The PainSMART Project: A Research Program on Effectiveness, Mechanisms of Effect and Patient-practitioner Experiences of the PainSMART-strategy as an Adjunct to Usual Primary Care Physiotherapy Management for Musculoskeletal Pain
Phase: NA
Conditions: Pain, Pain Acute, Pain, Chronic, Self Efficacy, Illness Perceptions, Physical Activity Level, Sickness Absence, Referral and Consultation, Worry, Anxiety, Patient-Centered Care, Communication
Sponsor: Kajsa Johansson

 
 
 
 
 
Study protocol  
 
 The PainSMART Project: Protocol for a 
research program on effectiveness, 
mechanisms of effect and patient-
practitioner experiences of the 
PainSMART-strategy as an adjunct to 
usual primary care physiotherapy 
management for musculoskeletal pain 
 
 
 
 
2024 September 25 
ClinicalTrials.gov ID: NCT06187428 
Version 1.2 
 

 
 
The PainSMART Project: Protocol for a research program on 
effectiveness, mechanisms of effect and patient-practitioner 
experiences of the PainSMART-strategy as an adjunct to usual 
primary care physiotherapy management for musculoskeletal pain 
This protocol follows the Standard Protocol Items: Recommendations for Interventional 
Trials (SPIRIT) statement and the SPIRIT-Patient Reported Outcomes guidelines (Chan et al., 
2013; Calvert et al., 2021) 
Registration 
Version 1.2. Issue date: September 25, 2024 
ClinicalTrials.gov identification number: NCT06187428 
Funding 
Funding for this project was received from the Medical Research Council of Southeast 
Sweden (Swe: Forskningsrådet i Sydöstra Sverige; FORSS) and from the Primary Care 
research fund (Swe: Primärvårdsforskningsfonden), Region Östergötland, Sweden. The 
funding sources had no role in the study design and will not have any role in its execution, 
analyses, interpretation of data or decision to submit results. 
Roles and responsibilities 
Kajsa Johansson, Senior Associate Professor, RPT, Department of Health, Medicine and 
Caring Sciences, Unit of Physiotherapy, Linköping University, Sweden. Principal supervisor 
& head of the PainSMART-research project.  
Allan Abbott, Professor, RPT, Department of Health, Medicine and Caring Sciences, Unit of 
Physiotherapy, Linköping University, Sweden. Co-supervisor PainSMART-project  
Ann-Sofi Kammerlind, Associate Professor, RPT, Department of Health, Medicine and 
Caring Sciences, Unit of Physiotherapy, Linköping University and FUTURUM Region 
Jönköping, Sweden. Research group member PainSMART-project.  
Pia Tingström, Senior Associate Professor, RN, Department of Health, Medicine and Caring 
Sciences, Division of Nursing Sciences and Reproductive Health, Linköping University, 
Sweden. Research group member PainSMART-project. 
Richard Thompson, PhD student, Department of Health, Medicine and Caring Sciences, Unit 
of Physiotherapy, Linköping University. RPT, Rehab Finspång. Project coordinator 
PainSMART-project. 
Maria Fors, PhD, Department of Health, Medicine and Caring Sciences, Unit of 
Physiotherapy, Linköping University, Sweden. RPT, Rörelse & Hälsa, Linköping. Post-
doctoral researcher PainSMART-project. 
All authors contributed to study design and production of the study protocol.  
Authors’ contact details 
Project coordinator & corresponding author: Richard Thompson. Email: 
richard.thompson@regionostergotland.se. Telephone: +4670851962 
Head of the PainSMART-research project: Kajsa Johansson: kajsa.johansson@liu.se 

 
 
Study sponsor contact details 
Forskningsrådet i Sydöstra Sverige (FORSS). 
Medical Research Council of Southeast Sweden 
581 91 Linköping, Sweden  
Email: agneta.andersson@regionostergotland.se  
Telephone: +46730917985 
Introduction 
Background and rationale  
Musculoskeletal disorders are a major health problem and entail a significant burden for 
individuals and healthcare systems (Liu et al., 2022). In Sweden, musculoskeletal disorders, in 
particular spinal pain, are one of the leading causes of disability and their burden is increasing 
(Vos et al., 2020). As of February 2023, around 33,000 people in Sweden were unfit to work 
due to musculoskeletal disorders (Försäkringskassan, 2023). Approximately 30,000 unique 
individuals visit primary care physiotherapy departments within the Östergötland healthcare 
region (population 450 000) for musculoskeletal disorders each year (2017-2022; Rebus Vård, 
Region Östergötland, 2023). High-value musculoskeletal healthcare is therefore imperative 
for individuals, healthcare systems and society at large (Elshaug et al., 2017). With an 
increasing demand for services there is a need to move towards new ways of managing 
musculoskeletal pain (MSKP). The ‘Nära Vård’ (Close care) initiative in Sweden has been 
developed with the aim of creating a more patient-centered, accessible healthcare system 
where practitioners and patients share responsibility for managing the patient’s health 
(Sweden’s councils & regions [Swe: Sveriges Kommuner och Regioner] 2022; Region 
Östergötland 2022). Part of this initiative involves the evolution of healthcare pathways 
(Sweden’s councils & regions 2022; Region Östergötland 2022). 
Managing MSKP is complex and depends on an array of biopsychosocial factors. Improving 
MSKP care requires a paradigm shift in the understanding of pain and an increased focus on 
helping people deal simply with MSKP episodes (Caneiro et al., 2020; O’Sullivan et al., 
2019). Effective early management of MSKP is critical as prolonged activity in the nervous 
system may drive neuroplastic changes that make pain more difficult to treat (Caneiro et al., 
2020; Kiverstein et al. 2022; Moseley & Butler, 2017; Moseley & Vlayean, 2015; O’Sullivan 
et al., 2019). According to the Common-sense model of self-regulation (CSM), how an 
individual manages MSKP depends on how they perceive their MSKP, what coping strategies 
they adopt and how their MSKP progresses over time (Leventhal et al., 2016). A significant 
body of evidence supports the CSM and indicates that more negative MSKP illness 
representations are associated with increased pain intensity and poorer physical function 
(Caneiro et al., 2020; De Raaij et al., 2018). The influence of MSKP illness perceptions are 
further highlighted by modern pain theories, such as the predictive processing theory, that 
consider pain the product of an individual’s perception of the potential threat to bodily 
integrity (Kiverstein et al. 2022; Moseley & Butler, 2017). As such, an individual’s MSKP 
experience is regulated by the meaning, perceived causes and consequences they assign to 
their MSKP (Melzack 2001; Kiverstein et al. 2022; Moseley & Vlayean, 2015; Moseley & 
Butler, 2017). For example, it is common amongst the general public and even some 
healthcare professionals, for the body to be likened to a machine and MSKP considered a sign 
of damage (Caneiro et al., 2020; Toye et al., 2013; Setchell et al., 2017). Such misconceptions 
have been reported to lead to increased pain intensity, disability, use of passive coping-
strategies, over-medicalisation and an overuse of imaging and surgical interventions that are 
often iatrogenic (Buchbinder et al., 2020; Caneiro et al., 2020; De Raaij et al., 2018). Other 
psychological factors, such as pain self-efficacy or psychological flexibility, further influence 

 
 
an individual’s management of MSKP and affect prognosis (Caneiro et al., 2020; Martinez-
Calderon, 2018). For instance, pain self-efficacy, defined as the perception of one’s ability to 
carry out activities when in pain, has been found to link pain to disability, whilst higher pain 
self-efficacy is thought to be protective of the development of chronic MSKP (Lee et al., 
2015; Martinez-Calderon et al., 2018; Miles et al., 2011). Psychological flexibility has been 
found to be significantly associated with physical function whilst fear of movement, fear of 
pain and avoidant or passive coping strategies are risk factors for the development of chronic 
pain (Bruls et al., 2015; Caneiro et al., 2020; Delotti et al., 2012; Hartvigsen et al., 2018; 
Vowles et al., 2014). Collectively, this literature highlights why MSKP illness perceptions 
and psychological factors, such as pain self-efficacy, are considered important targets for 
MSKP interventions.  
Educational interventions have the potential to improve outcomes for people with MSKP by 
targeting factors such as MSKP illness perceptions and pain self-efficacy. However, more 
evidence is required to establish the most effective educational interventions. The need for 
improved MSKP educational materials was highlighted in 2020 when The Lancet published a 
list of ten recommendations to improve care of low back pain (LBP) (Buchbinder et al., 
2020). Six of these recommendations stated the need for improved educational and self-care 
support materials and the need to scientifically evaluate such materials (Buchbinder et al., 
2020). Previous evidence has shown that online and in-person MSKP educational 
interventions can have positive effects on pain intensity and disability (Foster et al., 2018; de 
Oliveira Lima et al., 2021; Tegner et al., 2018; Traeger et al., 2019). However, these studies 
have only included chronic pain populations, been limited to LBP or used educational 
interventions based on outdated pain theories and not developed in collaboration with people 
with MSKP (Foster et al., 2018; de Oliveira Lima et al., 2021; Tegner et al., 2018; Treager et 
al., 2018). National and international guidelines already recommend pain education as 
standard practice for acute and chronic MSKP, but guideline uptake has been poor (Delitto et 
al. 2012; Hartvigsen et al., 2018; National institute for health and care excellence, 2023; 
Nationelltklinisktkunskapsstod.se, 2023). A meta-review found that barriers to the 
implementation of clinical guidelines, such as providing MSKP education, are a lack of time 
for healthcare professionals to keep up to date with research and to communicate research-
based guidelines to patients (Correa et al., 2020). A more efficient MKSP management 
pathway may therefore be facilitated by the development of educational interventions that are 
concise, easily administered and delivered directly to people with MSKP (Correa et al., 2020).  
Communication between people with MSKP and healthcare practitioners can be difficult and 
may be hampered by a divergence in understanding and expectations between the healthcare 
practitioner and the patient (Parsons et al., 2007). For example, qualitative evidence 
consistently finds that people with MSKP want definitive diagnoses and an explanation of the 
cause of their pain (Lim et al., 2019; Toye et al., 2013; Verbeek et al., 2004). However, as 
MSKP is considered an emergent neurophysiological phenomenon explaining it can be 
complex and providing a definitive diagnosis is often impossible (Moseley & Butler, 2017; 
O’Sullivan et al, 2019). A divergence in expectations can therefore arise in a clinical 
consultation when, for example, a physiotherapist approaches MSKP as a complex emergent 
phenomenon and a patient views MSKP through a traditional biomedical lens. Indeed, a 
patient’s lack of knowledge or their uncertainty about their condition has been shown to 
hinder effective consultations and the implementation of evidence-based healthcare (Correa et 
al., 2020; Parsons et al., 2007). An idealistic strategy may be that educational interventions 
are administered prior to a healthcare consultation to help reduce divergence in understanding 
between a patient and healthcare practitioner by providing a shared basis for communication. 
The PainSMART-strategy has been developed in part to address such divergences in 

 
 
understanding. It is hoped that the implementation of the PainSMART-strategy may facilitate 
patient-practitioner interaction around MSKP and result in improved patient outcomes 
compared to usual healthcare management.  
Objectives  
The PainSMART-project is a research program with a collective suite of studies aiming to 
investigate the effectiveness of the PainSMART-strategy, factors associated with outcomes 
and explore patients and physiotherapists experiences. The objective of the PainSMART-
project is to evaluate the effects of administering the PainSMART-strategy as an adjunct to 
usual physiotherapy management compared to usual physiotherapy management alone.  
Hypotheses 
Hypotheses for confirmatory research questions: 
1. Exposure to the PainSMART-strategy as an adjunct to usual physiotherapy 
management improves the following outcomes significantly more than usual 
physiotherapy management alone for patients with MSKP (* = primary outcomes) 
 Reduction in pain intensity*. 
 Higher pain self-efficacy*.  
 Lower MSKP illness perceptions.  
 Higher levels of reassurance of the benign nature of MSKP. 
 More adaptive MSKP coping and psychological flexibility. 
 Higher self-reported levels of physical activity. 
 More positive global ratings of change. 
 Lower number of healthcare visits, referrals for diagnostic imaging and to 
specialist/tertiary care for MSKP, lower analgesic medication use, fewer sick 
leave days and lower direct costs. 
 More positive and concordant patient and physiotherapist evaluations of 
MSKP-related shared understanding, communication, participation, 
involvement and emotional support at the initial physiotherapy consultation.   
2. Improvements in MSKP illness perceptions and higher levels of reassurance of the 
benign nature of MSKP mediate improved pain intensity and pain self-efficacy as a 
result of exposure to the PainSMART-strategy compared to usual physiotherapy 
management alone. 
Null hypothesis (H0): no statistically significant or clinically relevant differences between the 
intervention group (PainSMART-strategy as an adjunct to usual physiotherapy management) 
and the control group (usual physiotherapy management alone).  
Exploratory research questions: 
1. What baseline factors are predictive of improved patient outcomes after exposure to 
the PainSMART-strategy? 
2. What baseline factors are predictive of the persistence of MSKP? 
3. What type of psychological factors and strategies are associated with patient outcomes 
after exposure to the PainSMART-strategy?  

 
 
4. Is pain self-efficacy a potential mediator of the PainSMART-strategy’s effect on 
health outcomes?  
5. What are patients and physiotherapists experiences of the PainSMART-strategy? 
Primary research question for the qualitative phase of the research program: 
 Does exposure to the PainSMART-strategy influence communication around pain at 
the initial physiotherapy consultation? 
Dimensions to explore via the qualitative phase of the research program: 
 Describe how physiotherapist and patient participants incorporate the PainSMART-
strategy into the initial physiotherapy consultation. 
 Explore potential explanations for the quantitative results of the randomized controlled 
trial (RCT). 
 Describe the participating patients’ understanding of MSKP and explore how this may 
relate to the PainSMART-strategy’s theoretical underpinnings. 
 Explore if patients’ understanding of MSKP diverge from the understanding of the 
physiotherapist during the initial consultation.  
Methods 
Trial design 
The PainSMART-project is a research program with a collective suite of studies utilising 
mixed methods, centred on a randomised controlled, superiority trial with two parallel groups. 
A 1:1 group allocation ratio will be applied. The control group and statistician will be blinded. 
One independent statistician will be blinded for the primary analyses. Another independent 
statistician will be responsible for database development and linking of patient and 
physiotherapist data. The results of the RCT will be reported according to the Consolidated 
Standards of Reporting Trials (CONSORT) statement and the CONSORT patient-reported 
outcomes checklist (Calvert et al., 2013; Schulz et al., 2010). The final phase of the RCT will 
include qualitative data collection which will be reported in line with the Consolidated 
Criteria for Reporting of Qualitative research (COREQ; Tong et al., 2007).  
Study setting  
This study is a multi-centre RCT that will be conducted at five primary care physiotherapy 
departments within the Swedish regions of Östergötland (RÖ) and Jönköping (RJL). All four 
physiotherapy departments within RÖ and one physiotherapy department within RJL have 
agreed to participate. Collectively these centres employ around 130 physiotherapists and 
provide initial consultations to approximately 30 000 unique individuals in a one-year period.  
A list of the participating physiotherapy departments is available from the corresponding 
author on request.  
Eligibility criteria 
Potentially eligible patient participants are all adults (18 years or older) seeking primary care 
for MSKP who are triaged and booked for an initial physiotherapy consultation at one of the 
participating physiotherapy departments. Inclusion and exclusion criteria are shown in Table 
1. A flow chart of the patient participants’ path through the study is shown in Figure 1. All 
physiotherapists who provide care to patients booked for a consultation for MSKP at one of 
the participating physiotherapy departments are eligible to participate.   
 

 
 
Table 1. Randomised controlled trial inclusion & exclusion criteria 
Inclusion criteria 
 Patients who, via telephone or online text-based triage, are judged to have 
benign MSKP and are booked for an initial physiotherapy consultation 
 Adult patients (18 years or older) 
Exclusion criteria 
 Patients who are judged to require urgent medical examination due to 
suspected serious pathology (red flags) 
 Patients who are booked for an initial physiotherapy consultation on the 
same day as, or the day directly following triage 
 Patients referred for physiotherapy following consultation with a tertiary 
care practitioner (e.g. orthopaedic surgeon, rheumatologist, neurologist)  
 Patients who cannot communicate in Swedish to the equivalent of a 12-
year-old native speaker (as judged by the triaging physiotherapist) 
 Patients who, through visual impairments, are unable to complete the 
necessary questionnaires for the study 
 Patients who are booked for an initial consultation with a physiotherapist 
who has not consented to taking part in the study 
 
 
Figure 1: CONSORT flow chart of participants’ path through the study. PROMS, patient 
reported outcome measures, PREMs, patient and physiotherapist reported experience 
measures.  

 
 
Intervention description and rationale 
The intervention in this study is the PainSMART-strategy as an adjunct to usual 
physiotherapy care and is described according to the Template for Intervention Description 
and Replication (TIDieR; Hoffmann et al., 2014).  
The PainSMART-strategy is a two-stage intervention. Stage one consists of the administration 
of an educational film and reflection and reinforcement of the film’s key messages prior to the 
initial physiotherapy consultation. The educational film is entitled ‘Be PainSMART:er’ and 
will be hereafter named simply as the film. Stage two is a discussion based on the film at the 
initial physiotherapy consultation. For details of usual physiotherapy MSKP management see 
the information relating to the control group. 
What 
Stage one: The film was produced and tested by the PainSMART-research group during 2022. 
The format and content of the film are based on qualitative interview pilot studies (March-
April 2022) with patients seeking primary care physiotherapy for MSKP (n = 10) and primary 
care practitioners (n = 9) (physiotherapists, occupational therapists, physicians and nurses) 
(Barkman, 2022; Stjärnskog, 2022). The results of these two studies were combined with 
cognitive science theories to produce a design framework for the film (Öhman, 2022). The 
PainSMART-research group then combined the design framework and the results of the two 
interview studies with modern pain theories, such as the predictive processing theory, Grand 
Poobah Pain Theory and the CSM, to generate the film’s manuscript and guide the film’s 
production (Caneiro et al., 2020; Kiverstein et al. 2022; Leventhal et al., 2016; Moseley & 
Vlayean, 2015; Moseley & Butler, 2017). The film was produced in the period of June-
August 2022 (Miltton Ltd, Sweden, 2022). The film was then pilot tested (September-
November 2022) with patients seeking primary care physiotherapy for MSKP (n = 10) and 
primary care practitioners (n = 13; physiotherapists, occupational therapists, physicians and 
nurses) to ensure its key messages were comprehensible and that the film addressed relevant 
targets (Johansson et al., 2022; Karlén & Lindgren, 2022). Following these pilot studies minor 
edits were made to the film.  
The film shows a dialog between a physician and a patient with MSKP. The film is seven 
minutes long and divided into three sections. Section one (4 minutes 30 secs) presents the idea 
that MSKP is a complex and necessary biopsychosocial protective system that does not 
accurately reflect the anatomical state of the body (Moseley & Butler, 2017). Section one also 
provides reassurance that MSKP is very rarely caused by serious pathology (Finucane et al. 
2020). Section two (1 minute 30 secs) provides advice on active coping strategies, such as 
encouraging exercise and work despite some pain, in an attempt to reconceptualise the 
commonly held belief that a painful body part needs to be rested (Caneiro et al., 2020; 
Setchell et al., 2017). Section three (50 secs) aims to prepare patients for their initial 
physiotherapy consultation by encouraging them to reflect on the time when their MSKP first 
developed and their overall life situation with the aim of facilitating a more biopsychosocial 
consultation. Following the film the patients will rate eight statements that summarise the 
film’s key-messages as listed in Table 2.   
The film aims to target patients’ impeding MSKP illness perceptions, improve pain self-
efficacy and encourage adaptive self-management strategies, all factors that are hypothesised 
to improve pain intensity over time. This requires the content of the film to improve factors 
such as maladaptive perceptions of the causes of MSKP and its persistence (for example, low 
outcome expectation, anxiety, catastrophizing, and fear avoidance beliefs) and low pain self-
efficacy. The content of the film addresses all the dimensions of the CSM and this is outlined 
in Table 2 (Leventhal et al., 2016).  

 
 
Stage two: The consulting physiotherapist will, via four structured questions, initiate a 
discussion about the film’s contents and the questionnaires the patient has completed prior to 
the initial consultation. The four questions ask the patient if any of the content within the 
questionnaires they have completed have generated any thoughts or reflections, whether they 
had actually seen the film, whether the film generated any thoughts or reflections and if there 
was anything in particular they took from the film. It is hoped that these questions, in addition 
to the film providing a shared basis for patient-centred MSKP communication, will facilitate a 
higher value initial consultation (Epstein et al., 2005; Lehman, 2017).  
Who 
All patients randomised to the intervention group (PainSMART) will receive the 
PainSMART-strategy as an adjunct to usual physiotherapy management. The physiotherapists 
who discuss the film at the initial physiotherapy consultation are all registered 
physiotherapists employed at one of the five participating physiotherapy departments (n = 
approx. 130). All participating physiotherapists will have seen the film and received written 
and verbal information about the study, and their role in the study, prior to the start of patient 
recruitment. No incentives are provided to the physiotherapists to take part in the study.  
Table 2: Content in the film addressing the illness perception dimensions in the Common-
sense model of self-regulation (CSM) (Leventhal et al., 2016). 
CSM 
dimension 
Key messages presented within the film 
Identity 
 Pain doesn’t necessarily mean damage and pain is a protective 
system that is necessary and often helpful.  
Timeline 
 Pain can improve and change over time, irrespective of how 
long you have had your pain. Many pain problems resolve by 
themselves, but it can take time.  
Consequences 
 Pain does not need to stop you from working, exercising or 
taking part in valued activities. But it can signal that you need 
to make some adjustments in your life. 
Causes 
 Pain is very rarely caused by serious pathology. 
 Pain is not always caused by injury. Pain can also be caused by 
physical overload, inactivity, imbalance in life or a combination 
of these factors. 
Control  
 You can influence your pain through your thoughts and actions 
but support is available from healthcare professionals. 
 You can act to improve your pain by staying active, adjusting 
sleep and diet if necessary. 
Emotional 
representations  
 Your thoughts and feelings towards your pain and your mental 
health influence your pain experience. 
 

 
 
Where and how 
The intervention group will be exposed to the film on two occasions. Access to the film is 
imbedded within the intervention group’s online questionnaires and the film is first made 
available immediately following completion of baseline background and PROM data 
collection. Further exposure occurs at the data collection time point prior to the initial 
physiotherapy consultation. The time from baseline to the initial physiotherapy consultation 
will vary for each participating patient depending on clinical prioritisation and the 
accessibility of initial consultations at the participating physiotherapy departments. The film 
is hosted on RÖ’s Quick channel, viewable on any electronic device and is exclusively 
available to the intervention group via the questionnaires. In order to reduce the risk of 
contamination bias the film is not shareable or available via online searching.  
All participating physiotherapists will provide initial consultations to patients in both the 
intervention and control groups. For the intervention group the initial physiotherapy 
consultations will take place as usual with the addition of the discussion around the film and 
questionnaires. Any tailoring of the physiotherapists’ responses to the patients’ answers will 
occur according to the preferences and skills of each individual physiotherapist. The 
physiotherapists will not have access to the results of the questionnaires completed by the 
patients prior to the initial consultation.  
Why 
Stage one: The theoretical rationale for the film’s causal effects can be based on an integration 
of modern pain theories, the CSM and the concept of self-efficacy (Bandura, 1977; Leventhal 
et al., 2016; Kiverstein et al., 2022; Moseley & Butler, 2017). The film and patient’s 
reflections on the film’s key messages are hypothesised to have effect on patient health 
outcomes and be mediated by improved cognitive and emotional illness perceptions. The 
potential direct effects of the film on pain intensity can be linked to factors such as MSKP 
related concern which directly influences the individual’s perceived threat to bodily integrity 
(Kiverstein et al., 2022; Moseley & Butler, 2017). Self-efficacy and illness perceptions have 
been suggested in respective theoretical models to influence behaviour, including self-
management strategies, and thereby affect health outcomes. Individuals´ perceptions about 
their illness, such as how they perceive its causes and consequences, may influence their self-
efficacy. An integration of the CSM and concept of self-efficacy to explain health outcomes 
has been previously suggested (Breland et al., 2020; Lau-Walker, 2004). Figure 3 illustrates 
such an integration where illness perceptions are hypothesised to influence behaviour and 
health outcomes directly or indirectly through improved self-efficacy. Therefore, both MSKP 
illness perceptions and pain self-efficacy could act as mediators of the effects of the 
PainSMART-strategy. Improvement in an individual's MSKP illness perceptions and 
reassurance as to the benign nature of MSKP may improve pain self-efficacy which may in 
turn change behaviour and affect health outcomes, such as reduced pain intensity, increased 
levels of physical activity and reduced sick leave. 
Stage two: The rationale for discussing the film at the initial physiotherapy consultation can 
be based on reinforcing the mechanisms of effect described in stage one, encouraging 
adherence to the viewing of the film and on the film’s aims to facilitate the initial 
consultation. All participating physiotherapists will have seen the film prior to the start of 
patient recruitment, and this enables the physiotherapists to build on and reinforce the film’s 
key messages (Table 2). As the film is administered prior to the initial physiotherapy 
consultation it can prepare patients for their consultation and potentially make the patients 
more central to the process of MSKP-related conceptual change (Moseley & Butler, 2017). A 
discussion between the patient and physiotherapist about the film and aspects salient to the 

 
 
individual patient aims to facilitate a more biopsychosocial consultation, enhance patient 
participation in their care and improve shared understanding and communication around 
MSKP (Lehman, 2017). 
Adherence promotion and monitoring  
Patients randomised to the intervention group will rate eight statements about the clarity of 
the film’s key messages following first exposure (at baseline) and be asked how many times 
they have viewed the film (out of a maximum of two) as part of the data collection prior to the 
initial physiotherapy consultation. Patients randomised to the intervention group will be 
informed that they will discuss the film with the physiotherapist at their initial consultation to 
improve adherence. Non-responders to the questionnaires will receive short messaging service 
(SMS) and telephone reminders to improve adherence to the intervention.  
All physiotherapists who have conducted at least one of the approximately 490 initial 
physiotherapy consultations during the RCT will subsequently be asked to complete a 
questionnaire. This questionnaire asks the physiotherapists to anonymously rate whether they 
adhered to the study protocol by posing the structured PainSMART-questions to participating 
patients in the film (four questions) and control (one question) groups respectively. 
Physiotherapist’s adherence to the protocol for the final 30 to 40 consultations (qualitative 
phase) will be further verified via the transcriptions.  
Control condition: Usual physiotherapy management alone  
Patients first contact their physiotherapy department via telephone or online text-based service 
and are triaged by a certified physiotherapist. During triage the patients may receive some 
tailored or generalised advice regarding their presenting condition and possible management 
strategies or simple exercises. Following triage, the usual management group will receive 
online data collection questionnaires identical to those of the intervention group apart from 
the film and the questions directly related to the film. The initial physiotherapy consultation 
will take place as usual according to the preferences of the physiotherapist with the addition 
of one question asking the patient to reflect on the questionnaires they have completed as part 
of the study.  
Concomitant care  
No limitations will be placed on patients in either group regarding their access to other 
educational materials, medical advice or treatments during the study. Patients will self-report 
at baseline previous healthcare consultations that they have attended for their presenting 
MSKP complaint or other MSKP complaints in the three months prior to baseline. The 
patients will also self-report additional healthcare consultations for their presenting MSKP 
during the study at 24-72 hours prior to the initial physiotherapy consultation, 24 hours post 
initial physiotherapy consultation and again at three months post-baseline. Additional 
information about healthcare consultations that have occurred during the study period 
(baseline to three months) for MSKP complaints will be collected from RÖ’s and RJL’s data 
registers after the completion of PROM and PREM data collection for all participants.   
 

 
 
Figure 3: The Common-sense model of self-regulation with integration of the concept of self-
efficacy. The figure is modified from Fors (2023). 
Outcomes  
The outcomes chosen for this study reflect its aims and theoretical underpinnings.  
To aid the selection of PROMs and evaluation of potential PROMs’ psychometric properties, 
the COSMIN (COnsensus-based Standards for the selection of health Measurement 
INstruments) database was searched on the 22nd of February 2023 for systematic reviews 
evaluating potentially relevant PROMs. Two patient co-designers educated in research 
methods were also involved in the final choice of study outcome measures in order to 
incorporate a patient perspective (Mercieca-Bebber et al., 2018).  
Demographic data 
Patient participants: Basic demographic data of age, sex, height and weight will be collected 
at baseline. Key baseline covariate factors to be collected at baseline are pain duration, pain 
location for the actual presenting MSKP complaint, number of other sites with MSKP, 
previous health care interventions for presenting MSKP complaint in the last 3 months, 
previous health care interventions for other MSKP sites in the last 3 months, number of co-
morbidities, analgesic medication use (type and consumption), level of education, 
employment and self-reported sick leave for the presenting MSKP complaint.  
Physiotherapist participants: Basic demographic data of age, sex, department, level of 
education and number of years working as a physiotherapist will be collected prior to the start 
of patient recruitment.  

 
 
Patient Reported Outcome Measures (PROMs) 
For information on the time points for data collection of each PROM and PREM see patient 
participant timeline and Figure 4.  
Primary outcome measures  
Both primary outcome measures will be collected and analysed via group mean change from 
baseline. Primary outcome analysis time points are 1) Baseline to 24 hours post initial 
physiotherapy consultation and 2) Baseline to three months.   
- 
Pain intensity  
Pain intensity is chosen as a primary outcome for this study as it is a core outcome measure 
for intervention studies on pain (Chiarotto et al., 2018). Average pain intensity in the previous 
24 hours will be measured using a numerical rating scale (NRS) (0-11 from 0 = no pain to 10 
= worst imaginable pain) (Jensen et al., 1999). The average pain intensity NRS rating related 
to the past 24 hours has been chosen to reduce overlap of the ratings at the separate data 
collection time points. Consensus from the VIII International Forum on Primary Care 
Research on LBP and the median of study results from systematic reviews of pain intensity 
ratings in acute and chronic pain suggests that the minimal clinically important difference 
(MCID) for pain intensity is two points (Olsen et al., 2017; Olsen et al., 2018; Ostelo et al., 
2008).  
- 
Pain self-efficacy  
The second primary outcome in this study is pain self-efficacy. Pain self-efficacy is defined as 
“a belief in one’s ability to carry out activities even when in pain” (Nicholas et al., 2015, p. 
153). Pain self-efficacy will be measured using the PSEQ-10 (Nicholas, 2007). The PSEQ-10 
is a ten-item scale scored as a total (0-60). The PSEQ-10 includes ten statements where 
participants are asked to rate, from zero to six, how confident they are that they can do certain 
things despite their pain (Nicholas, 2007). The PSEQ is grounded in Bandura’s concept of 
self-efficacy and has been frequently used in MSKP research (Dube et al., 2021; Nicholas, 
2007). The PSEQ-10 was judged to have good content validity, structural validity, test-retest 
reliability and responsiveness whilst its internal consistency was judged as excellent in the 
COSMIN guided systematic review conducted by Dube et al. (2021). Furthermore, the PSEQ 
was recommended as the most appropriate PROM for measuring pain self-efficacy in Sleijser-
Koehorst et al.’s Delphi-study (2019). The PSEQ-10 has been cross-culturally adapted to 
Danish in a chronic LBP population and a Swedish cross-cultural adaptation of the PSEQ-2 in 
a MSKP population has been recently published (Ekhammar et al., 2024; Vejlgaard et al., 
2021). The MCID for the PSEQ-10 has previously been cited to range from 5.5-8.5 (Dube et 
al., 2021). The PSEQ-10’s standard error of the mean (SEM) has been cited to range from 
1.23 to 5.66 and the minimal detectable change cited as 11.52 (Dube et al., 2021). Pain self-
efficacy has been chosen as a primary outcome in this study as it has the potential to change 
rapidly in response to an educational intervention, is thought to mediate the relationship 
between pain and disability and because higher pain self-efficacy is thought to be protective 
of the development of chronic MSKP (Lee et al., 2015; Martinez-Calderon et al., 2018; Miles 
et al., 2011). 
Secondary outcome measures 
- 
Secondary outcome PROMs 
Secondary outcome measure PROMs will be collected and analysed as mean aggregate 
change from baseline to 24-72 hours prior to the initial physiotherapy consultation, 24 hours 

 
 
post-initial physiotherapy consultation and at three months post-baseline. Between group 
differences in changes over time will also be analysed.  
- 
Secondary analyses of primary outcome measures 
NRS pain intensity and pain self-efficacy will be additionally analysed as secondary outcomes 
for within group and between group differences for data collected at non-primary outcome 
time points. In addition to the primary outcome of average pain intensity, worst pain intensity 
and best pain intensity in the previous 24 hours will be measured using two NRS scales (0-11 
from 0 = no pain to 10 = worst imaginable pain) (Jensen et al., 1999). Both primary outcome 
measures will be additionally analysed as a secondary outcome for proportion of responders 
based on study specific MCIDs. The MCIDs for the two primary outcomes will be calculated 
for interpretation of the within and between-group differences. The MCIDs will be calculated 
for the whole cohort using an anchor method based on the Global rating of change scale 
(GRoCs) scores (Revicki et al, 2008). 
- 
MSKP illness perceptions 
MSKP illness perceptions will be measured using the Brief Illness Perception Questionnaire 
(BIPQ; Broadbent et al., 2006). Illness perceptions are defined in this study as “the mental 
representations and personal ideas that people have about an illness” (Broadbent et al., 2015, 
p. 1362). The BIPQ was developed based on the CSM to provide a simple and quick 
assessment of illness representations, emotional representations and illness comprehensibility 
(Broadbent et al., 2015). The BIPQ contains nine questions, eight use an eleven-point 
numerical rating scale with anchor statements whilst the final question is a free text question 
asking participants to list the three most important factors that they believe caused their 
MSKP (Broadbent et al., 2006). The BIPQ covers the following constructs; cognitive illness 
representations (consequences, timeline, personal control, treatment control and identity), 
emotional representations (concerns and emotions), illness comprehensibility and causes 
(Broadbent et al., 2006). The BIPQ will be analysed as a total score (out of 80) according to 
the scoring instructions from Broadbent et al. (2015). The total score gives an impression of 
the participant’s perception of the threat or benign nature of their MSKP, with a higher score 
reflecting a higher threat (Broadbent et al., 2015). For the intervention group only, the BIPQ 
will be repeated directly after first exposure to the film and questions related to the film’s key 
messages to assess any immediate change in MSKP illness perceptions. The causal item 
question will be collected at baseline, directly following first exposure to the intervention, 24-
72 hours prior to the initial physiotherapy consultation and again 24 hours after the initial 
consultation. The BIPQ has been widely used in MSKP research, is validated in Swedish and 
Norwegian and has shown good concurrent and predictive validity, sensitivity to change and 
test-retest reliability on meta-analysis (Broadbent et al., 2015; Emilsson et al., 2020; Løchting 
et al., 2013). MSKP illness perceptions are chosen as a secondary outcome in this study as 
they have the potential to change rapidly in response to an educational intervention, can 
mediate the effects of the PainSMART-strategy and as evidence suggests that more negative 
MSKP illness perceptions are associated with higher pain intensity and poorer physical 
function (De Raaij et al., 2018).  
- 
Level of reassurance as to the benign nature of MSKP 
Self-reported level of reassurance of the benign nature of MSKP will be measured using a 
single reassurance NRS with an eleven-point scale. This question asks the patient how 
reassured they are that there is not a serious condition causing their MSKP. This question has 
been adapted from the original research by Sox et al. (1981) and has been previously used in 
research on acute LBP (Deyo et al., 1987). For the intervention group only, the reassurance 

 
 
NRS will be repeated directly after first exposure to the film and questions related to the 
film’s key messages to assess any immediate change in reassurance. Reassurance is an 
important measure of the PainSMART-strategy’s effects as the overall level of threat ascribed 
to a MSKP condition has been linked to pain intensity, disability and pain behaviours (Lee et 
al., 2015; Leventhal et al, 2016: Moseley & Butler, 2017).  
- 
Pain coping strategies and psychological flexibility 
Traditional MSKP coping strategies and psychological flexibility will be measured using the 
Brief Pain Coping Inventory 2 (BPCI-2; Vowles et al., 2014). The BPCI-2 is a 19-item 
questionnaire, where participants are asked to report on how many days during the last week, 
they adopted certain pain management strategies (0-7 days). The BPCI-2 contains two sub-
scales measuring traditional pain coping strategies and psychological flexibility (Vowles et 
al., 2014). Psychological flexibility is defined as “one’s ability to directly and openly contact 
experiences in the present moment and persisting or changing behaviour according to what 
the situation affords and one’s personal goals and values” (Vowles & McCracken, 2010 p. 
141). Higher total (0-105), or subscale scores (0-56 for traditional MSKP coping strategies 
and 0-49 for psychological flexibility; four reverse-scored items) on the BPCI-2 indicate more 
adaptive coping (Vowles et al., 2014). The BPCI-2 is based on the Acceptance and 
Commitment therapy model and has been developed and validated in chronic MSKP 
populations (Vowles et al., 2014). The majority of experts who knew of the BPCI-2 in 
Sleijser-Koehorst et al.’s (2019) Delphi study recommended its use. However, the BPCI-2 had 
not been validated in Swedish or in a primary care population. As such the PainSMART-
research group has conducted (May-December 2023) a cross-cultural adaptation and 
validation of the BPCI-2 in a population of patients seeking primary care physiotherapy for 
MSKP (Bowling, 2004: Mokkink et al., 2019). Provisional results from this study indicate 
that the BPCI-2 has acceptable psychometric properties in this population. The BPCI-2 has 
been chosen as an outcome measure in this study as coping is included in the CSM, passive 
coping strategies are a risk factor for the development of chronic pain and because 
psychological flexibility has been found to be significantly associated with pain intensity, 
physical functioning and psychosocial disability (Caneiro et al., 2020; Vowles et al., 2014).  
- 
Global rating of change 
Self-reported global rating of change will be measured using a single item Global rating of 
change scale (GRoCs) scored on an eleven-point scale. The eleven-point scale is scored from 
minus five to plus five, anchored by the terms very much worse (minus 5), unchanged (0) and 
completely recovered (plus 5) in accordance with the recommendation made by Kamper et al. 
(2009). The score is based on the period from when the patient first contacted the 
physiotherapy department to the GRoCs data collection time points. GRoCs are widely used 
in MSKP research and despite being vulnerable to recall bias, have good face and construct 
validity, test-retest reliability and good sensitivity to change (Kamper et al., 2009). GRoCs 
have been recommended as a core outcome measure for MSKP research as they are sensitive 
to patients’ priorities and are flexible to diverse conditions or pain sites, all factors pertinent to 
this study (Kamper et al., 2009). The GRoCs is also included in this study as an anchor for 
calculation of study specific MCIDs and analysis of the ÖMPSQ’s predictive ability.  
- 
Physical activity levels 
Levels of physical activity will be collected via three self-report screening questions 
developed for the Swedish national board of health and welfare (Kallings, 2014; Olsson et al., 
2016). These three questions ask the patients how many minutes in the last week they have 
performed exercise that makes them breathless, how many minutes they have been otherwise 

 
 
physically active besides exercise, for example doing housework or gardening, and how many 
hours they usually sit during a day (not including sleeping). From these questions it can also 
be calculated if patients attain a threshold of at least 150 mins per week of moderate intensity 
physical activity. These questions are included as a secondary outcome measure as the 
PainSMART-strategy aims to impart the message that maintaining physical activity, even 
whilst in pain, is important (Caneiro et al., 2022).  
- 
Self-reported analgesic use 
Self-reported analgesic medication use (type and level of consumption) for the presenting 
MSKP complaint will be collected via two questions. The first question establishes analgesic 
consumption with three response options: 1. Yes, on a regular basis; 2. Yes, sometimes; or 3. 
No. The second question establishes the type of analgesic consumption via six response 
options: 1. Paracetamol, 2. NSAIDs, 3. Opioids, 4. Gabapentinoids/Tricyclic 
antidepressants/Serotonin-norepinephrine reuptake inhibitors, 5. Don’t know, 6. Other (with 
free text answer).  
- 
Self-reported sick leave 
Patients will self-report if they are currently on sick leave for their presenting MSKP 
complaint at baseline, 24-72 hours prior to their initial physiotherapy consultation, 24 hours 
post-initial consultation and three months post-baseline. Self-reported current sick leave for 
the presenting MSKP complaint will be collected via one question with the response 
alternatives: Yes or No.  
- 
Self-reported healthcare visits 
Self-reported healthcare visits for the presenting MSKP complaint or other MSKP complaints 
will be collected at baseline relating to the three months prior to baseline. At all other data 
collection time points, additional healthcare visits for the presenting MSKP complaint will be 
self-reported. Additional healthcare visits (aside from the study physiotherapist) will be self-
reported as yes/no and for which professions the patient has consulted (five options; 1. 
Physician, 2. Nurse, 3. Another physiotherapist, 4. Chiropractor/Naprapath, 5. 
Councillor/psychotherapist).  
- 
Healthcare register data 
Data on participating patient’s healthcare consumption, sick leave days, referral for diagnostic 
imaging and referral to specialist/tertiary care for MSKP during the study period (from 
baseline to three months) will be collected from RÖ’s and RJL’s healthcare data registers and 
the national social security database (Försäkringskassan) following completion of all PROMs 
and PREMs data collection.  
Direct healthcare costs for MSKP per patient during the three-month study period will be 
collected (Sveriges Kommuner of Regioner, 2020). For all healthcare register data, a 
comparison will be made between the intervention and control groups to establish if the 
PainSMART-strategy can improve health outcomes and the effectiveness of the 
physiotherapy management pathway. 
- 
Screening tool 
The short form of the Örebro musculoskeletal pain screening questionnaire (ÖMPSQ) will be 
collected at baseline (Linton et al., 2011). The ÖMPSQ is a ten-item questionnaire which 
assesses five constructs; self-perceived function, pain experience, distress, fear-avoidance 
beliefs and return to work expectancy (Linton et al., 2011). The ÖMPSQ was developed in a 

 
 
primary care setting and the questionnaire is scored from 0-100 where a higher score indicates 
higher risk for future work-related disability (Linton et al., 2011). However, the predictive 
ability of the ÖMPSQ remains uncertain (Silva et al., 2022). The ÖMPSQ is included in this 
study to evaluate whether a certain sub-group of patients, based on ÖMPSQ scores, respond 
to the PainSMART-strategy.  
Patient and Physiotherapist Reported Experience Measures (PREMs) 
In this study PREMs will be collected after the film for the intervention group only, and 24 
hours after the initial physiotherapy consultation for both groups. The questions posed to the 
physiotherapists regarding their perception of the participating patients’ degree of preparation 
for their initial consultations will be collected following completion of the initial consultations 
in the RCT.  
- 
Evaluation of the intervention group’s experiences of the film 
The intervention group will rate the clarity of the key-messages in the film (Table 2) on a 
numerical rating scale of zero to ten anchored by the terms, not at all clear and completely 
clear. These questions are obligatory to increase adherence, reinforce the film’s key-messages 
and to assess whether the patients receiving the intervention pick up on the film’s intended 
messages.  
- 
Evaluation of MSKP-related shared understanding, communication, participation, 
involvement and emotional support at the initial physiotherapy consultation  
To examine the effects of the PainSMART-strategy on the initial physiotherapy consultation 
the patients will answer seven questions and the physiotherapists answer three questions in the 
approximately 24 hours following the initial consultation. Both the physiotherapists and the 
patients will complete PREMs in order to capture the patient perspective, physiotherapist 
perspective and to evaluate the interaction, as recommended by Epstein et al. (2005). The 
PREMs collected in this study are questions adapted from the Swedish National Patient 
Survey (Nationell Patientenkät, 2015). The National Patient Survey questions are based on 
validated and reliable instruments and the questions have been adjusted and translated to suit 
the Swedish healthcare system (Nationell Patientenkät, 2015). The questions the patients will 
answer cover four dimensions; namely shared understanding of the patients MSKP, 
participation and involvement, exchange of information and knowledge (communication) and 
emotional support (Nationell Patientenkät, 2015). The seven questions evaluate if the patients 
felt that they had the possibility to talk sufficiently about their MSKP, whether they felt 
included in decision making around their care, whether they had the opportunity to discuss 
any worries or concerns they had regarding their MSKP and to what extent they discussed 
what they themselves could do to improve their MSKP and health. The patients will also be 
asked if they felt they could reach a consensus in understanding with the physiotherapist 
regarding their MSKP, if they felt the physiotherapist considered their personal MSKP 
experiences and explained MSKP in a way that they could understand. The physiotherapists 
in turn will answer three questions rating whether they felt they received sufficient 
information from the patient to adequately make clinical judgements regarding the patient’s 
MSKP, whether they and the patient could reach a consensus regarding the patient’s MSKP 
and whether they felt the patient actively took part in decision making regarding their care. 
Both the patients’ and physiotherapists’ questions are answered via an eleven-point NRS with 
anchor statements. A higher score on individual items or total scores indicates a more positive 
evaluation. These questions have been chosen as they allow evaluation of the patients’ and 
physiotherapists’ experiences of shared understanding, communication, involvement and 
support rather than satisfaction as satisfaction levels are known to be biased to patients’ 
expectations (Nationell Patientenkät, 2015). These questions are included in the study as the 

 
 
dimensions they cover are central to a high-quality consultation (Epstein et al., 2005; Lehman, 
2017).  
- 
Evaluation of physiotherapists’ perception of the degree to which the participating 
patients in the respective groups are prepared for their initial physiotherapy consultation 
All physiotherapists who have conducted at least one of the approximately 490 initial 
physiotherapy consultations in the RCT will anonymously rate, on a scale from zero to ten, to 
what extent they felt that the patients in the film respective control groups were prepared for 
their initial consultation (i.e. to what extent the patient seemed to have reflected over 
biopsychosocial factors that may have influenced their pain experience and its impact on 
function and wellbeing prior to the initial consultation). These follow up questions are aimed 
at evaluating the consulting physiotherapists’ impression of the impact of the film and 
questionnaires on the participating patients’ degree of biopsychosocial understanding of 
MSKP at their initial consultations.  
- 
Qualitative evaluation of the effects of the PainSMART-strategy on communication at the 
initial physiotherapy consultation 
The PainSMART-strategy is a complex intervention in which the potential mechanisms of 
effect are diverse (Lewin et al, 2009). The quantitative part of the RCT will provide limited 
insight into how the PainSMART-strategy directly influences patient-physiotherapist 
communication at the initial physiotherapy consultation. Therefore, to further analyse the 
effects of the PainSMART-strategy on the initial consultation the concluding phase of the 
RCT will include a qualitative data collection.   
The qualitative phase of the RCT will be based on naturally occurring audio data from the 
initial physiotherapy consultations of the final 30 to 40 RCT patient participants. All 
physiotherapists who have conducted at least one of the first 450 initial consultations in the 
RCT will be asked for additional consent to audio record their consultations with the final 
group of participating patients. Naturally occurring data has been chosen as the preferred 
method of data collection for the qualitative phase as it enables an analysis of the 
PainSMART-strategy that closely mirrors its proposed implementation (Silverman, 2022). 
This data collection method also enables anonymous data analysis which can reduce the risk 
of the participating physiotherapists adjusting their consultations in the presence of an 
observing member of the research team. In addition to the audio recordings these final 30 to 
40 patient participants in the RCT will follow the same recruitment strategy, randomisation 
process (15-20 participants per group) and patient participant timeline for data collection as 
all other included patient participants (Figure 4). As per protocol, the participating 
physiotherapists will evaluate the consultation via three questions and subsequently rate to 
what extent they felt the patient participants were prepared for their initial consultation.  
Patient participant timeline 
Questionnaires will be sent to each patient participant at the following time points: 
1. Baseline: the same day as initial triage. 
2. 72-24 hours prior to the initial physiotherapy consultation. 
3. 24 hours post initial physiotherapy consultation. 
4. Three months post-baseline. 
For details of what data is collected at each time point see Figure 4. 

 
 
All patient participants will be enrolled via the standard access pathways to the participating 
physiotherapy departments in RÖ and RJL. All patient participant data will be collected using 
the Webropol online questionnaire management service (Linköping, Sweden). For those 
patients who consent to be contacted by the study coordinators, a SMS-link to the baseline 
questionnaires will be sent the same day as the initial triage (Time point 1). The baseline 
questionnaires contain more extensive information about the study and the possibility to 
provide definitive consent. Patients that consent then obtain access to and complete the 
baseline demographic data and PROMs questionnaires (Time point 1). For patients 
randomised to the intervention group the film is included at the end of the baseline 
questionnaire, followed by the questions regarding the film’s key-messages plus a repeat of 
the BIPQ and reassurance NRS. Both groups will then receive follow-up PROMs 
questionnaires approximately 72-24 hours prior to the initial physiotherapy consultation 
(Time point 2) and again 24 hours after the initial physiotherapy consultation (Time point 3). 
PREMs data will be collected at time point three. The final data collection will occur three 
months after each patient’s inception to the study (Time point 4).  
Physiotherapist data collection 
Physiotherapist consent and background data will be collected via Webropol questionnaires 
prior to the start of patient recruitment. English language copies of the data collection 
questionnaires (patient and physiotherapist PROMs and PREMs) are available from the 
corresponding author on request. The physiotherapists’ evaluations of the initial consultation 
will be sent to the study coordinators via the messenger function of the electronic journal 
system within RÖ and RJL. All physiotherapists who have conducted at least one initial 
PainSMART consultation in the RCT will be sent a follow up Webropol questionnaire 
containing four questions. These four questions ask the physiotherapists to self-report their 
adherence to the study protocol for each group and rate their experiences of the participating 
patients’ degree of preparedness for the initial consultations. For physiotherapists who 
consent to continue participation in the RCT for the qualitative phase, additional data will be 
collected via Dictaphone audio recordings of the initial physiotherapy consultation. The audio 
recordings will then be uploaded to Linköping University’s secure NextCloud service.  
Sample size 
The sample size calculation for this study is based on its primary hypotheses. The calculations 
are based on the MCID of 2±SD4 for the NRS for pain intensity and a minimal detectable 
change of 11.52±SD23.20 for the PSEQ-10 (Dube et al, 2021; Olsen et al., 2017; Olsen et al., 
2018; Ostelo et al., 2008). Sample size calculations were computed for both primary 
outcomes (NRS and PSEQ-10) using a Cohen's f effect size of = 0.25 (i.e. small-moderate) 
and a one-sided p-value of p=0.05 plus a statistical strength of 0.8 (=Power 80%). The largest 
sample size calculated was for analysis of the NRS (n = 102 per group) and this was adopted 
as the sample size for this study. To enable mediation and sub-group analyses two subgroups 
are required. This gives a total sample size of 408 patients. A drop-out rate of approximately 
30% was factored into the randomisation sequence giving a total sample of 600 patients. 
After the first six weeks of patient recruitment (January-February 2024) an internal pilot 
interim analysis was performed. Of the patient participants who expressed an interest in 
participating in the study, 65% actually consented and completed baseline data collection. As 
of February 29th, 2024, response rates for the questionnaires at time points two and three were 
approximately 90%. To ensure sufficient follow up data for 408 patients, the number of 
patients to be included at baseline was revised up to 450. This revision, along with the 
requirement to recruit 30 to 40 additional patients for the qualitative phase, led to a new total 

 
 
sample size of 490 patients. As a result of the revised sample size an additional randomisation 
sequence of 200 further patient participants was generated (see allocation).  
Sample size for the qualitative phase 
Inclusion of an additional 30 to 40 patient participants was chosen to increase the probability 
of achieving saturation of qualitative data and diversity of patient and physiotherapist 
participants with varying baseline characteristics. 
 
 
Figure 4: PainSMART-RCT Directed acyclic graph (DAG) showing data collection time points and 
data collected at each time point. BIPQ, Brief Illness Perception Questionnaire; BPCI-2, Brief Pain 
Coping Inventory-2; NRS, Numerical Rating Scales; PSEQ-10, Pain Self-Efficacy Questionnaire; 
PROMS, patient reported outcome measures, PREMs, patient and physiotherapist reported experience 
measures; RCT, randomised controlled trial.  
Recruitment 
Patient participants will be recruited via the five participating primary care physiotherapy 
departments within RÖ and RJL. To access physiotherapy, patients contact their local 
rehabilitation or healthcare centre via telephone (TeleQ) or an online text-based service 
(1177-direkt) and are triaged by a certified physiotherapist. Eligibility for the study will be 
assessed by the triaging physiotherapist. Potentially eligible patients will be asked via 
standardised oral or text information for an initial consent to share their contact details with 
the study’s coordinators. For those patients who consent to be contacted, the study 
coordinators will send an SMS with a link to the baseline Webropol questionnaire that 
contains further information about the study and the possibility to provide definitive consent. 
SMS reminders will be sent to potential participants to encourage recruitment. One practicing 
physiotherapist has been appointed as a local PainSMART-champion at each of the 
participating physiotherapy departments. The PainSMART-champion's role is to facilitate 
patient recruitment, communication between the research team and the department and guide 

 
 
study design and implementation. The PainSMART-research group will, along with each 
PainSMART-champion, provide introductory information about the study prior to the start of 
patient recruitment. Ongoing communication between the research team and participating 
departments and their local champions will take place during the patient recruitment period to 
assist with the study and encourage recruitment. Members of the research team will make 
further visits to the participating departments as necessary during the study. No incentives are 
provided to encourage patient recruitment. Recruitment will continue until the sample size is 
met. Ongoing patient recruitment will be monitored by the study coordinators and is expected 
to take between six months to one year.  
Participating physiotherapists will be all certified physiotherapists employed at the five 
participating physiotherapy departments. The management team at all five participating 
departments have consented to the study and encourage all employed physiotherapists to 
consent to partake in the study.  
Recruitment to the qualitative phase 
Recruitment of new patient participants to the RCT was paused once 450 patient participants 
had consented and completed baseline data collection (May 21, 2024). The qualitative phase 
of the RCT will commence once all follow-up data collection has been completed for these 
450 participants (October 2024). Eligible patient participants for the qualitative phase are 
patients meeting the RCT’s inclusion criteria booked for an initial consultation with a 
participating physiotherapist. Recruitment will cease once 30 to 40 patients have attended 
their initial physiotherapy appointment and audio data has been collected.   
Allocation and sequence generation 
All patients who consent to share their contact details with the study coordinators will be 
randomised. The study coordinators will input all potential patient participants into the code-
key system that contains a computerised simple randomisation sequence for 800 patients into 
group A or B. Patients will therefore be randomly allocated to the intervention (A) or control 
group (B) based on the consecutive order of their inception to the study. The initial 
randomisation sequence of 600 patients was generated using SPSS by a blinded statistician 
prior to the start of patient recruitment (January 2024). Following the internal pilot interim 
analysis (February 29th, 2024) and the decision to add the qualitative phase to the RCT, the 
total sample size was revised upward to 490 patient participants (from 408). Due to the 
approximately 65% consent rate at baseline seen during the first month of the RCT, an 
additional simple randomisation sequence of 200 further patient participants was produced by 
a blinded statistician using SPSS. This gave a total randomisation sequence of 800 potential 
patient participants (600 + 200).  
Allocation concealment mechanism 
Only patients randomised to the intervention group will be provided access to the film (at time 
points 1 and 2). Patients randomised to the intervention group will receive the questionnaire 
battery that includes the film. The control group will receive an identical questionnaire battery 
aside from the inclusion of the film and questions relating to the film. No mention will be 
made of the existence of an educational film in the information provided to potential 
participants prior to the completion of baseline data collection. Only once patient participants 
have consented to the study and completed baseline data collection will the study coordinators 
document each patient’s participation and group allocation in the electronic journal system for 
the relevant physiotherapist. This process enables both the patients and treating 
physiotherapists to be concealed from group allocation during the recruitment phase, 
removing the risk of bias related to consecutive group allocation. 

 
 
Blinding 
All participating patients and physiotherapists are blinded to group allocation until after 
patient consent and baseline data collection. All patients will receive identical information and 
questionnaires until completion of baseline data collection. Only after completion of baseline 
data collection will the intervention group receive knowledge of, and access to, the film. The 
participants in the intervention group are therefore only blinded to the intervention until after 
the completion of baseline data collection. The participating physiotherapists will only receive 
knowledge of a patient’s group allocation after the patient has consented to the study. It is not 
possible to blind for an educational intervention and part of the intervention is aimed at 
facilitating the initial physiotherapy consultation. This necessitates the physiotherapist having 
knowledge of whether the patient has been allocated to the intervention or control group. 
Patients randomised to the control group will be blinded to the existence of an educational 
film. The study coordinators are not blinded to group allocation but have no role in the 
patients’ physiotherapy care. Data analysis for all outcomes collected from both study groups 
will be performed by researchers and an independent statistician blinded to group allocation. 
Data collection and management 
All participant data will be handled and processed by the research team responsible for the 
study. All participants will be pseudonymised via the use of a code-key system. All patient 
participant questionnaire data will be collected electronically via the Webropol system. 
Webropol data is hosted on a secure server within RÖ. Non-responders to the questionnaires 
will receive SMS and telephone reminders in order to reduce dropouts and missing data. At 
the conclusion of the study all Webropol data will be transferred to Linköping University’s 
secure server for analysis. In addition, physiotherapist background data will be collected via 
Webropol questionnaires and physiotherapy PREMs data via secure messages within RÖ’s 
and RJL’s electronic journal system. Reminders will be sent to the physiotherapists via the 
electronic journal system regarding the evaluation of the initial physiotherapy consultations. 
Physiotherapist initial consultation evaluation data will be stored pseudonymised via code-key 
on an excel-file and transferred to Linköping University’s server for analysis. The code-keys 
for patients and physiotherapists will be stored separately from the online data. Dictaphones 
will be used to record the initial physiotherapy consultations in the qualitative phase of the 
RCT. The audio files will be uploaded from the Dictaphones to Linköping University’s secure 
NextCloud service. Patients and physiotherapists will be anonymised during analysis of the 
audio recordings and transcripts of the recordings. Data management will comply with the 
European Union’s General Data Protection Regulation (GDPR). The information provided to 
potential participants will clearly state that their data will be handled and stored securely 
whilst analysis and reporting of results will be pseudonymised and at group level so that it is 
not possible to identify individuals. Secure data storage will continue throughout the study 
and for a minimum of ten years after its conclusion according to current Swedish legislation 
for research data (IMY, 2023). Only the research team will have access to the data in the 
study and will be responsible for data processing together with statistical support staff at 
Linköping University. 
Statistical methods  
This protocol outlines the principal features of the statistical analysis for this study. A full 
statistical analysis plan (SAP) has been published on Clinicaltrials.gov alongside this protocol 
and prior to the completion of patient recruitment (September 25, 2024). 

 
 
Participant characteristics 
Patient: Group characteristics will be presented using descriptive statistics. Baseline analysis 
between the intervention and control groups will be conducted to ensure the comparability of 
the groups. 
Physiotherapist participants: Group characteristics (age, sex, department, highest educational 
level, number of years of clinical experience, adherence to protocol) will be presented using 
descriptive statistics. 
Analysis of primary outcomes  
Magnitude of within and between-group change on primary outcomes from baseline to 24-72 
hours prior to the initial physiotherapy consultation, 24 hours post initial physiotherapy 
consultation and three months post-baseline will be analysed through mixed models. Data will 
be compared based on the ’intention to treat’ (ITT) principle. Sensitivity analyses applying 
per-protocol, complier average causal effect (CACE) analyses and analyses applying study 
specific MCID associated with dichotomised anchor response on the GRoC will be explored. 
Sensitivity analyses to adjust for all measured baseline covariates will also be performed to 
investigate the presence of equipoise as the result of randomisation (Thabane et al., 2013). 
Multiplicity/ type I (α) error 
The outcomes collected in the study are considered as separate entities and, therefore, 
restrictive multiplicity penalisation of the model is not required (Dmitrienko & D’Agostino 
2013). Adjustment will be used for repeated measures over time for separate test conditions. 
Analysis of secondary outcomes  
Magnitude of within and between-group change on secondary PROM outcomes from baseline 
to 24-72 hours prior to the initial physiotherapy consultation, 24 hours post initial 
physiotherapy consultation and three months post-baseline will be analysed through mixed 
models. The causal item question of the BIPQ will be analysed via the grouping of answers 
into categories, as recommended by Broadbent et al. (2015). Additional analysis will be 
conducted for the intervention group only for mean aggregate change in the BIPQ (item and 
total score) and reassurance NRS directly after the first exposure to stage one of the 
intervention. Data will be compared based on the ’intention to treat’ (ITT) principle. 
Sensitivity analyses applying per-protocol, complier average causal effect (CACE) analyses 
and analyses applying study specific MCID associated with dichotomised anchor response on 
the GRoC will be explored. Sensitivity analyses to adjust for all measured baseline covariates 
will also be performed to investigate the presence of equipoise as the result of randomisation 
(Thabane et al., 2013). 
Analysis of healthcare register outcomes  
Number of healthcare visits, referrals to diagnostic imaging and to specialist/tertiary care, sick 
leave days and direct healthcare costs from baseline to three months post-baseline will be 
analysed for both groups and between group differences analysed statistically using t-tests.  
Mediation analyses  
MSKP illness perceptions and level of reassurance as to the benign nature of MSKP are 
hypothesised, based on an integration of the CSM and concept of self-efficacy (Figure 3), to 
be potential mediators of the effect of the PainSMART-strategy on pain intensity as well as 
other secondary outcomes. The integrated model also hypothesises pain self-efficacy to be a 
mediator in a series of mediators of the PainSMART-strategy’s effects. The effect of MSKP 
illness perceptions and level of reassurance as to the benign nature of MSKP on pain self-

 
 
efficacy may act as a first step in the causal pathway of the PainSMART-strategy´s effect on 
health outcomes. Single causal mediation analysis will be used to analyse indirect effects on 
pain intensity (NRS) and pain self-efficacy (PSEQ-10) through improvement in MSKP illness 
perceptions (BIPQ) and reassurance (NRS). The direct acyclic graph model in Figure 5 
summarises these causal inferences. Identified potential confounders of the mediator–outcome 
relationship will be adjusted for in the single mediation analyses. The minimum sufficient 
adjustment set includes age, sex, BMI, pain duration, number of pain sites, comorbidity, 
employment, educational level, days to initial physiotherapy consultation, analgesic 
consumption and previous health care interventions. Analyses will also be adjusted for 
physiotherapist characteristics: age, sex, clinical experience and educational level.  
The mediation models will be estimated using path-analyses within the framework of 
Structural Equation Modelling (MacKinnon, 2012). The results will be reported according to 
A Guideline for Reporting Mediation Analyses (AGReMA; Lee et al., 2021). 
 
Figure 5. Directed Acyclic Graph (DAG) of the causal pathways for the effect of the PainSMART-
strategy on the outcomes pain intensity and pain self-efficacy via the hypothesised mediators and the 
estimated averaged effects adjusted for confounding effects. The potential confounders are measured 
at baseline. The indirect effect (ab-product) is the average intervention effect through the mediator. a, 
a-path (the intervention-mediator effect); b, b-path (the mediator-outcome effect); c, c-path (the total 
effect of the intervention on the outcome, without accounting for potential mediator); c´ (the direct 
effect of the intervention on the outcome, that works through all other mechanisms excluding the 
selected potential mediator). BIPQ, Brief Illness Perception Questionnaire; NRS, Numerical Rating 
Scale; PSEQ-10, Pain Self-Efficacy Questionnaire. 
Exploratory analyses  
Regression based statistics will be used to explore baseline predictors and mechanisms of 
longitudinal outcomes. Based on an integration of the CSM and concept of self-efficacy, the 
effect of MSKP illness perceptions and level of reassurance as to the benign nature of MSKP 
on pain self-efficacy act as a first step in the causal pathway of the PainSMART-strategy´s 
effect on health outcomes. As a second step in the causal pathway in the integrated model, the 

 
 
effect on pain self-efficacy is hypothesised to mediate the effects on health outcomes. A 
secondary objective is to explore if pain self-efficacy mediates the effect of the PainSMART-
strategy on health outcomes of interest. The mediation models will be estimated using path-
analyses within the framework of Structural Equation Modelling. 
Analysis of patient and physiotherapist experience outcomes (PREMs) 
The intervention group’s scores related to the clarity of the film’s key messages will be 
presented descriptively.  
Outcomes relating to the evaluations of the initial physiotherapy consultation will be analysed 
through descriptive statistics and between group differences for each question. Additional 
analysis will be conducted for concordance between the patients and physiotherapists ratings 
on the three paired questions for each group. 
Physiotherapists’ experiences of their perception of the participating patients’ preparedness 
for the initial consultation will be analysed through descriptive statistics and between group 
differences.  
Analysis of physiotherapist adherence  
Data on the physiotherapists’ self-reported adherence to the protocol will be cross-referenced 
with the film, respective control, group consultations each individual physiotherapist has 
conducted. This, in combination with the film group patients’ self-reported exposure to the 
film, will provide data indicating how many of the participating patients received the full 
PaintSMART-strategy. This data will enable per-protocol and CACE analyses.  
Analysis of qualitative outcomes  
The audio recordings of the initial physiotherapy consultations will be initially screened by a 
member of the PainSMART-research team. All audio data not considered relevant to the 
qualitative research questions, such as instructions on how to perform a certain exercise, will 
not be transcribed. To ensure anonymous analysis the screening will be conducted by a 
research team member ignorant to the identity of the participating patients and 
physiotherapists. Transcription will then be performed by an external party. The transcriptions 
will be analysed by PainSMART-researchers based on the realist thematic analysis (TA) 
method described by Wiltshire & Ronkainen (2021). This method has been selected as it 
enables an empirical analysis, identification and description of the study groups’ 
understanding and experiences of MSKP (Wiltshire & Ronkainen, 2021). A realist TA 
approach also enables inferences to be drawn on how unobserved mechanisms may influence 
the empirically observed experiential themes (Wiltshire & Ronkainen, 2021). This 
necessitates analysis by experts in MSKP and healthcare communication which, whilst risking 
a degree of analytical bias, can facilitate development of inferential and dispositional themes 
that are linked to the RCTs theoretical underpinnings (Leventhal et al., 2016; Moseley & 
Butler, 2017; Wiltshire & Ronkainen, 2021). These themes can in turn aid interpretation of 
the RCT’s quantitative results. To counter researcher bias, the validity of the experiential 
themes will be additionally analysed by at least one expert patient research partner involved in 
the RCT. Further qualitative analyses based on a deductive analysis method will be conducted 
to explore if the film’s key messages (Table 2) influence the physiotherapy consultation.  
Missing data  
Missing data will be analysed by comparing characteristics (average age, sex) of study 
participants with and without missing PROM data and analysing the impact of missing data 

 
 
on generalisability (Mercieca-Bebber et al., 2018). All outcome data will be compared based 
on the ITT principle. This means that all patients that have been randomised remain in the 
analysis based on their group allocation. In the event of substantial missing data, evaluation of 
the mechanisms for missing data will be used (Enders, 2011). Missing data will otherwise be 
handled under the missing at random assumption (Enders, 2011). Multiple Imputation or 
Maximum Likelihood estimation will be used assuming that missing data is conditional on 
variables included in the model. Imputation method considering missing at random or not 
missing at random will be used in the ITT analysis. Patients who cancel their initial 
physiotherapy consultation will be excluded from the PREM analysis but will remain in the 
study for PROM and healthcare register data analyses. 
Study monitoring and harms 
There will be no data monitoring committee since the study is independent from the sponsor 
and the intervention is implemented as an adjunct to usual physiotherapy management with 
low risk for unexpected adverse events. The PROMs included in the study are sensitive to 
worsening in the patients’ condition. An internal pilot interim analysis was planned and 
conducted (February 29th, 2024) after approximately 50% of the initially planned sample (n = 
229) had consented to the study and reported outcomes at time point two (72-24 hours prior to 
the initial physiotherapy consultation) and three (24 hours post the initial physiotherapy 
consultation). This interim analysis enabled evaluation of the viability of the a-priori sample 
size calculation and the recruitment frequency. The analysis utilised linear mixed models to 
investigate between group differences (effect size) for change from baseline to time points 
two and three for outcome. The significance level for the interim analysis was p=0.05. After 
interim sample size calculation, the sample size was adjusted slightly to take loss to follow-up 
into account. The sample size calculation is described under the protocol heading sample size. 
The trial would have been stopped if the internal pilot interim analysis could not be performed 
due to not attaining 50% of the sample size at Time point two and three within six months. No 
further interim analyses are planned. 
Ancillary and post-trial care 
All patient participants will follow the usual physiotherapy care pathway within RÖ and RJL 
and will therefore have access to other healthcare professions, resources and healthcare levels 
for additional consultation or management should any unexpected adverse event occur. There 
will be no restrictions placed on seeking other care during the trial period. Following 
completion of the study the patients will follow the usual management pathway.  
Ethics  
This study has been approved by the Swedish Ethical Review Authority 
(Etikprövningsmyndigheten). Diary number (Dnr): 2023-05968-01 (25/10/2023). An 
amendment to the initial ethical application outlining the concluding qualitative phase of the 
RCT and follow-up questionnaire for participating physiotherapists was submitted to the 
Swedish Ethical Review Authority on the July 1st, 2024. This amendment was approved on 
the July 21st, 2024 (Dnr: 2024-04524-02). 
Contact details: 
Swedish Ethical Review Authority, Box 2110, 750 02 Uppsala. 
Email: registrator@etikprovning.se. Telephone: +46104750800 

 
 
Consent  
Participant recruitment: All potentially eligible patient participants will receive standardised 
verbal or text information about the study from the triaging physiotherapist and be asked for 
consent to share their contact details with the study coordinators. If preliminary consent is 
obtained, then standardised information will be sent to potential participants via a SMS-link to 
a Webropol questionnaire. This information contains contact details to the study coordinators 
and those responsible for the study. Patients who provide consent will gain immediate access 
to the baseline questionnaire.  
Physiotherapist recruitment: All participating physiotherapists will provide definitive consent 
after receiving verbal information at workplace meetings and further written information in-
line with the patient participant recruitment. Consent will be collected via online Webropol 
questionnaires. Participation in the qualitative phase: all physiotherapists that have consented 
to the RCT and conducted at least one PainSMART-consultation prior to the start of the 
qualitative phase will be invited to continue their participation. The eligible physiotherapists 
will be informed about the qualitative phase by their local PainSMART champion and asked 
for verbal consent. 
Confidentiality  
The personal details of eligible patients will be shared with the study coordinators via the 
secure electronic journal system used within RÖ and RJL. All participants (patients and 
physiotherapists) will receive a unique code-key number to enable pseudonymisation of data 
and secure data storage within the Webropol system (RÖ) and SPPS program (Linköping’s 
University). The code-keys for the patient and physiotherapist participants will be stored 
separately from the secure Webropol (RÖ) server and Linköping’s University data analysis 
programs. The physiotherapists’ evaluations of the initial consultations will be stored 
pseudonymised by the use of a code-key. All results will be published at group level. All 
audio recordings will be deleted from Dictaphones immediately after being uploaded to the 
NextCloud service. Audio files in NextCloud will be uploaded into a separate file for each 
physiotherapy department and moved to a central PainSMART-file to remove access to the 
audio files for all but the research team responsible for the study.  
Declaration of interests  
No conflicting interests. To reduce bias, the study coordinators (RT & MF) will not treat any 
patients participating in the study in their roles as physiotherapists at the participating 
departments in Finspång and Linköping.  
Access to data 
Study data will only be accessible to the PainSMART-research group and statistical support 
team at Linköping’s University. Group level and individual patient data will be available from 
the research team on reasonable request following completion of the study and publication of 
the study results. 
Dissemination  
This study protocol was published via Clinicaltrials.gov to enable public access prior to the 
inception of patient recruitment. A full statistical analysis plan has been published on 
clinicaltrials.gov prior to completion of patient recruitment and start of data analysis. The 
study’s findings will be disseminated and made publicly available in peer-reviewed 
publications and conference presentations. The study’s results will also be disseminated 
through regular communication channels within healthcare and university contexts. If the 

 
 
results of the study are positive the film can be hosted on the 1177 healthcare information 
platform and be integrated into the primary care physiotherapy MSKP care pathway in RÖ 
and RJL and even across Sweden.  

 
 
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