To Develop and Validate a Structured Exercise Protocol and to Assess Its Effectiveness in Patients With Sub Acromial Impingement Syndrome
Phase: NA
Conditions: Subacromial Impingement Syndrome
Sponsor: Hamad Medical Corporation

Page 1 of 39 
 
 
 
HMC RESEARCH 
PROTOCOL 
 
Study Title: 
To develop and validate a structured exercise protocol and to 
assess its effectiveness in patients with sub acromial 
impingement syndrome 
Principal 
Investigator: 
Reshma Shashank Gurav 
Physiotherapy Specialist 
Female Outpatient Department –Bin Omran 
Qatar Rehabilitation Institute 
 
Contents 
1. Synopsis ........................................................................................................................... 2 
2. Abbreviations and Acronyms ............................................................................................ 2 
3. Introduction / Background ................................................................................................. 4 
4. Objectives ......................................................................................................................... 8 
Objectives ............................................................................................................................ 8 
5. Indicate if this is a retrospective data review ..................................................................... 9 
6. Study Methodology ......................................................................................................... 10 
7. Study Population and Study Setting/ Location ................................................................ 18 
8. Study procedures ............................................................................................................ 19 
9. Study Duration and Timelines ......................................................................................... 31 
10. 
Informed Consent ........................................................................................................ 32 
11. 
Risk .............................................................................................................................. 32 
12. 
Outcomes .................................................................................................................... 32 
13. 
Data Collection, Management & Confidentiality ........................................................... 33 
14. 
Subject Withdrawal/ Withdrawal of Consent ................................................................ 33 
15. 
Statistical Consideration and Data Analysis ................................................................ 34 
16. 
Adverse Event Reporting ............................................................................................. 36 
17. 
Ethical Consideration ................................................................................................... 36 
18. 
Sponsor, Funding & Collaborator Information .............................................................. 36 
19. 
Dissemination of Results and Publication policy .......................................................... 37 
20. 
References .................................................................................................................. 37 
21. 
Appendices .................................................................................................................. 39 
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1. Synopsis 
 
Shoulder impingement syndrome (SIS) is responsible for 44% to 60% of medical 
consultations related to shoulder pain with an approximate prevalence of 70-200 per 1000 
adults, which implies a remarkable use of health care resources. The cost for society is 
high and patients with shoulder disorders account for 20% of all disability due to 
musculoskeletal disorder. The underlying mechanisms are thought to include inflammation, 
degeneration of the tendons or bursa, dysfunctional scapulothoracic and glenohumeral 
mechanics, debilitated scapular musculature, joint capsule irregularities, postural 
abnormalities of the neck and shoulder, and morphological abnormalities of the relevant 
skeletal elements. 
There is a need for well-designed structured exercise program in detail considering 
content, dosage and progression to guide treatment for patients with sub acromial pain. 
The purpose of this study is to develop and validate a structured exercise protocol and to 
assess its effectiveness in patients with sub-acromial impingement syndrome. Through the 
extensive literature review, the exercise program would be proposed. We will develop and 
evaluate a structured exercise programs for sub acromial impingement syndrome using an 
expert consensus Delphi-based survey technique. A randomized controlled trial will be 
conducted. Group A (Experimental Group) will receive structured exercises for twelve 
weeks and Group B (control group) will receive conventional exercise program for 12 
weeks. Evaluation of the participant will be done at the baseline using Constant Murley 
Score, shoulder pain and disability Index (SPADI). Shoulder range of motion, shoulder 
muscles extensibility will be assessed and scapulothoracic ratio will be calculated and 
documented. T-FAST test will be conducted to score the patients functional performance. 
Assessment will be done at baseline, 3, 6, 9, and 12 weeks in both the groups. At the end 
of the study the data will be collected, coded and tabulated using descriptive and inferential 
statistics. 
 
2. Abbreviations and Acronyms 
 
1. Shoulder impingement syndrome (SIS): The inflammation and irritation of the rotator 
cuff tendons as they pass through the sub acromial space, resulting in pain, 
weakness, and reduced range of motion within the shoulder. 
 
2. TIDieR: Template for intervention description and replication 
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3. Physiotherapeutic Exercises: - Exercise is a type of physical activity consisting of 
planned, structured, and repetitive bodily movement done to improve and/or maintain 
one or more components of physical fitness 
 
4. SPADI: The Shoulder Pain and Disability Index is a self-administered questionnaire 
that consists of two dimensions, one for pain and the other for functional activities. 
 
5. VAS: The visual analogue scale (0–10) is used to assess the patient’s perceived pain 
intensity at rest, during arm activity and at night during the previous 24 hours at each 
follow-up. 
 
6. TFast: Timed Functional Arm and Shoulder Test is a sensitive test to detect 
differences in functional performance between age groups, demonstrates adequate 
reliability, and feasibility in a symptomatic patient group 
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3. Introduction / Background 
 
Shoulder pain is the second most common problem among the general population reporting 
musculoskeletal pain. Values between 6.9 to 26% have been reported for point prevalence 
and 7 to 67% for lifetime prevalence. The pain is often of long duration and only 50% of 
patients report recovery after 18 months. Shoulder impingement syndrome (SIS) is 
responsible for 44% to 60% of medical consultations related to shoulder pain with an 
approximate prevalence of 70-200 per 1000 adults, which implies a remarkable use of health 
care resources. The cost for society is high and patients with shoulder disorders account for 
20% of all disability due to musculoskeletal disorder1. 
Many terms have been used to describe sub acromial pain and pathology, including sub 
acromial impingement syndrome, rotator cuff tendinopathy, sub acromial bursitis, 
supraspinatus tendinosis, and rotator cuff syndrome. The variety in diagnostic labels reflects 
the uncertainty regarding the pathogenesis. The most common source of pain appears to be 
the sub acromial bursa and the rotator cuff with the diagnostic label sub acromial impingement 
syndrome (SIS). SIS refers to the pain that arises when structures in the sub acromial space 
(primarily the rotator cuff tendons and the sub acromial bursa) are impinged between the 
humeral head and the acromion mainly during arm activity above the horizontal plane 2. This 
syndrome is a multifactorial condition where intrinsic and extrinsic mechanisms of rotator cuff 
pathology are the two main factors. The most common deficits are alterations in 
scapulothoracic kinematics, humeral head displacement within the glenoid cavity and 
increased elevation and retraction of the clavicle in the sternoclavicular joint during arm 
elevation. 
The underlying mechanisms are thought to include inflammation and/or degeneration of the 
tendon(s) or bursa (e), dysfunctional scapulothoracic and glenohumeral mechanics, 
debilitated scapular and/or rotator cuff musculature, joint capsule irregularities, postural 
abnormalities of the neck and/or shoulder, and morphological abnormalities of the relevant 
skeletal elements 3. Repetitive activity, particularly during overhead work, heavy lifting and 
forceful work, as well as working in an awkward posture increases the risk of shoulder 
disorders. During arm elevation, the scapula must externally rotate, upwardly torque and tilt 
posteriorly. Abnormal scapular kinematics is common in SIS and may include reduced upward 
rotation and external rotation of the scapula, along with increased elevation and retraction of 
the clavicle, although increased upward rotation of the scapula has also been noted4. 
 
Intrinsic factors affect tendon morphology and performance over time. These factors are 
influenced by genetic predisposition, age related changes, poor vascularity, biological 
alterations and mechanical properties where the physiological limit of the rotator cuff tendons 
are surpassed. 
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Extrinsic factors relate to anatomical structure and biomechanical alterations causing 
mechanical compression. Biomechanical alterations refer to the superior translation of 
humeral head and altered scapulohumeral kinematics, which is often caused by a weakness 
and imbalance of the rotator cuff musculature, and/or tendons opposing superiorly directed 
shifts as well as postural dysfunction. This can present as external impingement with 
narrowing of the sub acromial space or internal impingement within the glenohumeral joint 
space4. 
Alterations in shoulder kinematics are often observed among patients with SIS. Postural 
dysfunction relating to increased flexion and kyphosis of the thoracic spine cause alignment 
impairments which interfere with shoulder kinematics. These kinematic alterations contribute 
to narrowing of the sub acromial space (external impingement) which can affect biceps 
tendons, rotator cuff tendons, sub acromial bursa and sub tendinous bursa increasing the risk 
of joint inflammation and tears3. 
Considering all these biomechanical alterations, exercise therapy remains principal 
intervention in the management of sub acromial shoulder pain. Exercise therapy is always 
prioritized as the primary treatment. Physiotherapists often tailor rehabilitation programs to 
correct movement deficits, postural dysfunction and or muscles weakness/imbalance to 
improve characteristics of the sub acromial space. 
Conclusions from various systematic reviews suggest that physiotherapy interventions, 
combining different methods or techniques like manual therapy, electrotherapy that seems to 
be of additional benefit. Although there is evidence to suggest exercise interventions can 
reduce shoulder impingement symptoms, there is minimal evidence of these interventions 
changing movement patterns of the scapula. 
Ludewig and Braman also highlighted the need to link exercise regimes with changes in 
scapular movement patterns and regaining motor control. The scapula plays several key roles 
to optimize the function of the shoulder, providing a position of support and a motion for 
stability. Its position facilitates optimal muscle activation and strength development, and force 
and energy transfer through the kinetic chain, while its dynamic motion maximizes 
glenohumeral (G-H) concavity/compression kinematics and G-H stability, maximizes G-H 
range of motion, and minimizes humeral impingement. Studies have accurately documented 
the composite 3-dimensional scapular motions necessary to optimize the roles1. 
Numerous systematic reviews have been undertaken in relation to the various plausible 
interventions including exercise and multimodal physiotherapy but many are emphasizing on 
strengthening exercise program 5. According to the literature review, the mainstay of exercise 
program includes phase wise strength and endurance program. Whereas considering the role 
of scapulothoracic joint, motor control in initial phase of sub acromial impingement has the 
priority. Several studies have reported aberrant scapular muscle activities in patients with 
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subacromial pain. Correction of scapular alignment with respect to scapulothoracic and 
glenohumeral mechanism with diagnosing the cause and identifying the source or affected 
structure is of utmost importance 6. 
 
Need of the Study 
Recent systematic review and meta-analysis conducted by Louis Pieter and Jeremy Lewis in 
2020 concluded that continued research is needed to more fully understand the uncertainty 
around the optimal type, dose, and duration of exercise for sub-acromial shoulder pain. 
All the meta-analysis conducted conclude that strengthening and endurance exercises are 
recommended but the type of exercises are not mentioned and not much emphasis on 
regaining scapular motor control. 
Thus, nearly all current systematic reviews emphasize the need for more high quality trials of 
physiotherapy interventions to optimize the dosimetry of exercise program. 
There is a need for well-designed structured exercise program in detail considering content, 
dosage and progression to guide treatment for patients with sub acromial pain. This demands 
developing a specific guidance on how exercise interventions should be reported in clinical 
trials depending on what structure is affected in intrinsic and extrinsic mechanisms of 
subacromial impingement syndrome. 
The term conventional physiotherapy is uninterpretable and inconclusive especially because 
there is presumption of how exactly the exercise program is formed. Many of the exercise 
program do not provide adequate information of what and why interventions are used. There 
are many varieties of exercises with different rationale and techniques. Hence, it is mandatory 
to have an adequate description of techniques making up the intervention and rationale for 
dosage is essential i.e. the number of sessions, intensity, and duration of intervention as per 
the TIDieR checklist (Template for Intervention description and replication). 
Involvement of shoulder rehabilitation experts in developing the template through an 
international Delphi consensus project will accelerate this project. 
Structured exercise regime for SIS would consist of exercises based on movement 
dysfunctions and biomechanical derangements commonly seen in patients with impingement. 
These patients tend to have anterior tipping and downward rotation of scapula along with 
internally rotated humeral head. Correction of the biomechanical faults would off load the sub 
acromial space and reduce the pain. The technique used to correct the biomechanics is called 
"load modification or Shoulder symptom modification process" And involves 4 techniques: 
1. Alterations to thoracic kyphosis 
2. Scapular positioning techniques 
3. Humeral head positioning procedures 
4. Pain and symptom neuromodulation procedure. 
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Exercise protocol based on these 4 categories will help produce a better treatment outcome 
as compared to conventional Physiotherapy treatment. 
If a standardized exercise program based on latest evidence designed to enable 
implementation into clinical practice is proved effective, the need for surgery might decrease 
and it will help the patients to regain the shoulder functions and improve the physical activities 
as well as quality of life. 
 
 
Evaluation and implementation of physical activity and exercise research would be greatly 
facilitated if exercise programs and their components were comprehensively reported in 
clinical trials in a standardized way. 
The proposed exercise program will provide explicit data about whether exercises are generic 
or individualized, the type of exercise equipment used, the exercise starting position and the 
program starting point, the degree of load or resistance, rules for exercise progression, 
motivation and adherence strategies, and exercise duration, repetitions, sets and sequence. 
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4. Objectives 
 
Research Question 
Is there a difference in the effectiveness of structured exercise program as 
compared to conventional exercise program on pain, range of motion and 
functions in patients with sub acromial impingement? 
 
Hypothesis 
Null Hypothesis (H0): 
 
There will be no difference in the effectiveness of structured exercise 
program and conventional exercise program in the individuals with sub 
acromial pain. 
 
 
Alternative Hypothesis (H1): 
 
There will be significant difference in the effectiveness of structured exercise 
program and conventional exercise program in the individuals with sub 
acromial pain. 
 
 
 
Aim and objectives 
 
 
Aim- To develop and validate a structured exercise protocol and to assess its 
effectiveness in patients with sub-acromial impingement syndrome. 
 
Objectives- 
Phase 1: 
1. To develop and validate a structured exercise program 
 
Phase 2: 
 
 
Primary Objectives: - 
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1. To evaluate efficacy of structured exercises on pain, range of motion and 
shoulder functions using Constant Murley score and Shoulder Pain and 
Disability Index (SPADI) and functional performance using timed functional 
arm and shoulder test. 
 
2. To compare the effectiveness of structured exercises and conventional 
exercises on pain, range of motion and shoulder functions using Constant 
Murley score and Shoulder Pain and Disability Index (SPADI) and functional 
performance in patients with sub acromial impingement syndrome. 
 
 
 
5. Indicate if this is a retrospective data review 
This is a prospective study 
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6. Study Methodology 
 
Objective 1: Development of a structured exercise program in patients with sub acromial 
impingement syndrome. 
 
 
1. Through the extensive literature review, the exercise program would be proposed as per 
the rationale of altered biomechanics and structures affected in sub acromial impingement 
syndrome. 
 
 
2. The structured exercises program will be developed in systematic way to describe 
intervention, inclusive of rationale (why); materials that were used (what); procedures (what); 
how, where, when, how much, and by whom training will be provided, how it will be tailored 
and modified and how well planned it will be. 
 
 
3. Structured exercise program will be formed as per the guidelines of TIDieR items which will 
include the name of the intervention; intervention rationale for essential elements; 
intervention materials and details about how to access them; description of the intervention 
procedures; details of intervention providers; mode of delivery of intervention; location of 
intervention delivery and key infrastructure; details about the number, duration, intensity, and 
dose of intervention sessions; details of any intervention tailoring; any intervention 
modifications throughout the study; and details of intervention assessment, monitoring, and 
level achieved. 
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4. Exercise protocol based on following four categories will be proposed to correct the 
biomechanics as per "load modification or Shoulder symptom modification process" 
1. Pain and symptom neuromodulation procedure. 
 
2. Scapular positioning techniques 
 
3. Humeral head positioning procedures 
 
4. Alterations to thoracic kyphosis. 
 
 
This intervention will be based on shoulder kinetic control, load modification exercises 
and lumbopelvic stabilization with core stability exercises which is not a part of 
conventional exercise program for shoulder impingement syndrome patients. 
Retraining exercises for scapular control 
 
1. 
Dissociate flexion to 90°. 
5-10 repetitions x2. 
2. 
Dissociate abduction to 90°+ rotation timing 
5-10 repetitions x2 
3. 
Dissociate medial rotation – supine arm abducted 90° 
5-10 repetitions x2 
4. 
Dissociate lateral rotation – standing arm by side 
5-10 repetitions x2 
5. 
Dissociate extension to 15° + rotation timing 
5-10 repetitions x2 
6. 
Dissociate lateral rotation – prone arm overhead (wrist 
lift) 
5-10 repetitions x2 
7. 
Dissociate medial rotation – prone arm overhead 
(elbow lift). 
5-10 repetitions x2 
8. 
Full range overhead movement – flexion and 
abduction 
5-10 repetitions x2 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
exercises twice daily. 
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Retraining exercise for glenohumeral control 
 
1. 
Dissociate lateral rotation – standing arm by side. 
5-10 repetitions x2 
2. 
Dissociate medial rotation – supine arm abducted 
90°. 
5-10 repetitions x2 
3. 
Dissociate extension to 15°. 
5-10 repetitions x2 
4. 
Dissociate lateral rotation – prone wrist lift. 
5-10 repetitions x2 
5. 
Dissociate medial rotation – prone elbow lift. 
5-10 repetitions x2 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
exercises twice daily. 
 
 
 
Hook-lying Stabilization Progression 
 
 
 
1. 
Neutral position 
5-10 repetitions x2 
2. 
Hook-lying with Arm Movements 
5-10 repetitions x2 
3. 
Bent Knee to Side 
5-10 repetitions x2 
4. 
Heel Slides 
5-10 repetitions x2 
5. 
Bent Knee Leg Lift (small steps) 
5-10 repetitions x2 
6. 
Alternate Arm and Leg Marching 
5-10 repetitions x2 
7. 
Curl-up 
5-10 repetitions x2 
8. 
Curl-up with Rotation 
5-10 repetitions x2 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
exercises twice daily. 
 
Hands and Knees Stabilization Progression 
 
1. 
Neutral Position 
5-10 repetitions x2 
2. 
Rocking Forward and Backward 
5-10 repetitions x2 
3. 
Arm Slide and Reach 
5-10 repetitions x2 
4. 
Leg Slide and Reach 
5-10 repetitions x2 
5. 
Opposite Arm and Leg Slide and Reach 
5-10 repetitions x2 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
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exercises twice daily. 
 
 
 
Face-down Stabilization Progression 
 
1. 
Neutral Position 
5-10 repetitions x2 
2. 
Face-down One-arm Lift 
5-10 repetitions x2 
3. 
Face-down Knee Bend/Lift 
5-10 repetitions x2 
4. 
Face-down Arm/Leg Lift 
5-10 repetitions x2 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
exercises twice daily. 
 
 
Bridging Stabilization Progression 
 
1. 
Basic Bridge 
5-10 repetitions x2 
2. 
Bridge with Arm Lift 
5-10 repetitions x2 
3. 
Bridge with Leg Lift, 
5-10 repetitions x2 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
exercises twice daily. 
 
 
The grid of exercise with dosimetry will be constructed as per the experts’ opinion in 
first round of Delphi and will be finalized in further rounds by following TIDieR 
checklist (Template for Intervention description and replication). 
 
 
 
Phase 2: The newly developed structured exercise protocol will be implemented in patients 
with subacromial impingement syndrome. 
Random allocation of subjects who meet inclusion and exclusion criteria and give consent 
for the study will be allocated to either of the two groups by table of random sequence 
generation generated by Graph Pad. 
Patients will be “randomized” into one of two treatment groups. Patients blinding is not 
needed, as they will be in either of the group. 
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• Patients will be put into a group by chance. Neither patients nor the researchers 
choose which group they will be in. Patients will have equal chance of being placed 
in a specific group. 
• Allocation will be done by an independent person who is not aware of the aim and 
objectives of the study thus assigning participants into interventional group A and 
interventional group B. 
• Co-investigator will do the follow up assessments hence blinding of principal 
investigator will be possible. 
 
Group A (Experimental Group) will receive structured exercises for 12 weeks and 
Group B (control group) will receive conventional exercise program for 12 weeks. 
The treatment protocol will be given approximately for two days per week for twelve weeks. 
But the actual treatment frequency and duration after finalization of new protocol. 
The treatment protocol will be participant specific and progression will be made according 
to the participant’s performance. 
Assessment will be done at baseline, 3, 6, 9, and 12 weeks in both the groups. 
In the literature review, previous studies have mentioned feasible duration of approximately 
12 weeks with twice or thrice sessions in a week. However, this will be finalized after 
development and validation of exercise program with consensus of experts. 
 
The patient’s treatment will continue even after12 weeks if needed. 
 
 
 
Type of Study Design: An experimental study. 
Sampling Method: Random allocation method 
Study Setting: Musculoskeletal Physiotherapy OPD 
Duration of study: 3 years 
Calculation of sample size- 
 
Phase 1: 
Eight to ten experts in the field of shoulder rehabilitation with minimum 10 years of clinical 
experience will be recruited for Delphi method. 
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Pilot testing of structured exercise program: Pilot testing will be done on 8 patients in 
experimental group and 8 patients in control group. 
 
Phase 2: 
 
Sample size was determined using the estimates of mean and standard deviation values 
from literature. 
Reference: Debashree Mitra, P.K Mitra et al. Effect of Specific Exercise Program and 
Conventional Exercise Protocol on Pain and Disability in Patients with Subacromial 
Impingement Syndrome. International Journal of Health Sciences and Research. 2019; 9 
(8):132-139. 
Using the formula 
 
n = 
2 (Zα+ Zβ)2 [s]2 
 
d2 
 
Where Zα is the z variate of alpha error i.e. a constant with value 1.96, Zβ is the z variate of 
beta error i.e. a constant with value 0.84. 
Minimally clinical difference was calculated by dividing the individual patient change score 
 
by the square root of the SEM. The RCI was considered to confer a true change when it is 
more than 1.96 (95 % confidence) (the z-score corresponding to the desired level of 
significance). 
 
(Reference: Allen JC. Sample Size Calculation for Two Independent Groups: A Useful Rule 
of Thumb. Proceedings of Singapore Healthcare 2011:20(2);138-40) 
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Approximate estimates: 
 
1. 80% power 
 
2. Type I error to be 5% 
 
3. Type II error to be 20% 
 
4. True difference of atleast 0.31 units between the groups (SPADI) 
 
5. Pooled standard deviation of 0.48 
 
 
Substituting the values, 
n = 2 (2.8)2  [0.48]2 
 
(0.31)2 
 
 
 
n = 37.31 
 
Approximately 38 to 40 subjects / patients per group should complete the study at the 
endpoint follow up 
For follow-up studies, to avoid loss by loss to follow up / attrition, kindly consider recruiting 
5-25% more subjects so that even after attrition, we would be able to achieve the required 
minimum sample size. 
 
Also taking into consideration the attrition to be 15% 
n= N / (1-0.15) 
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n = 
38 
 
(1-0.05) 
 
= 44.70 
 
Approximately 45 subjects / patients per group need to be recruited in the present study 
 
 
Assessment will be done at baseline, 3, 6, 9, and 12 weeks in both the groups, which will 
help to detect the changes in outcome measures at, frequent intervals. 
Out of the five outcome measures, 
• Constant Morley part A and SPADI are patient reported scales 
• T Fast is functional test 
• Constant Murley and Scapulothoracic measuresment are ROM assessments 
15% attrition is considered while computing the sample size. 
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7. Study Population and Study Setting/ Location 
 
 
 
Study Setting: Outpatient Physiotherapy Units- Orthopedics 
Qatar Rehabilitation Institute 
 
Inclusion Criteria 
 
 
1. Age group between 18-60 years 
2. Symptoms for more than three weeks 
3. Main complaints in the gleno humeral joint region or the proximal arm 
4. Presence of one of the following signs indicating SAIS: Neer impingement test, Hawkins- 
Kennedy impingement test, painful arc with active abduction or flexion. 
Pain with one of the following resistance tests: external rotation, internal rotation, abduction 
 
 
Exclusion Criteria 
 
 
1. Severe pain; pain is > 7/10 on NRS (0 = no pain) 
2. Shoulder surgery on affected shoulder 
3. Traumatic shoulder dislocation/ fracture within the past 3 months 
4. Previous rehabilitation for this episode of shoulder pain 
5. Reproduction of shoulder pain with active or passive cervical motion 
6. Systemic inflammatory joint disease 
7. Global loss of passive shoulder ROM, indicative of adhesive capsulitis 
8. Full-thickness rotator cuff tear 
9. Incompetent adults 
10.Subjects unable to consent 
11. patients who are unfit to undergo the suggested exercises as per the protocol. 
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8. Study procedures 
 
Phase 1: Development of a structured exercise program in patients with sub acromial pain 
 
 
We will develop and evaluate a structured exercise programs for sub acromial impingement 
syndrome using an expert consensus with Delphi-based survey technique. 
 
 
Modified Delphi technique 
 
• Eight to ten experts in the field of Musculoskeletal physiotherapy with focus on 
shoulder rehabilitation with minimum 10 years of clinical experience will be recruited 
for Delphi method. Experts are defined as individuals involved in the conception, 
design, conduct, teaching or analysis of exercise interventions. 
• Sixty percent experts will be from physiotherapy discipline and forty percent would be 
orthopedic surgeons. There are no laypersons. 
• Experts who respond to pre-Delphi invitations will be chosen to participate in the first 
round. 
• The participant information sheet will be provided to the experts and consent will be 
obtained after they are willing to participate. 
• Experts will be provided the facility to complete it over several sessions and to allow 
reviewing their answers before final submission of their responses. 
• In the first round, participants will be asked to rank the importance of items they will 
also be asked to provide recommendations regarding any additions and/or deletions 
to the list of proposed items and for any other comments/suggestions. 
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• Only those who complete round one will be invited to participate in round two. De- 
identified results comprising overall scores for each item and narrative summary of 
findings, comments and suggestions will be sent to each panel member after the 
first round. In a second round, all ambiguous items or proposals driven by comments 
of the first round and concerning exclusion, aggregation or retention of items, 
together with any new potential items identified from the first round, will be included 
in the second survey. 
• The final exercise protocol will be distributed to the panel members for final approval 
with decision rules for each item and guidance on how some information may best 
be presented and elaboration and explanatory document will be developed. 
• Following the second round, a ranking of item importance will be made to rationalize 
the number of items and model this according to the CONSORT Statement and 
TIDieR Checklist for consistency. Synthesis of comments and further additions and 
deletions will be made until there is final majority agreement. It is anticipated that 
three rounds will be required. Rounds will continue until consensus is achieved. 
More than 80% of response rate will be acceptable in Delphi study. 
• Results from the final round will be summarized and distributed to the entire group 
for final remarks. The final document, including all phase wise exercises will be 
accepted and research team will validate it. 
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• Pilot testing of a newly developed exercise program will be done on eight patients in 
experimental group and eight patients in control group. Response of the patients 
(self-reported parameters – such as ease of doing it etc.) will be checked. 
• Evaluation of the patients will be done at the baseline using Constant Murley Score, 
shoulder pain and disability Index (SPADI). Shoulder range of motion, shoulder 
muscles extensibility will be assessed and scapulothoracic ratio will be calculated 
and documented. T-FAST test will be conducted to score the patients functional 
performance. 
 
 
STUDY PROCEDURE: - 
 
 
Phase 2: 
A randomized controlled trial will be conducted as per the guidelines/statement given by 
CONSORT 2010 (Consolidated Standards of Reporting Trials). 
 
 
 
Evaluation of the participant will be done at the baseline using Constant Murley Score, 
shoulder pain and disability Index (SPADI). Shoulder range of motion, shoulder muscles 
extensibility will be assessed and scapulothoracic ratio will be calculated and documented. 
T-FAST test will be conducted to score the patients functional performance. 
specified timeframes for phase 1 and phase 2 
 
 
Sr. No. 
Task 
Timeline 
1. 
Phase 1: developing and validating the 
structured exercise program 
6 months 
2. 
Pilot phase 
6 months 
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3. 
Phase 2: RCT, implementation of 
exercise program 
2 years 
 
 
 
 
 
 
 
Outcome measures: 
 
 
1. Constant–Murley Score 
This score is a shoulder-specific assessment tool containing objective measures (range of 
movement and shoulder strength) and subjective measures (activity of daily living and pain). 
The maximum is 100 points and indicates excellent shoulder function. 
The CMS scale assesses four aspects related to shoulder pathology; two subjective: pain 
and activities of daily living (ADL) and two objectives: range of motion (ROM) and strength. 
The subjective components can receive up to 35 points and the objective 65, resulting in a 
possible maximum total score of 100 points (best function). Pain and ADL are answered by 
the patient; ROM and strength require a physical evaluation and are answered by the 
physiotherapist. 
Questions and measurements are standardized according to the original description by 
Constant and Murley. 
 
 
2. Pain perception 
The visual analogue scale (VAS; 0–10) is used to assess the patient’s perceived pain 
intensity at rest, during arm activity and at night during the previous 24 hours at each follow- 
up. 
 
 
3. Shoulder Pain and Disability Index (SPADI) 
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that 
consists of two dimensions, one for pain and the other for functional activities. The pain 
dimension consists of five questions regarding the severity of an individual's pain. Functional 
activities are assessed with eight questions designed to measure the degree of difficulty an 
individual has with various activities of daily living that require upper-extremity use. The 
SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid 
region-specific measure for the shoulder. 
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4. Timed Functional Arm and Shoulder Test 
Description of the Timed Functional Arm and Shoulder Test. 
Hand to head and back: This test is timed for 30 seconds. Each time the patient touches the 
back of his or her head, it counts as 1 repetition. Begin with the unaffected arm or dominant 
arm at the side of the body. 
Reach up and touch the back of the head (A). Any part of the hand touching the head is 
acceptable. Ideally, the full palm should be touching. After the patient touches the back of 
the head, bring the arm down and place the dorsal surface of the hand on the small of the 
back (B). Repeat the motion for the duration of the test. 
\Wall wash outward and inward: This test is timed for 60 seconds in each direction. The 
center of the circle should be at the shoulder height of the patient. Measure 6 inches up, 
down, left, and right to mark off a 12-inch-diameter circle. Begin the test with the hand on 
the top mark. Keeping the hand in full contact with the wall, rotate internally (inward) so that 
the towel/hand touches each of the 4 marks (C). Each time the hand passes the top mark, 
it counts as 1 rotation. Record the score. 
For the outward wall-wash motion, begin the test with the hand on the top mark. Keeping 
the hand in full contact with the wall, rotate externally (outward) so that the towel/hand 
touches each of the 4 marks (D). Each time the hand passes the top mark, it counts as 1 
rotation. Record the score. 
Gallon-jug lift: This test is timed for 30 seconds. Starting counter height should be 36 inches, 
and the shelf should be 20 inches above the counter (56 inches off the floor). Begin with a 
full gallon jug on the counter (E). Lift the jug to touch the shelf and return to start (F). Every 
time the jug touches the shelf, it counts as 1 repetition. Record the score. 
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5. Scapulothoracic ratio Measurement 
Two inclinometers will be used to measure humeral elevation and scapular upward rotation 
in 30, 60 and 90 degrees of arm elevation during flexion and abduction. Using an 
electromagnetic tracking system, Johnson et al. (2001) validated use of the inclinometer to 
quantify scapular upward rotation associated with varying amounts of humeral elevation (r 
¼ 0.66e0.89) with good Intraclass correlation coefficient (ICC ¼ 0.86e0.91) for 
measurement of scapular upward rotation. 
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Step 1: Assessment of glenohumeral range of motion with inclinometers 
● First inclinometer will be attached parallel to the humerus, just under the deltoid insertion 
with the use of Velcro straps. 
● Standing posture and postural sway will be controlled by asking subjects to look at target 
approximately 2m ahead of them positioned at eye level. 
● Range of motion will be documented by inclinometer in sagittal and frontal plane at 
glenohumeral joint in arm elevation. 
● Three trials with 30 seconds rest in between the trials will be done, and means of them 
will be calculated. 
 
 
Assessment of scapular upward rotation: 
● Scapular upward rotation will be measured using a second inclinometer; this will be 
achieved by manually aligning the base of the inclinometer along the spine of the scapula. 
● Range of scapular upward rotation will be documented by an inclinometer in the sagittal 
and frontal plane in arm elevation in 30, 60, 90 degrees and in the available end range. 
● Three trials with 30 seconds rest in between the trials will be done, and means of them 
will be calculated. 
Step 2: Deriving scapulohumeral ratio: 
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● The ratio of glenohumeral motion to scapular motion will be then calculated to derive 
scapulohumeral rhythm i.e. Glenohumeral motion = total shoulder motion – scapular upward 
rotation 
● Scapulohumeral rhythm = Glenohumeral elevation / scapular upward rotation While 
assessing range of motion at glenohumeral joint assessment of end feel, joint reactivity and 
irritability will be done with Maitland concept. 
 
 
The conventional exercise program for control group 
Phases 
Maximal protection: acute phase 
Goals 
• Relieve pain and inflammation 
• Normalize range of motion 
• Reestablish muscular balance 
• Improve posture 
• Patient education and avoidance of aggravating activities 
• Elimination of any activity that causes an increase in symptoms 
Range of motion (5-10 repetitions x2.) 
• L-Bar 
• Flexion 
• Elevation in scapular plane 
• External and internal rotation in scapular plane at 45° abduction 
• Progress to 90° abduction 
• Horizontal abduction/adduction 
• Pendulum exercises 
• Active-assisted range of motion: limited symptom-free available range of motion 
• Rope and pulley 
• Flexion 
Joint mobilizations 
• Inferior and posterior glides to the GH joint in the scapular plane 
• Goal is to establish balance in the glenohumeral joint capsule 
Modalities 
Cryotherapy/ Hot pack 10 minutes 
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Strengthening exercises (10-15repetitions x 3). 
• Rhythmic stabilization exercises for External rotation/ Internal rotation 
• Rhythmic stabilization drills Flexion / Extension 
• External rotation strengthening 
• If painful, isometrics (External rotation, Internal rotation, abduction) 
• Scapular strengthening 
 
 
Postural exercises stretch (30 seconds stretch x 3). 
• Strengthen scapular muscles (depressors, retractors, and 
• protractors) 
• Stretch pectoralis minor (corner stretch) 
• Wall circles 
Patient education 
• Educate patient regarding activity level, activities 
• Pathology and avoidance of overhead activity, reaching, and lifting activity 
• Correct seating posture (consider lumbar roll) 
• Seated posture with shoulder retraction, scapular external rotation, posterior tilting 
• Consider postural shirt for patients with poor posture 
Guideline for progression 
• Decreased pain and/or symptoms 
• Normal range of motion 
• Elimination of painful arc 
• Muscular balance 
 
 
Intermediate phase 
Goals 
• Reestablish nonpainful range of motion 
• Normalize arthrokinematics of shoulder complex 
• Normalize muscular strength 
• Maintain reduced inflammation and pain 
• Increase activities with involved arm 
Range of motion (5-10 repetitions x2.) 
• L-Bar 
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• Flexion 
• External rotation at 90° of abduction 
• Internal rotation at 90° of abduction 
• Horizontal abduction/adduction at 90° 
• Rope and pulley 
• Flexion 
Joint mobilization 
• Continue joint mobilization techniques to the tight aspect of the 
• shoulder (especially inferior) 
• Initiate self-capsular stretching 
• Grades 2, 3, 4 
• Inferior, anterior, and posterior glides 
• Combined glides as required 
Modalities (as needed) 
Cryotherapy/ Hot pack 10 minutes 
Ultrasound 3 MHZ /5 minutes 
 
Postural exercises (5-10 repetitions x2.) 
• Continue with stretching of pectoralis minor and strengthening scapular muscles 
• Continue use of postural shirt 
• Strengthening exercises 
• Progress to complete shoulder exercise program 
• Emphasize rotator cuff and scapular muscular training 
• External rotation tubing 
• Side lying external rotation 
• Full can 
• Shoulder abduction 
• Prone horizontal abduction 
• Prone shoulder extension 
• Prone rowing 
• Prone horizontal abduction external rotation 
• Biceps/triceps 
• Lower trapezius muscular strengthening 
• Scapular neuromuscular exercises 
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Functional activities 
• Gradually allow an increase in functional activities 
• No prolonged overhead activities 
• No lifting activities overhead 
Advanced strengthening phase 
Goals 
Improve muscular strength and endurance 
Maintain flexibility and range of motion 
Maintain postural correction 
Gradual increase in functional activity level 
Flexibility and stretching 
Continue all stretching and range-of-motion exercises 
L-Bar: External rotation /internal rotation at 90° abduction 
Continue capsular stretch 
Maintain/increase posterior/inferior flexibility 
 
 
Strengthening exercises (5-10 repetitions x2.) 
• Establish patient on the fundamental shoulder exercises 
• Tubing external rotation /internal rotation 
• Lateral raises to 90° dumbbell 
• Full can dumbbell to 90° 
• Side lying External rotation 
• Prone horizontal abduction 
• Prone extension 
• Wall slides 
• Biceps/triceps 
• Scapular neuromuscular control drills 
 
 
Guideline for progression to phase 4 
• Full, nonpainful range of motion 
• No pain or tenderness 
• Strength test fulfills criteria 
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• Satisfactory clinical examination 
Return to activity phase 
Goals 
Unrestricted, symptom-free activity 
 
 
The exercises to be performed at the PT clinic 2 times a week combined with home 
exercises twice daily. 
 
 
Any dropouts or participants lost to follow-up will be mentioned with appropriate reasoning. 
At the end of the study the data will be collected, coded and tabulated using descriptive and 
inferential statistics. All analysis will be done using SPSS for Windows (Version 16). 
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9. Study Duration and Timelines 
 
Total duration of study: 3 years 
The treatment protocol will be given for two days per week for twelve weeks. 
Each treatment session will be for 45 mins. 
Assessment will be done at baseline, 3, 6, 9, and 12 weeks in both the groups. 
The treatment protocol will be participant specific and progression will be made according 
to the participant’s performance. 
specified timeframes for phase 1 and phase 2 
 
 
 
Sr. No. Task 
Timeline 
1. 
Phase 1: developing and validating the structured 
exercise program 
6 months 
2. 
Pilot phase 
6 months 
3. 
Phase 2: RCT, implementation of exercise program 
18 months 
 
Timeline for the entire study 
 
 
 
Sr. No. 
Task 
Timeline 
2. 
Related Literature Search 
September 2022 
6. 
Institutional Ethical Committee Approval 
October- 
December 2022 
9. 
Data Collection Post MRC Approval 
February 2023- 
February 2025 
10. 
Data Presentation and Analysis 
March 2025 
11. 
Writing Discussion and Conclusion 
June 2025 
12. 
Preparing manuscript and publication 
August 2025 
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10. Informed Consent 
 
 
The patients who are endorsed in physiotherapy OPD will be approached to consider being 
a research subjects, Principal investigator will be taking informed consent from the patients. 
Participants can take 24-72 hours to decide on participation in research. Subjects will be 
screened for eligibility criteria as per the inclusion and exclusion criteria, Subjects will be 
enrolled in the study through simple random method. 
 
 
 
 
11. Risk 
 
Potential risks associated with this study are none or very minimal. The time required is 45 
minutes is the only discomfort which will be having throughout the study. There is possibility 
of increase in shoulder pain after exercises which will be managed with pain relieving 
electrotherapeutic modalities. 
The therapist will always be in the vicinity to prevent and treat the same. 
 
 
 
12. Outcomes 
 
The effect of structured exercises on pain, range of motion and shoulder functions using 
Constant Murley score and Shoulder Pain and Disability Index (SPADI) and functional 
performance using timed functional arm and shoulder test will be tested and compared with 
conventional exercise program. 
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13. Data Collection, Management & Confidentiality 
 
 
a) Indicate below HOW study data will be collected for the proposed research. 
 
√ 
Study Forms 
Study Database 
Study Web-Based/App 
Other 
 
A standardized data collection tool will be developed. Variables will be designated to 
measure the pre specified outcomes. 
 
The subject data will be coded by Alphanumeric notations. The subject name and the 
number will be coded and the subject identifier will be kept locked in the drawer. Subject 
identifiers- Name, HC number and Date of Birth (DOB) will not be included in the data 
collection sheet. Subject identifiers will be logged in the subject code and identification list. 
 
Data collection sheet and other confidential documents will be kept inside the cupboard, 
which will be locked, and only Principal investigator will have the access, which will be limited 
to the study personal and MRC personal. Only the research team that includes the Principle 
investigator will have access to the data. In addition, the Medical research Centre will be 
having access along with the other regulatory bodies in Qatar. The study identifiers will not 
be shared outside the HMC except the regulatory bodies. Link between the code and 
Identifier will be stored in the subject code and identification list and will be destroyed after 
the study finishes. De-identified data will be kept for at least 5 years from the completion of 
the study. 
 
 
 
14. Subject Withdrawal/ Withdrawal of Consent 
The subject can request to be withdrawn from the study at any time during the study period. 
The PI will withdraw the subject & his/ her consent from the study and will notify the research 
governing bodies of this withdrawal. If subjects sustain any trauma or injury related to 
shoulder joint or undergoes shoulder surgery, PI may have to withdraw a subject from the 
study. 
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15. Statistical Consideration and Data Analysis 
 
Statistical analysis: 
 
Phase 1 
 
In the Delphi method, the results will be analyzed independently in each round. The 
percentages of responses shall be calculated in categories following the consensus analysis 
method of most studies that also adopt the visual scale of 1–5, according to CREDES. 
The percentages of agreement and disagreement shall be calculated for each of the items in 
the exercise protocol. 
When the percentage is greater than or equal to 80%, the statement is considered to have 
reached (dis)agreement consensus. The items that reach consensus are excluded from the 
next round. Finally, those items that have not reached 80% agreement or disagreement will 
be included to the questionnaires of the following rounds with the modifications proposed by 
the panelists, if they consider it necessary. 
 
 
Phase 2 
 
Data collected will be compiled on to a MS Office excel worksheet & will be subjected to 
statistical analysis using an appropriate package like SPSS software. 
Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov 
test. Depending on the normality of data, statistical tests will be determined. 
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For a numerical continuous data following a normal distribution, inter group comparison (2 
groups) will be done using t test, else a non-parametric substitute like Mann Whitney U test 
will be used. 
Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard 
deviation of numerical data in each group will be depicted & may be compared using chi 
square test or a suitable test like Fisher’s exact test / McNemar test based on the data 
obtained. 
Intra group comparisons for a numerical continuous data following a normal distribution will 
be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 
observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 
observations) or Friedman’s test for >2 observations will be used. 
Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered 
statistically significant. 
For the primary end-point, namely SPADI score after 12 weeks, and for all other outcomes, a 
constrained linear mixed model (cLMM) will be applied in order to compare the change from 
baseline to 12 weeks in experimental and control group. 
 
 
Principal investigator with the help of bio stastician will be carrying out the data analysis. 
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16. Adverse Event Reporting 
 
All research related incidents through the OVA/Electronic Incident Reporting System no later 
than 24 hours for all SAE’s covered in the SOP in accordance to Policy OP 4070 
REPORTING OF OCCURRENCES, VARIANCES AND ACCIDENTS. 
Unanticipated Problems that are serious will be reported to HMC-IRB within 7 days of the 
investigator becoming aware of the event. 
Any other Unanticipated Problems will be reported to HMC-IRB within 14 days of the 
investigator becoming aware of the event. 
 
 
 
 
17. Ethical Consideration 
 
The study will be conducted in full conformance with principles of the “Declaration of 
Helsinki”, Good Clinical Practice (GCP) and within the laws and regulations of MoPH in 
Qatar 
 
 
 
 
 
18. Sponsor, Funding & Collaborator Information 
 
Sponsor and funding: None 
This is a PhD study. 
The name of the research Centre: PT School and Centre, Seth G.S.Medical College and 
KEM Hospital, Mumbai, Maharashtra, India 
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19. Dissemination of Results and Publication policy 
The results will be disseminated during PhD presentations at Research Centre as well as at 
university. Two international publication are mandatory throughout duration of PhD as per 
the PhD guidelines. 
 
 
 
20. References 
 
 
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21. Appendices 
 
Appendix 1: Data collection tool 
Appendix 2: Informed consent document 
Appendix 3: Constant Murley score 
Appendix 4: SPADI. 
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