(if applicable) 

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Primary Objective
To compare baseline with post 
treatment functional outcomes 
 
 
 
Primary outcome measure
Quality of life measurement: 
international Hip Outcome Score 33 
(iHOT33). 
The iHOT 33 is a validated patient-
derived, patient reported Quality of Life 
outcome measure for non-arthritic hip 
pain. The iHOT33 consists of four 
domains: symptoms and functional 
limitations; sports and recreational, 
activities; job-related concerns and social, 
emotional and lifestyle concerns [15]  
The iHOT33 provides a 100-point score 
with 100 representing no pain and 
perfect function, and a lower scores 
indicating pain and poorer function. The 
iHOT33 has a minimal clinically important 
difference of 6.1 points [19] 
The iHOT33 is a preferred self-reported 
outcome measures to assess hip-related 
pain and function in young and middle-
aged patients.[15] 
Average Pain intensity over 4 weeks            
Visual Analogue Scale 
 
At baseline and at 4
months 
 
 
 
 
 
 
 
 
 
 
 
Secondary Objectives
 
To measure baseline characteristics 
prior to starting a PLR  
These questionnaires are designed 
to collect data on pain phenotypes, 
e.g., neuropathic pain, distribution 
of pain, fear of movement, 
emotional components and 
thoughts and perception of feeling 
pain 
Secondary outcome measures
Data collected at the start of the PLR and 
at conclusion of the study) 
Pain Phenotyping: 
Neuropathic Pain Symptom Inventory 
(NSPI)[20] 
Douleur Neuropathique 4 (DN4)[21] 
Widespread pain index (WPI)[22] 
Psychometric measurements: 
At 
Baseline
(all 
questionnaires) 
 
A cap of up to 4 
months has been 
chosen 
for 
two 
reasons: Firstly, this 
reflects 
routine 
standard care in a 
physiotherapy 
department 
and 
secondly there is a 

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Tampa scale of Kinesiophobia (TSK-11) 
[23] 
 Hospital Anxiety and Depression scale 
(HADS)[24]  
 Pain Catastrophising Scale (PCS)[25] 
 
 
Credibility/Expectancy 
Questionnaire [26] 
 
Treatment 
Expectation 
Questionnaire [27] 
Quality of life: 
iHOT33 [15] 
Average Pain intensity over 4 weeks            
Visual Analogue Scale 
 
Hip range of movement 
time limit for this 
study. 
 
At conclusion of PLR
 
Baseline+ 
Conclusion of PLR 
(up to 4 months) 
Baseline hip range 
of movement 
 
6. STUDY DESIGN 
Title:  Are baseline factors associated with persistent pain in people with Femoral Acetabular 
Impingement Syndrome after a physiotherapy-led rehabilitation programme? 
The study design is shown in Figure 1 (Appendix A) which summarises the study. 
Patients will be invited to participate in this observational prospective cohort study. 
Setting: Participants will be screened from 4 tertiary hospital sites recognised for the management and 
treatment for FAIS, allowing for a broad range of demographics. The hospital locations were chosen to 
cover a diverse population ranging from urban to rural locations and offering a broad range of 
backgrounds and culture according to the ONS Census of Population. Four centres have been selected 
from existing clinical and research networks and are expected to comprise in principle: Birmingham: 
Royal Orthopaedic Centre, Leeds: Chapel Allerton Orthopaedic Centre, Oxford: Nuffield Orthopaedic 
Centre and Exeter: Royal Devon University Hospital. Across hospital involvement will reduce spectrum 
and selection bias. All participants will be approached prior to attending their PLR with a diagnosis of 
FAIS at the specialist orthopaedic hip clinics. However, alternative centres are available should the 
situation change at any of these between application and study onset.  

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Participants: will be recruited from relevant hip clinics and from the hospital that they are attending data 
bases They will be approached by a research assistant including a study information pack after identified 
by a clinician. Participants who have a formal diagnosis of FAIS by an orthopaedic doctor/registrars or 
physiotherapists will be screened for eligibility.  
Consent: Patients with mental capacity who have a proven understanding of the English language will be 
approached. The consent form, questionnaires and information pack will be accessible on-line via a QR 
code linked to a free secure web-based data collection platform (REDCap). An information pack including 
a letter of invitation, Patient Information Sheet explaining the nature of the study and an informed 
consent form will be included in paper form. If participants would prefer, a printed copy of the 
questionnaires will be issued, and the results manually inputted.  
 
Outcome measures: Baseline physical hip characteristics will be collected from MRI or Xray 
findings: Cam size (alpha angle), OA (Kellgren Lawrence staging of OA), and radiological co-
morbidities on MRI (e.g., gluteal tendinopathy) Pain Phenotyping   Douleur Neuropathique 
4 [20] Widespread Pain Index (35) Neuropathic Pain Symptom Inventory Psychometric 
measurements  Tampa scale of Kinesiophobia (TSK-11)(36)  Hospital Anxiety and 
Depression scale (HADS)(37)  Pain Catastrophising Scale (PCS) (38) Credibility/Expectancy 
Questionnaire[26] Treatment Expectation Questionnaire [27] Quality of Life  International 
Hip Outcome Tool (iHOT33).  Visual analogue scale for pain (39), Hip range of movement 
 Two additional outcome measures in the form of questionnaires (CEQ and TEX-Q) have been included 
based on feedback from the PPIE group. For participants unable to access the QR code, a paper copy of 
the questionnaires will be provided with a self-addressed stamped envelope.  
Data collection: Baseline data will be collected and include patients mobile number, postal code, 
landline number and email address, cross checked with the patient to confirm correct contact details. 
Participants demographics: age, sex, ethnicity, weight, height, BMI, duration of symptoms, smoking 
history, laterality of the hip pain, level of education, marital and social status, work status, medication, 
patient expectations of PLR, hospital location and comorbidity data. Alpha angles calculated by 
consultant radiologists and other features from the MRI e.g. gluteal tendinopathy (to document potential 
confounders) and other characteristics identified from the systematic review. The results of the patient 
reported questionnaires will be collated and anonymised and recorded electronically.  
Sample size calculations: I have based the sample size calculations on the primary purposes of the data 
analyses exploring the strength of the relationships between variables. I plan for 9 variables identified 
from the questionnaires and ongoing systematic review where the number of participants required per 
variable for a multivariable linear regression model is 10-15. Allowing for 15 participants per variable and 
a 30% attrition rate lost to follow up, an a priori power analysis indicated that a minimum sample size of 
175 patients would provide 80% statistical power with an alpha set at 0.05 based on the primary 
purposes of the data analyses. Power calculations will be crossed checked with a statistician. 
Statistical analyses:  
I will undertake descriptive analysis of the data and will document counts, means, standard deviations or 
medians and interquartile ranges where appropriate. A Multiple Regression analyses will be performed 

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exploring the association of the baseline variables and Correlational statistics will be used to explore the 
relationships between the variables.  
Data management: All data will be recorded on REDCap which is a secure web-based data collection 
platform. Clinical data will be stored separately from patient identifying data. All data will be password 
and firewall protected. All paper records will be kept in a secured locked room in locked filing cabinets 
used to store patient data at the Physiotherapy Research Unit (Nuffield Orthopaedic Centre).  
Participants will be issued appropriate questionnaires after 4 months from commencement of their PLR 
program. This will be done via either paper copy of the questionnaires or via a QR code that is linked to 
REDcap secured database or emailed automatically by REDcap. 
Aim and objective. To identify whether pain phenotypes, psychological, social and demographics 
associate with poor outcomes after a PLR programme as defined by ongoing pain and/or hip stiffness 
and limited range of hip movement.  
The questionnaires along with patient characteristics identified from the systematic review will be 
collected to determine if there is an association between the variables and poor outcome.  
Recruitment and retention strategy. Clinical staff will be notified of the study via presentations in 
governance meetings, posters in clinic rooms and waiting areas and emails and a clear effective line of 
communication will be available for clinical staff to contact me. The posters are aimed to recruit the 
patients but will remind clinicians of the study. Regular visits are planned for the 4 sites to ensure a close 
working relationship with clinical staff and to monitor the recruitment process is on target and address 
any issues. Ongoing communication with the Patient and Public Involvement Engagement group to 
discuss strategies they identify which could be implemented to assist in recruitment and retention. 
Furthermore, strategies will be used for recruitment and retention using methods identified [28] by 
including: 
  Information on nature of the study, participants requirements detailing potential benefits and follow 
up.  
 Create project identity and logo on all study correspondence.  
 Contact and scheduling methods.  
 Non-financial incentives including a letter of appreciation.  
 Providing reminders to complete the questionnaires and self-stamped addressed envelopes for return 
of post.  
 Obtaining multiple contacts for each participant 
Data collection time points from baseline to 4 months): Prior to starting PLR, the research assistant will 
measure hip range of movement (flexion, extension, abduction, adduction, internal rotation and external 
rotation, and two impingement tests (FADIRS/FABERS).  The participant will be given the study 
Questionnaires: iHOT33 (Health related QoL) and Visual Analogue Scale (VAS) for pain intensity, TSK, 
WPI, HADS, PCS, DN4, NPSI, CEQ and TEX-Q.  

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At 4 months after commencement of treatment the participant will be given the iHOT33 questionnaire 
and pain intensity score (VAS).  No other measurements will be taken. 
A standard routine physiotherapy-led rehabilitation and follow up (PLR) provides routine care that is 
provided in an NHS setting. A personalised hip therapy programme including (i) an individualised and 
progressive exercise program, (ii) education and its management, and (iii) advice regarding pain relief 
and avoiding positions of discomfort and activity are key features to the intervention, individualisation, 
progression and supervision. A treatment log will be kept documenting clinical treatment type, 
progression and exercise prescription with sets and repetitions. Fidelity will be checked by randomly 
selecting 10 sets of Physiotherapy notes to ensure routine standard care physiotherapy as detailed 
above is adhered to. Four months will mark the duration of the study from commencement of PLR to 
follow up irrespective whether the participant is still undergoing PLR. At the beginning of PLR the 
patient’s pain, function and hip range of movement will be documented.  
At 4 months, the physiotherapist will direct the patient to the QR code (or a paper copy if required) to 
complete the questionnaires if still undergoing PLR or REDcap will automatically email the questionnaires 
if the participant has finished their PLR. Working closely with the PPIE group will ascertain preferred 
methods of filling out the questionnaires whether electronically or paper format and to advise on 
retention strategies. It is planned that non responders will be contacted via a follow-up telephone call 
and letter and email if data is still missing but this will be reviewed on feedback from the PPIE group.  
After three attempts contacting the participant, no further attempt will be used to contact the 
participant.  Paper copies of the questionnaire will be posted with a self-addressed stamped envelope if 
requested by the participant.  
 
Flowchart of the participant through the study and for the project are in Figure 2 (Appendix B) 
7. PARTICIPANT IDENTIFICATION 
 
7.1. Study Participants 
Adult male or female participants with a formal diagnosis of FAIS who meet the inclusion criteria. 
7.2. Inclusion Criteria 
Inclusion criteria include: 
 
Participants aged between 18 and 55 years 
 
Diagnosis of symptomatic FAIS following a formal clinical assessment  
 
Appropriate imaging: MRI/Arthrogram, and /or Xray and/or CT (secondary care pathway for 
diagnosis but this is optional). 
 
Awaiting PLR  
 
No previous surgery to the index hip  
 
Have capacity to give informed consent 
 
English as a spoken language 

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7.3. Exclusion Criteria 
The participant may not enter the study if ANY of the following apply:  
 
Presence of hip dysplasia, femoral stress fracture, synovitis or other inflammatory 
arthropathy (psoriatic arthropathy) 
 
Kellgren‐Lawrence grading of Osteoarthritis ≥2 (to exclude moderate OA which could be 
a confounding influence on pain) 
 
Avascular necrosis of the femoral head 
 
Previous surgery to index hip 
 
Previous physiotherapy treatment to the index hip in the past 6 months 
 
Current pregnancy 
 
Perthes disease 
 
Involved in a current research study involving the hip 
8. PROTOCOL PROCEDURES  
8.1. Recruitment 
Four centres have been selected from existing clinical and research networks and are expected to 
comprise in principle: Birmingham: Royal Orthopaedic Centre, Leeds: Chapel Allerton Orthopaedic 
Centre, Oxford: Nuffield Orthopaedic Centre and Exeter: Royal Devon University Hospital. The hospital 
locations were chosen to cover a diverse population ranging from urban to rural locations and offering a 
broad range of backgrounds and culture according to the ONS Census of Population. These centres have 
been identified as tertiary referral centres for management of hip conditions. 
Patients will be identified when attending hip clinics at their participating hospital. Following a clinical 
assessment by the clinician (Consultants, Registrars in Orthopaedics or Sports and Exercise Medicine or 
advanced practitioner physiotherapist working in the hip clinic) and appropriate imaging/referral for 
imaging and formal diagnosis of FAIS, patients will be introduced to the study by the assessing clinician. 
The initial sites for this study are the 4 sites mentioned above. The Orthopaedic and Sports and Exercise 
Medicine team will be informed of the study by formal meetings and posters in clinic rooms to remind 
them of the study and to identify potential participants. 
If the patient expresses an interest in the study, they will be introduced to a research assistant. The 
research assistant will provide an information pack with a QR code to scan which will provide more 
details of the study.  A paper information pack will be given upon request.   If the patient agrees to 
register for the study and participate, then the research assistant will use a clinic room and collect 
baseline data and consent the patient to the study. Clinicians will not be asked to obtain consent due to 
the nature of the busy clinics. 
8.2. Screening and Eligibility Assessment 
Screening for participants will principally take place in the hip clinics. These clinics are undertaken by 
orthopaedic consultants and registrars or advanced physiotherapy practitioners.  Typically, these 
patients will have been referred via their GP if previous conservative treatment has been ineffective. The 
participant will, upon agreeing to participate in the study, be screened by a research assistant using a 

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checklist for the inclusion and exclusion criteria.  If the criteria for inclusion into the study is met, and the 
exclusion criteria cleared, the research assistant will gain written consent and collect patient 
demographics including age, gender at birth, height, weight, BMI calculation, smoker, employment 
status, postcode, duration of hip pain and educational status.  The participant information pack has a QR 
code, which will direct the participant to the PROMS and provide further information on the study. The 
patients will also be screened to determine if they have had appropriate imaging in respect of MRI 
and/or Xray/and or CT as part of their pathway of care.   
This study does not include a referral for imaging as a part of the inclusion criteria. It is presumed that 
imaging will form part of a routine clinical pathway whilst attending a specialist hip clinic.  However, in 
the unlikely event of seeing any concerning structural abnormalities on a scan, the scan will be checked 
by a clinical specialist i.e., a radiologist.  If the specialist feels that the abnormality was medically 
important, they will contact the referring doctor to discuss the implications.  This can then be discussed 
with the participant and arrange for further investigations as necessary.  Patient will not be informed 
unless the doctor considers the finding has clear implications for their current or future health.  The 
participant may be withdrawn from the study pending a diagnosis from imaging that fulfils the exclusion 
criteria for e.g. if the imaging confirms a diagnosis that meets the exclusion criteria e.g. femoral stress 
fracture. 
If a member of the research team is unavailable in the hip clinics to speak to potential participants, the 
clinical care team will obtain verbal consent and document this in the patients’ medical notes for the 
patient to be contacted by the study team by telephone and send an information pack if requested. They 
will be contacted by telephone by the study team within the following week to discuss the recruitment 
process. 
A physical examination carried out by the research assistant as part of the study on the day of 
recruitment will measure passive hip range of movement for the index and asymptomatic hip: flexion, 
abduction, internal/external rotation, extension and adduction with range and pain response 
documented. Two tests for hip impingement will be performed: Flexion, adduction internal rotation 
(FADIRS) and Flexion, abduction external rotation (FABERS) which are two tests that are specific to FAIS. 
Pain and restriction in these tests will be documented. 
The estimated time for screening, obtaining consent, including physical examination and collection of 
baseline PROMS will be between 45 minutes to 1 hour. The consent form (e-Consent), and PROMS can 
be obtained and completed at the participants convenience via the QR code (or paper copy) if they are 
unable to stay for the duration of the screening process. However, the consent process and completion 
of the PROMS will be encouraged to be completed on the day of recruitment to reduce recall bias. 
If participants agree to complete the questionnaires electronically, we will use the e-consent framework 
established on REDCap. By using the QR code the participants will be taken to the participant 
information sheet and the consent form which will be completed including initials, name, data and e-
signature as on the paper version but without the researcher’s signature. Only if the participant has 
completed and signed the e-consent will they be taken to the electronic questionnaires.  The e-consent 
will be stored in REDCap as per routine practice but will not be exported with other data. Participants will 
receive an electronic copy of their consent. 

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8.3. Informed Consent 
The participant must personally sign and date the latest approved version of the Informed Consent form 
either in an electronic form or written hard copy (if requested by the participant) before any study 
specific procedures are performed. 
Written, verbal or electronic versions of the Participant Information Sheet and Informed Consent will be 
presented to the patient, detailing no less than: the exact nature of the study; what it will involve for the 
participant; the implications and constraints of the protocol; the known side effects and any risks 
involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at 
any time for any reason without prejudice to future care, without affecting their legal rights, and with no 
obligation to give the reason for withdrawal. 
The patient will be allowed as much time as required to consider the information, and the opportunity to 
question the Investigator, their GP or other independent parties to decide whether they will participate 
in the study. Written Informed Consent in the form of paper consent will then be obtained by means of 
participant-dated signature and dated signature of the person (research assistant) who presented and 
obtained the Informed Consent. If the participant is unable to stay for the duration of the assessment, 
then an e-consent can be obtained but if the participant would prefer consent may be obtained via 
phone call. The research assistant will be suitably qualified and experienced and have been authorised to 
do so by the Chief/Principal Investigator. A copy of the signed Informed Consent will be given to the 
participant. The original signed form will be retained at the study site. E-consent forms will be stored 
electronically in the patients notes. Clinicians will not be asked to obtain consent. 
 
8.4. Enrolment 
No randomisation is required for study.  Enrolment will be registered electronically via REDCap which is a 
secure web application for building and managing online surveys and databases. Consent will be gained 
either by electronic means via a QR code or by paper format. Enrolment will be obtained by a research 
assistant with paper copies kept on-site in a secured room and electronic copies kept securely on-line via 
REDCap. 
8.5. Blinding and code-breaking  
This study does not require the participant or research assistant to be blinded 
8.6. Description of study intervention(s), comparators and study procedures (clinical) 
The participants will be referred to a PLR as part of the ‘routine standard care’ pathway following the 
diagnosis of FAIS and is not part of the study. This study is purely observational and no treatment 
intervention  or comparators. A treatment log will be kept documenting treatment type, progression and 
exercise prescription with sets and repetitions. Fidelity will be checked by randomly selecting 10 sets of 
Physiotherapy notes to ensure routine standard care physiotherapy as detailed above is adhered to. 
There is no comparator in this study design. 
8.6.1. Description of study procedure(s) 

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Physical examination: 
At the recruitment and screening process the research assistant will collect baseline demographics and 
will do a physical examination measuring the following movements via a goniometer: 
Passive hip range of movement in all planes in supine: flexion, abduction and adduction and hip internal 
and external rotation in supine with the hip at 90 degrees flexion. Hip extension will be measured in 
prone lying. 
Two hip impingement tests will be performed in supine: FABERS and FADIRS which are validated tests for 
FAIS. The pain response will be documented. 
These measurements are planned to be completed after attending the hip clinic on the same day. 
Questionnaires: 
We will use a battery of validated questionnaires to evaluate patient’s characteristics. These 
questionnaires are commonly used in research. 
Quality of life questionnaire: 
 
International Hip Outcome Score33 (iHOT33):  this is a validated hip quality of life questionnaire 
for FAIS. The iHOT33 provides a 100-point score with 100 representing no pain and perfect 
function, and a lower scores indicating pain and poorer function. The iHOT33 has a minimal 
clinically important difference of 6.1 points  
Pain Phenotyping: 
 
Neuropathic Pain Symptom Inventory (NPSI) is a self-administered validated screening tool 
designed to assess diverse symptoms of neuropathic pain. The NPSI has 5 clinical domains 
assessing superficial spontaneous pain, Deep spontaneous pain, Paroxysmal pain, Evoked Pain and 
Dysethesia/Parasthesia. Douleur Neuropathique 4 [21] is a validated questionnaire which can 
differentiate between neuropathic and non-neuropathic pain, which is self-administered, quick 
and easy to complete. It contains 7 questions with a cut off of ≥3 for assessing neuropathic pain. 
 
Hospital Anxiety and Depression scale (HADS): This is used as a screening tool in non-psychiatric 
hospital clinics. The HADS is used for multiple chronic pain conditions and has good concurrent 
validity and reliability.  There are 7 items relating to anxiety and 7 items relating to depression 
with each item scored on a 4-point Likert scale from 0 to 3 with a maximum score for depression 
and anxiety of 21 respectively [24].  
 
Widespread pain index (WPI). The WPI is a questionnaire that fulfils three conditions, Widespread 
Pain Index, Symptom Severity Score where symptoms have been present for more than 3 months, 
and lastly, the patient does not have another disorder that may explain ongoing chronic pain.  This 
measure constitutes the Fibromyalgianess Scale and can be applied to every disease [22].  
Psychometric measurements: 

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 
Pain Catastrophising Scale (PCS): is a validated questionnaire that measures how an individual 
experiences pain and includes three subsections: Ruminating, magnification and helplessness. The 
PCS was therefore developed to quantify the individuals pain experience. It is a valid and reliable 
tool with adequate to excellent internal consistency with a coefficient alpha of 0.87 to 0.93[25]  
 
 
Tampa Scale of Kinesiophobia (TSK11): is a commonly used self-reported questionnaire that 
quantifies the fear of movement or re-injury. The TSK shows a high level of internal consistency 
and demonstrated moderate construct validity.  The concurrent validity is moderate ranging from 
r =0.33 to 0.59 [29]  
 
Credibility/Expectancy Questionnaire (CEQ): A validated questionnaire which is a quick and easy-
to-administer that measures patient expectations for improvement.  The CEQ measures two 
constructs; cognitively based credibility and affectively based expectancy. The CEQ measures how 
a patient ‘thinks’ treatment will help and what they ‘feel’ the treatment will help. 
 
Treatment Expectation Questionnaire (TEX-Q): A validated multidimensional questionnaire which assess 
patients’ treatment expectations measuring the impact of different expectations across conditions and 
treatments which investigates the relative impact and predictive role of expectations for treatment 
outcomes. 
Pain intensity measurement:  
 
Visual Analogue Scale (VAS): Is a unidimensional measure of pain intensity and is a widely used 
outcome for pain in the adult population for conditions such as chronic pain, rheumatic diseases 
etc. It is measured on a 100 mm line with an anchor point at 0 mm for ‘no pain’ and 100 mm 
representing severe pain. The participant is asked to mark on the 100 mm line their current pain 
intensity. The pain score is calculated using a ruler to measure along the 100 mm line where the 
mark on the scale lies. 
Evaluation of Imaging data 
This study will include results from imaging as part of the participants routine standard care (if available), 
but imaging will not be ordered as part of the inclusion criteria.  It is presumed that any participant 
attending a secondary care hip clinic for an orthopaedic consultation will fulfil a criterion for further 
investigations in the context of X-ray, MRI/A or CT. 
8.7. Baseline Assessments 
Specified in 8.6.1 
8.8. Subsequent Visits 
 

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The participants may have  completed their PLR or may still be undergoing treatment.   The follow up 
period is 4 months  after starting the PLR irrespective of whether the participant is still undergoing PLR or 
not. This is part of usual care and not related to this study.   
It is planned that the Research assistants will follow the patient up after  4 months from commencement 
of PLR and collect the PROMS whilst in the physiotherapy department. If a research assistant is not 
available, then the physiotherapist can direct the participant to the QR code with a link to the 
questionnaires. Furthermore, REDcap can automatically email the two questionnaires if the participant is 
not present in the hospital. If the participant has finished their PLR prior to 4 months, then REDcap will 
automatically email the PROMs to the participant. If the participant is still undergoing PLR, then tthe 
PROMS will be collected either by either QR code or the participant will be given a paper copy of the 
PROMS. However, if this is not possible then the research assistant will contact the participant via 
telephone and collect the PROMS or by post or electronically via email if requested. Reminders to 
participants will be sent to attempt to gather the PROMS in a timely fashion to reduce the risk of recall 
bias and prevent non-responder and lost-to-follow-up bias.  
Clinical measurements will be taken from the individual treating physiotherapist notes at the final 
treatment session in the format of hip range of movement and impingement test. In the event of missing 
data from the questionnaires, the participant will be contacted by the research assistant. Missing 
information from the questionnaire can be gathered from a telephone consultation.   
Treatment compliance will be gathered from the physiotherapist’s notes, noting how many missed 
appointments (did not attend, DNA, or unable to attend, UTA) and the number of visits and compliance 
of the rehabilitation program. 
It is planned that the participant will attend as part of their usual care two hospital visits. The first visit 
will be in the hip clinic where baseline measures will be taken.  The second visit  at 4 months will collect 
information from the two questionnaires. If the participant is no longer under the care of the 
physiotherapist, then REDcap will automatically send out the questionnaires. The visits to hospital will 
be part of the usual care for the participant i.e. attending their hip clinic appointment and their PLR 
appointment. 
 
8.9. Sample Handling  
No samples will be obtained from the participants. 
 
8.10. 
Early Discontinuation/Withdrawal of Participants 
 
During the course of the study a participant may choose to withdraw early from the study at any time. 
This may happen for several reasons, including but not limited to: 
 
The occurrence of what the participant perceives as an intolerable adverse event (AE) 
 
Inability to comply with study procedures  

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Participant decision: 
 
Participants may choose to stop the clinical treatment and/or study assessments but may remain 
on study follow-up.  
 
Participants may also withdraw their consent, meaning that they wish to withdraw from the 
study completely. In the case of withdrawal from both clinical treatment and active follow up the 
following options for a tiered withdrawal from the study will be made implicit at the consent 
stage and be covered in the patient information sheet.  
 
According to the design of the study, participants may have the following three options for 
withdrawal. 
 
  
i. Participants may withdraw from active follow-up and further communication but 
allow the study team to continue to access their medical records and any 
relevant hospital data that is recorded as part of routine standard of care, i.e., 
Imaging, disease progression data etc.   
 
ii. Participants can withdraw from the study but permit data obtained up until the 
point of withdrawal to be retained for use in the study analysis.  No further data 
would be collected after withdrawal.  
 
iii. Participants can withdraw completely from the study and withdraw the data 
collected up until the point of withdrawal. The data already collected would not 
be used in the final study analysis. (Any limits to this type of withdrawal where, 
for example analysis of their data or samples has already been integrated into 
interim results, should be explained in the participant information sheet). 
 
In addition, the Investigator may discontinue a participant from the study treatment at any time if the 
Investigator considers it necessary for any reason including, but not limited to: 
 
Pregnancy 
 
Ineligibility (either arising during the study or retrospectively having been overlooked at screening) 
 
Significant protocol deviation 
 
Significant non-compliance with treatment regimen or study requirements 
 
Clinical decision  
 
Participants that did not attend (DNA) their treatment will be contacted to determine the reason i.e., a 
change in social circumstances, forgetting to attend the appointment or treatment has resolved the hip 
pain or worsened the symptoms. Participants will be contacted via telephone or by letter as appropriate. 
If symptoms are worse because of the PLR, then an opportunity for the patient to come back to the hip 
clinic will be offered or further contact from the PI or treating physiotherapist until the adverse event has 
resolved. In the event that a change of social circumstances or purely forgetting the appointment was a 
reason for the DNA, then a further appointment will be offered. 

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If the participant withdraws from the study, then clarification with the participant will be obtained 
whether the existing data can be used for analyses or not. 
If the participant consents for the information to be used, then the data will be included as an intention-
to-treat analyses.  Further analyses using per protocol analyses will also be performed as a sensitivity 
analysis to determine the effect of missing data. 
If the participant does not permit existing data to be used for analyses, then this will be deleted from the 
data base. 
Owing to time restrictions to this DPhil, it may not be possible to further recruit to replace the 
participant, but this will be closely monitored. 
The type of withdrawal and reason for withdrawal will be recorded in the CRF. 
 
8.11. 
Definition of End of Study 
 
The end point for this study concludes after the last recruited participant has had their last visit with the 
physiotherapist and their PROMS collected on achieving the target of 175 participants. However, this 
study will also conclude after 26 months of recruiting if the target of 175 participants fails to be reached, 
whichever comes first, and all queries have been resolved. 
9. SAFETY REPORTING  
There are no expected serious adverse events expected from completing the questionnaires or 
measuring hip range of movement which is a standard routine component of a physiotherapy 
assessment. Therefore, we will not be reporting on associated adverse events. 
Adverse Event Definitions 
9.1. Definition of Serious Adverse Events 
 
A serious adverse event is any untoward medical occurrence that: 
 
results in death 
 
is life-threatening 
 
requires inpatient hospitalisation or prolongation of existing hospitalisation 
 
results in persistent or significant disability/incapacity 
 
consists of a congenital anomaly or birth defect. 
Other ‘important medical events’ may also be considered a serious adverse event when, based upon 
appropriate medical judgement, the event may jeopardise the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed above. 

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NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the 
participant was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe. 
Reporting Procedures for Serious Adverse Events 
A serious adverse event (SAE) occurring to a participant will be reported to the REC that gave a 
favourable opinion of the study where in the opinion of the CI the event was ‘related’ (resulted from 
administration of any of the research procedures) and ‘unexpected’ in relation to that procedure. 
Reports of related and unexpected SAEs will be submitted within 15 working days of the CI becoming 
aware of the event, using the HRA report of serious adverse events form (see HRA website). 
 
10. STATISTICS AND ANALYSIS 
We will summarise the flow of participants for this study using the STROBE checklist. 
Data analyses:  We will use descriptive statistics including frequencies and percentages for discrete 
variables; and mean, standard deviation, and range for normally distributed continuous variables. Data 
will be checked for normality as describe below. Bivariate analysis involving unpaired Student’s t-test or 
analysis of variance for comparing continuous and discrete variables and Pearson correlation for 
continuous variables will be used. Data will be tested for multicollinearity and after adjusting for 
multicollinearity each independent variable will be entered into a multivariate regression analysis. The 
Index of Multiple Deprivation 2015 (IMD) will be used to form a relative rank for social deprivation  
10.1. 
Statistical Analysis Plan (SAP) 
The statistical aspects of the study are summarised here with details fully described in a statistical 
analysis plan that will be available from the time that the first participant is recruited. The SAP will be 
finalised before any analysis takes place.  
 Data Description 
Demographic data will be collected by a research assistant after consent obtained. 
 Baseline characteristics:  
Sex, Age, Height, Weight, BMI, Hip laterality, work status, postcode, type, educational status, 
back pain, hip symptom duration, pain intensity, GP visits 
 Objective measurements:  
Pre and post treatment passive hip range of movement and questionnaires. 
o Patient reported outcome measures: International hip outcome tool 33 
(iHOT33).   

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This is a patient self-reported questionnaire measuring 4 domains of function: Symptoms and 
functional limitations, sports and recreational activities, job related concerns and social, 
emotional and lifestyle concerns. The iHOT33 uses a Visual Analogue Scale for each question in 
each domain. The scale is 0mm for ‘Extremely Difficult’ to 100mm representing ‘Not difficult at 
all’.  The iHOT33 is calculated as a mean of all VAS scores. The meaningful clinical important 
difference is the iHOT33 is 6.0 [19] A total score of 100 is no pain and full range of movement 
and no functional limitation, thus the higher the score, the better the hip function. 
o Average pain over 4 weeks. 
This is measured from the data collection sheet. This outcome is a unidimensional patient 
reported numerical pain rating scale.  The respondent selects a whole number (integers 0–10) 
that best reflects the intensity of pain, The anchors are 0 = no pain and 10 = maximum pain. 
Average pain over 4 weeks is used because this acknowledges the fluctuations of pain intensity 
over time.  The MCID for the numerical pain rating scale is a 2-point change. (Ostelo & de Vet 
2005)  
Definition of poor outcome: Patients not reaching an MCID of 6 points on the iHOT33 or MCID 
of 2 points on Average pain over 4 weeks. 
  
 
 
 
 Variable category 
 
Variable 
Category 
Sex 
Nominal 
Employment status 
Nominal 
Educational status 
Nominal 
Hip Laterality 
Nominal 
Back pain 
Nominal 
Postcode 
Nominal 
Back pain duration (years) 
Continuous 
Hip pain duration 
Continuous 
Age (years) 
Continuous 
Height (cm) 
Continuous 
Weight (kg) 
Continuous 
BMI (kg/m2) 
Continuous 
Hip range of movement (degrees) at Baseline  
Continuous 
iHOT33 
Continuous 

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Average pain over 4 weeks (VAS) 
Continuous 
Questionnaires: TSK, HADS, PDQ, WPI, PCS, 
CEQ, TEX-Q  
Continuous 
 
 Statistical Methods 
Continuous measurements will be described using by the means and standard deviations (or 
median and interquartile range, as appropriate). Nominal and ordinal data will be described as 
counts and percentages. 
Statistical analysis 
Objective 
Parametric test 
Quantify the correlation 
baseline data with the 
outcome 
Pearson correlation 
Explore the unadjusted 
association of baseline 
factors on the outcome 
Linear regression 
 
Explore the adjusted 
association of baseline 
factors on the outcome 
Multiple (linear) regression 
Predictor 
Independent t-test 
Comparing nominal data 
with iHOT33 
Independent t-test 
One-way ANOVA 
 
Results will be reported with 95% confidence intervals, and statistical testing performed at the 
significance level of 0.05. 
 Data Management 
The FAIT database is stored on two password electronic devices. The first device is on the hard 
drive of a password NDORMS Dell computer, and the second device is a password protected 
memory stick. 
Data cleaning of the FAIT database will be completed and formatted Excel version 2503. 
STATA version 19.5 will be used to analyse the data with graphical representation and tables 
where appropriate.  
10.2. 
Description of the Statistical Methods  
Statistical analyses:  
All data sets will be tested for normality using the K-S test and Shapiro-Wilks test and the Q-Q plot will be 
visually inspected for distribution.  This will inform the decision to use non/parametric statistical tests. I 

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will undertake descriptive analysis of the data and will document counts, means, standard deviations or 
medians and interquartile ranges where appropriate. An alpha value of 0.05 will be used for hypothesis 
testing and statistical significance with 95% confidence intervals documented. A Multiple Regression 
analyses will be performed exploring the association of the baseline variables and Correlational statistics 
will be used to explore the relationships between the variables. 
 
10.3. 
Sample Size Determination  
I have based the sample size calculations on the primary purposes of the data analyses exploring the 
strength of the relationships between variables. We are planning 9 variables identified from 
questionnaires where the number of participants required per variable for a multivariable linear 
regression model is 10-15. Allowing for 15 participants per variable and a 30% attrition rate lost to follow 
up, an a priori power analysis indicated that a minimum sample size of 175 patients would provide 80% 
statistical power with an alpha set at 0.05 based on the primary purposes of the data analyses. 
 
10.4. 
Analysis populations 
All eligible participants that enrolled and registered into the study at baseline who underwent a PLR will 
be included in the study.  Participants who fail to complete the PLR program will be included into the 
statistical analyses using intention-to-treat to account for missing data. Furthermore, it is anticipated a 
per-protocol analysis will be performed to evaluate all participants that received and completed the PLR. 
 
10.5. 
Decision points  
An interim analysis will be scheduled once all baseline data has been collected.  These analyses will form 
part of the cross-sectional study and provide a description of the population. The final analyses will be 
completed at the conclusion of the study once either the last patient has completed their PLR, or the 
duration of the study has been reached, and all follow up PROMS have been collected. The reporting of 
the results will follow the STROBE statement and checklist. 
The data sets will be available to the supervisory team, myself and the supervisory team: Professors 
Karen Barker, Steve Gwilym, Sion Glyn Jones, Gary Collins and Katja Weich. Furthermore, the research 
assistants will have access to the data base to allow for data entry. Decisions based on the results of the 
study will be discussed within the supervisory team and agreed by consensus. 
10.6. 
Stopping rules 
Participant recruitment will be closely monitored.  If recruitment levels fall behind expected predicted 
numbers, then the recruitment strategy will be reviewed. This study will be registered with the Research 
Delivery Network to facilitate further recruitment centres if the recruitment levels fall behind target. 
Other sites for recruitment may become available to provide extra opportunities for recruitment. 

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However, if after consideration, that the study demonstrates futility or lack of power then the 
supervisory group will meet to discuss the future of the study, and a decision will be made.  
Futility: It is expected that treatment efficacy will not be an issue because standard routine PLR has been 
shown to be effective. 
10.7. 
The Level of Statistical Significance 
An alpha P value level of significance is set at 0.05 
10.8. 
Procedure for Accounting for Missing, Unused, and Spurious Data. 
We will perform a complete case analysis of observed data. Given the overall size of the study and the 
anticipated level of data expected to be available, no imputation of data is planned. 
 
10.9. 
Procedures for Reporting any Deviation(s) from the Original Statistical Plan 
No secondary analyses are planned 
10.10. 
Health Economics Analysis  
Not applicable 
11. DATA MANAGEMENT 
The plan for the data management of the study is outlined below. There is not a separate Data 
Management document in use for the study.  
 
Description of data
Type of study
A prospective cohort study identifying baseline characteristics that are associated with a poor 
outcome after a physiotherapy -led rehabilitation programme with patients with femoral acetabular 
impingement. 
 
There are 2 types of categorical data to be collected: 
 
Continuous: 
 
Baseline demographics and PROMS:  Age, Height, weight, BMI, hip passive range of 
movement, hip pain duration, average pain over 4 weeks, iHOT33, TSK11, pain VAS, NPSI, 
DN4, FM widespread pain index, HADS, PCS, CEQ and TEX-Q  
Nominal: 
 
Gender, work status, work type, hip laterality, postcode, level of education 
 
Imaging data (if available) 
 
MRI scans 
 

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Data collection/generation
Baseline demographics and data generated by questionnaires will be stored on REDcap.  REDcap is a 
secure online data capture system designed and developed for clinical research and hosted by the 
University of Oxford servers.  Data on REDcap will be exported onto non-propriety structured 
formats. Study data in paper form will be stored on the participating NHS hospital sites in locked 
cabinets in a secure area accessed by the research team only.  
 
All data generated will meet the FAIR Guiding Principles for scientific data management and 
stewardship.  SITU will support methodology and conduct of the study. 
 
Data quality and standards. 
Questionnaire data and consent forms will be collected on each patient and will be stored in REDCap 
allowing data capture to be standardized using a prepared database or log files. 
 
Managing, storing and curations
The electronic data will be stored in line with the Nuffield Department of Orthopaedics, 
Rheumatology and Musculoskeletal Sciences (NDORMS) information security policy. Data will be 
stored at the University of Oxford on secure fileservers managed by Medical Sciences Division (MSD) 
IT Services, following the MSD IT Services security policy, which is compliant with the University’s 
Information Security Policy. MSD IT virtual servers are imaged daily, allowing for fast recovery to 
ensure disaster recovery and long-term storage. 
 
Data will be organised and integrated in formats that allow future retrieval and usage.  
 
Data curating will be managed by the principal investigator, following the FAIR Guiding Principles for 
scientific data management and stewardship. 
Data preservation strategy and standards. 
All data will be retained for the lifetime of the project as specified above and for three years following 
completion to allow any questions regarding publications to be answered. 
 
 
Data Sharing and access
Suitability for sharing
The data collected during this study is suitable for sharing in aggregated, de-identified form 
immediately after the research article publication. Strictly no data will be shared that could identify 
participants. 
 
Discovery by potential users of the research data 
Potential users can find out about the data from publications in journals, conference presentations. 
 
Governance of access 
The project will adhere to the NDORMS Information Security Policy which defines general rules for 
the securing access of data. The PI will be responsible for decisions on whether to supply non-
identifiable research data to potential new users 
 
The study team’s exclusive use of the data 
We expect to adopt the policy that the research team should have exclusive use of the data until the 
data is published. Aggregate, de-identified data may be shared with named collaborators during this 
time. 
 
Restrictions or delays to sharing, with planned actions to limit such restrictions 

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There will be restrictions to data sharing due to participant confidentiality. We will be able to share
anonymised data.  
 
Regulation of responsibilities of users 
Where we engage with any collaborators, and where appropriate, we reserve the right to share the 
data and analysis under Non-Disclosure Agreement. Access to study data by external users will be 
bound by a data-sharing agreement, which will address handling of intellectual property, publication, 
authorship and acknowledgement. 
 
 
Responsibilities
The CI will take overall responsibility for data management, documentation, curation, metadata 
creation, and quality assurance of data. The Medical Sciences Division IT and NDORMS IT Support 
teams will take responsibility for data security, storage, back-up and access. Information security 
advice will be provided by NDORMS Information Governance Manager. 
 
Relevant institutional, departmental or study policies on data sharing and data security
Data Management Policy and Procedures
http://researchdata.ox.ac.uk/university-of-oxford-
policy-on-the-management-of-data-supporting-
research-outputs/ 
Data Security Policy
https://www.infosec.ox.ac.uk/guidance-policy 
https://www.ndorms.ox.ac.uk/information-
security-policy 
Data Sharing Policy
https://researchdata.ox.ac.uk/home/sharing-your-
data/ 
Institutional Information Policy
http://www.admin.ox.ac.uk/dataprotection/policy/
 
11.1. 
Source Data 
Source documents are where data are first recorded, and from which participants’ CRF data are 
obtained. These include, but are not limited to, hospital records (from which medical history and 
previous and concurrent medication may be summarised into the CRF), clinical and office charts, 
laboratory and pharmacy records, diaries, microfiches, radiographs, and correspondence. 
CRF entries will be considered source data if the CRF is the site of the original recording (e.g. there is no 
other written or electronic record of data).  A QR code will be used to gather PROMS and electronically 
downloaded to REDCap as additional source data.  All CRF documents will be stored safely in confidential 
conditions and the electronic source data will be secured on the REDCap secure database. On all study-
specific documents, other than the signed consent, the participant will be referred to by the study 
participant number/code, not by name. 
11.2. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor and host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
11.3. 
Data Recording and Record Keeping 
.  

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Data collection and entry: All study data will be anonymised as soon as possible and will be entered 
directly into a secure REDCap database by the participant or a member of the study team during data 
collection. Participant identifiable data will be stored securely in accordance with SITU Standard 
Operating Procedures (SOPs).  
All trial data will be entered on paper CRFs and REDCap which is a secure web application that employs 
encryption-at-rest on mobile devices to protect the data from unauthorised access.  
The participants will be identified by a unique trial specific number and/or code in both the CRF and on 
the REDCap database.  The name and any other identifying detail will NOT be included in any trial data 
electronic file, with the exception of the electronic consent forms. 
Paper CRF will be held in a secure environment and stored in locked filing cabinet or equivalent or in an 
office which is locked or attended only by authorised staff at each participating centre.  If documents 
including paper consent forms are taken off-site this will be for shortest time possible, and with 
authorisation from the line manager. The documents will be kept securely in a document holder and not 
left unattended. 
No identifiable, personal data will be retained centrally (i.e. by the sponsoring organisation), but rather 
this will be held at individual sites only. 
After the conclusion of the study, all data will be kept for 5 years and stored on University of Oxford 
secured servers and firewall and password secured computers. In compliance with the University of 
Oxford Data Protection Checklist, with consideration to: Transparency, Data minimisation and Security. It 
is not planned for the data to be shared with other organisations outside the scope of this study but if 
required to do so, written legal agreements will be obtained. Further information can be obtained from 
the Information Governance Policies below. 
Information Governance Policy:   
https://researchsupport.admin.ox.ac.uk/policy/data/practical 
https://researchsupport.admin.ox.ac.uk/policy/data/checklist  
 Information Governance and confidentiality - Oxford University Hospitals 
Information%20Governance%20Policy/Information%20Governance%20Policy%20v9.2%20FULL.pdf 
Privacy Notice: https://www.ouh.nhs.uk/privacy/default.aspx 
 
12. QUALITY ASSURANCE PROCEDURES 
Fidelity of the PLR is planned, and 10 randomly selected physiotherapy notes will be inspected to 
ascertain if the PLR is appropriate, progressive and all data points are being recorded. 
The study may be monitored, or audited in accordance with the current approved protocol, GCP, 
relevant regulations and standard operating procedures.  
12.1. 
Risk assessment  

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A risk assessment and monitoring plan will be prepared before the study opens and will be reviewed as 
necessary over the course of the study to reflect significant changes to the protocol or outcomes of 
monitoring activities.  
12.2. 
Study monitoring  
This is a low-risk study and regular monitoring by the research team will be performed according to the 
study specific Monitoring Plan. Data will be evaluated for compliance with the protocol and accuracy in 
relation to source documents as these are defined in the study specific Monitoring Plan. Following 
written standard operating procedures, the monitors will verify that the clinical study is conducted, and 
data are generated, documented and reported in compliance with the protocol, GCP and the applicable 
regulatory requirements.  
MRI results will be accessed at part of the routine care pathway after a radiologist has formally reported 
the results. This study does not involve referring for imaging therefor the ownership of the results of the 
MRI lay with the referring clinician and radiologist. 
 
12.3. 
Study Committees  
Management committee: This study is small, logistically simple and low risk therefore the DPhil 
supervisory team will manage and oversee the study with regular meetings with ad hoc meeting as 
required.  The meetings will discuss issues of recruitment, participant retention, effective and accurate 
data gathering and fidelity of the study.  Furthermore, we will involve a member of the PPIE group to 
advise on matters arising and to ensure that information to participants is appropriate and accurate. 
Th frequency of meeting will be planned for every three monthly or more frequently if required. The 
composition of the meetings will include Professors Barker, Gwilym, Glyn Jones, Collins and Weich with 
Professor Barker as chair. 
13. PROTOCOL DEVIATIONS  
A study related deviation is a departure from the ethically approved study protocol or other study 
document or process (e.g. consent process or administration of study intervention) or from Good Clinical 
Practice (GCP) or any applicable regulatory requirements. Any deviations from the protocol will be 
documented in a protocol deviation form and filed in the study master file. SITU SOPs will be 
followed for the procedure of identifying non-compliances, escalation to the central team and 
assessment of whether a non-compliance/deviation may be a potential serious breach 
14. SERIOUS BREACHES 
A “serious breach” is a breach of the protocol or of the conditions or principles of Good Clinical Practice 
which is likely to affect to a significant degree – 
 (a) the safety or physical or mental integrity of the trial subjects; or 
(b) the scientific value of the research. 

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In the event that a serious breach is suspected the Sponsor must be contacted within 1 working day. In 
collaboration with the C.I., the serious breach will be reviewed by the Sponsor and, if appropriate, the 
Sponsor will report it to the approving REC committee and the relevant NHS host organisation within 
seven calendar days.  
15. ETHICAL AND REGULATORY CONSIDERATIONS 
15.1. 
Declaration of Helsinki (2024) 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki.  
15.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. All investigators and research assistants will be up to date with their GCP training. 
15.3. 
Approvals 
Following Sponsor approval, the protocol, informed consent form, participant information sheet and any 
proposed advertising material will be submitted to an appropriate Research Ethics Committee (REC), and 
HRA (where required) and host institutions for written approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
15.4. 
Other Ethical Considerations 
This study will only include participants who are able to understand verbal and written instructions in 
English and have capacity to fulfil the treatment regime. Participants are expected to follow written 
instructions provided by a physiotherapist for the progression of their rehabilitation independently and 
at home which forms part of the treatment regime. The nature of the questionnaires are designed to 
collect information about pain perception and effects of pain on activities of daily living. If there are 
questions that the participant finds upsetting, then they can leave the questions blank and are under no 
obligation to answer all questions. For some questions there are options to choose ‘not applicable’. 
This study does not involve ordering imaging.  If structural anomalies or pathologies are detected that 
are clinically significant, then the referring clinician is responsible for feeding back the results to the 
participant, and the appropriate medical management required, if appropriate. 
15.5. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the 
host organisation and funder (where required). In addition, an End of Study notification and final report 
will be submitted to the REC Committee, HRA, host organisation, Sponsor and funder (where required).  

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15.6. 
Transparency in Research  
This study will be registered with the HRA and a summary of the study will be published in the HRA 
Research summaries 
15.7. 
Participant Confidentiality 
The study will comply with the UK General Data Protection Regulation (GDPR) and Data Protection Act 
2018, which require data to be de-identified as soon as it is practical to do so. The processing of the 
personal data of participants will be minimised by making use of a unique participant study number only 
on all study documents and any electronic database(s), with the exception of consent forms where the 
full name will be included and where participant initials may be added.  All documents will be stored 
securely and only accessible by study staff and authorised personnel. The study staff will safeguard the 
privacy of participants’ personal data. 
15.8. 
Expenses and Benefits 
It is planned that baseline and follow up data will be obtained during hospital visits as part of routine 
care.  There will be no reimbursement for participants as it is planned that data will be gathered during 
the routine hospital visits. 
16. FINANCE AND INSURANCE 
16.1. 
Funding 
The study will be funded through an NIHR grant (HFT000240) as costed on the SoECAT  
16.2. 
Insurance 
The University has a specialist insurance policy in place which would operate in the event of any 
participant suffering harm as a result of their involvement in the research (Newline Underwriting 
Management Ltd, at Lloyd’s of London).  NHS indemnity operates in respect of the clinical treatment that 
is provided. 
16.3. 
Contractual arrangements  
Appropriate contractual arrangements will be put in place with all third parties.  
17. PUBLICATION POLICY 
The results of the study will be disseminated to the PPIE group who advised and was involved in the 
planning of the study. The Investigators and supervisory team will be involved in reviewing drafts of the 
manuscripts, abstracts, press releases and any other publications arising from the study.  Authors will 
acknowledge that the study was funded by The National Institute of Health research (NIHR).  Authorship 
will be determined in accordance with the ICMJE guidelines and other contributors will be 
acknowledged. 

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18. DEVELOPMENT OF A NEW PRODUCT/ PROCESS OR THE GENERATION OF INTELLECTUAL 
PROPERTY  
Ownership of IP generated by employees of the University vests in the University. The University 
will ensure appropriate arrangements are in place as regards any new IP arising from the trial.  
19. ARCHIVING 
After completion of the study, all essential documents will be retained for 5 years. Documents will be 
retained in a lockable filing cabinet at the Physiotherapy Research Unit at the Nuffield Orthopaedic 
Centre. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Retention 
Contacts call 
and letter. 
Screening 
participants 
Prospective longitudinal cohort 
study  
Standard clinical care
Identification of patient

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Figure 1 APPENDIX A:    Study design 
 
 
 
 
 
 
 
 
 
Abbreviations: CEQ: Credibility/Expectancy Questionnaire, DN4: Douleur Neuropathique 4, iHOT33: International Hip Outcome Score 33, 
HADS: Hospital Anxiety and Depression Scale, NPSI: Neuropathic Pain Symptom inventory, PCS: Pain Catastrophizing Scale, , PLR: 
Physiotherapy-Led Rehabilitation,: TSK11: Tampa Scale if Kinesiophobia 11, TEX-Q: Treatment Expectation Questionnaire, WPI: 
Widespread Pain Index 

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20. Figure 2 APPENDIX B:   Flow of the participant through the study 
 
 
 
 
 
 
 
 
 
 
 
…………………………………………………………………………………………………………………………………………………………………... 
 
 
 
 
…………………………………………………………………………………………………………………………………………… 
 
 
 
 
 
 
………………………………………………………………………………………………………………………………………………… 
 
 
 
Clinic 
attendance
    Recruitment and eligibility
Clinical 
diagnosis 
Invitation to the study 
During clinic
Patient 
screening 
Patients not eligible
Visit 1
Four months of standard care physiotherapy-led rehabilitation 
Visit 2
Entered in study 
Informed consent
Hip ROM measured 
PROMS
Pain VAS 
iHOT33
Participants may continue treatment at 
discretion of the physiotherapist 
Ad-hoc contact via 
telephone call  
Collection of missing 
data 
  End of study 

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21. APPENDIX C:  SCHEDULE OF STUDY PROCEDURES 
 
Procedures 
Clinic day 
Follow up 
on 
discharge 
 
Further 
assessment 
 
Screening/Baseline 
Follow up 
assessment 
Collection of 
missing data 
(either face to 
face of 
telephone) 
 
Informed consent 
 
 
 
 
Demographics 
 
 
 
 
Medical history 
 
 
 
 
Physical examination 
 
 
 
 
Eligibility assessment 
 
 
 
 
Baseline Questionnaires 
 
 
 
 
Follow up 
Questionnaires 
 
 
 
 
Adverse event 
assessments  
To monitor and arrange a follow up if necessary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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22. APPENDIX D:  AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes
Details of Changes made
1
0.2
3/2/2026
Simon Wood
Change in statistician,
Added 2 questionnaires: 
TEX-Q and CEQ as 
planned from PPIE 
feedback 
Added two pain  
questionnaires: DN4 and 
NPSI 
Removed painDETECT 
questionnaire. 
Change duration of 
follow up from 6 
treatments to 4 months 
after starting PLR 
 
List details of all protocol amendments here whenever a new version of the protocol is produced.   
Protocol amendments must be submitted to the Sponsor for approval prior to submission to the REC 
committee and HRA (where required). 
 
 
 
 
 
 
 
 
 
 
 
 
 

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© Copyright: The University of Oxford and Oxford University Hospitals NHS Foundation Trust 2019 
 
Page 46 of 47 
 
23. REFERENCES 
 
 
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2. 
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Page 47 of 47 
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