The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy

Pain Clinical Trial

— PainSMART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187428
• Other study ID #: Dnr 2023-05968-01
• Secondary ID: Primary care reh
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Linkoeping University
• Contact: Richard Thompson, MSc
• Phone: +46793345083
• Email: richard.thompson[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the PainSMART-strategy in a population of patients seeking primary care physiotherapy for pain related to muscles, joints and bones, so called musculoskeletal pain. The PainSMART-strategy consists of a digital educational film (entitled Be PainSMART:er) and a discussion based on the film at the initial physiotherapy consultation. The main questions this clinical trial aims to answer are: 1. Can the PainSMART-strategy update knowledge and beliefs about pain and aid early stage self-management of pain for participants seeking primary care physiotherapy with benign musculoskeletal pain? 2. Can the PainSMART-strategy improve evaluations of the initial physiotherapy consultation for both the patient and physiotherapist? Participating patients will be randomised into two groups. One group (intervention group) will receive the PainSMART-strategy as an adjunct to the current physiotherapy care pathway for musculoskeletal pain. The other group (control group) will follow the current physiotherapy care pathway. The two groups will be followed and compared over three months. Self-report questionnaires will be collected during the three-month period to analyse what effects the PainSMART-strategy can have on the following health outcomes: - Pain levels - Beliefs that one can remain active despite pain - Knowledge about pain - Worry about the seriousness of the pain - Expectations regarding recovery - Use of pain self-management strategies - Levels of physical activity - Absence from work due to pain - Number of referrals made for scans or x-rays, or to a specialist, for pain - Number of healthcare visits for pain during the trial period. Participating patients (both groups) and physiotherapists will also complete questionnaires to evaluate the effect of the PainSMART-strategy on the initial physiotherapy consultation.

Description:

For more detailed information about the study see the attached study protocol

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 at one of the five participating physiotherapy departments
• 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 to 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

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain
• Communication
• Illness Perceptions
• Pain
• Pain Acute
• Pain, Chronic
• Patient-Centered Care
• Physical Activity Level
• Referral and Consultation
• Self Efficacy
• Sickness Absence
• Worry

Intervention

Other:
• PainSMART-strategy
Be PainSMART:er is a seven minute long film developed by the research group based on modern pain science and previous qualitative studies. The film is divided into three sections: Section 1- Educates that MSKP is a complex protective system that does not reflect the anatomical state of the body and provides reassurance that MSKP is rarely caused by serious pathology. Section 2- Provides advice on active MSKP coping, such as encouraging work despite some pain, in an attempt to reconceptualise the belief that a painful body part needs to be rested. Section 3- Aims to prepare patients for a biopsychosocial physiotherapy consultation by encouraging them to reflect on the film's messages. In addition to the film, the questions posed to the participant at the initial consultation aim to facilitate the discussion around the film and MSKP reflections. Management subsequent to the initial consultation will follow usual management.
• Usual physiotherapy management
Patients randomised to the control group follow usual MSKP physiotherapy management. Specifically, patients first contact their physiotherapy department online or via telephone and are triaged by a certified physiotherapist and are booked for an initial physiotherapy consultation. After triage, study information and the consent to participate, patients in the control group receive online data collection questionnaires identical to those of the intervention group at baseline and prior to the consultation, excluding the film and the questions linked to the film. The initial consultation will take place as usual according to the preferences of the physiotherapist. The physiotherapist will pose one question at start of the consultation to acknowledge the completion of control group questionnaires. Management subsequent to the initial consultation will follow usual management.

Locations

Country	Name	City	State
Sweden	Rehab Finspång, Primary Care Physiotherapy department	Finspång	Östergötland
Sweden	Linköping University	Linköping	Östergötland
Sweden	Rörelse och Hälsa, Primary Care Physiotherapy department	Linköping	Östergötland
Sweden	Rehab Väst, Primary Care Physiotherapy department	Motala	Östergötland
Sweden	Rehab Öst, Primary Care Physiotherapy department	Norrköping	Östergötland
Sweden	Bra Liv VC Tranås, Primary Care Physiotherapy department	Svärtinge	Jönköpings Län

Sponsors (2)

Lead Sponsor	Collaborator
Kajsa Johansson	The Research Council of South East Sweden (FORSS)

Country where clinical trial is conducted

Sweden, 

References & Publications (26)

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Linton SJ, Nicholas M, MacDonald S. Development of a short form of the Orebro Musculoskeletal Pain Screening Questionnaire. Spine (Phila Pa 1976). 2011 Oct 15;36(22):1891-5. doi: 10.1097/BRS.0b013e3181f8f775. — View Citation

Moseley, G. L., & Butler, D. S. (2017). Explain Pain Supercharged. NOI Group, Australia.

Nationella patientenkäten, Sverige Landsting och Regioner i Samverkan (2015). Rapport Analysuppdrag: Modellutveckling, utvärdering samt tidigare studier och enkäter. https://skr.se/download/18.40c889381840e60521aa1a14/1668006119029/Rapport%20Analysuppdrag_Modellutveckling,%20utv%C3%A4rdering%20samt%20tidigare%20studier%20och%20enk%C3%A4ter_2015.pdf

Nicholas MK, McGuire BE, Asghari A. A 2-item short form of the Pain Self-efficacy Questionnaire: development and psychometric evaluation of PSEQ-2. J Pain. 2015 Feb;16(2):153-63. doi: 10.1016/j.jpain.2014.11.002. Epub 2014 Nov 14. — View Citation

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Öhman, S. (2022). Design guidelines for a digital educational material for patients with benign acute and sub-acute musculoskeletal pain. [Bachelor of Science (BSc) thesis. Linköping University].

Olsen MF, Bjerre E, Hansen MD, Hilden J, Landler NE, Tendal B, Hrobjartsson A. Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. BMC Med. 2017 Feb 20;15(1):35. doi: 10.1186/s12916-016-0775-3. — View Citation

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Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10. — View Citation

Setchell J, Costa N, Ferreira M, Makovey J, Nielsen M, Hodges PW. Individuals' explanations for their persistent or recurrent low back pain: a cross-sectional survey. BMC Musculoskelet Disord. 2017 Nov 17;18(1):466. doi: 10.1186/s12891-017-1831-7. — View Citation

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Vowles KE, McCracken LM, Sowden G, Ashworth J. Psychological flexibility in coping with chronic pain: further examination of the brief pain coping inventory-2. Clin J Pain. 2014 Apr;30(4):324-30. doi: 10.1097/AJP.0b013e31829ea187. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	One-off Patient reported evaluation of the initial physiotherapy consultation	The patients (intervention and control groups) will evaluate the initial consultation via seven questions adapted and modified from the National Patient Survey, Sweden. 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 and concerns they had regarding their MSKP and to what extent they discussed what they themselves could do to improve their MSKP and health. The participants will also be asked if they felt they could reach a consensus in understanding with the physiotherapist regarding their MSKP, whether the physiotherapist considered their personal MSKP experiences and explained MSKP in a way that they could understand. The questions are answered on a scale of 0-10 with zero representing less positive evaluation and ten a fully positive evaluation in relation to each question.	24 hours post-initial physiotherapy consultation
Other	One-off Physiotherapist reported evaluation of the initial physiotherapy consultation	The physiotherapist participants will evaluate the initial physiotherapy consultation via three questions adapted and modified from the National Patient Survey, Sweden.; The physiotherapists 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 in understanding regarding the patients MSKP and whether they felt the patient actively took part in decision making regarding their care.; The questions are answered on a scale of 0-10 with zero representing less positive evaluation and ten a fully positive evaluation in relation to each question.	24 hours post-initial physiotherapy consultation
Other	Intervention's groups rating of the clarity of the film's key-messages	The intervention group will answer eight questions where they rate the clarity of the film's key messages. The film's key-messages reflect the following domains from the common-sense model of self-regulation; MSKP Identity, Timeline, Consequences, Causes, Control and Emotional representations.	After the first exposure to the film at baseline for patient participants in the intervention group only
Primary	Mean change from baseline and proportion of responders in self-reported Pain Self-efficacy measured using the Pain Self-efficacy questionnaire 10 (PSEQ-10) (within- and between group changes)	Pain self-efficacy will be measured using the PSEQ-10 (Nicholas, 2007). The PSEQ-10 is a self-reported ten item scale scored as a total (0-60) with a higher score indicating greater pain self-efficacy (higher score on PSEQ-10 = better outcome). The PSEQ-10 includes ten statements where patients are asked to rate, from zero to six, how confident they are that they can do certain things despite their pain (Nicholas, 2007).; Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.; Additional analysis will be conducted on proportion of responders in the intervention and control groups, with a responder defined as an individual with an 11.52 point improvement from baseline to 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.	The PSEQ-10 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline
Primary	Mean change from baseline and proportion of responders in self-reported Pain Intensity measured using numerical rating scale (NRS) (within- and between group changes)	Self-reported average pain intensity, worst pain intensity and best pain intensity in the previous 24 hours will be measured using three separate Numerical Rating Scales (NRS) (0-10; 0 = no pain to 10 = worst imaginable pain). NRS rating related to the past 24 hours has been chosen to avoid overlap of the ratings at the separate data collection time points.; Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.; Additional analysis will be conducted on proportion of responders in the intervention and control groups, with a responder defined as an individual with a two-point reduction on NRS from baseline to 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline	NRS will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline
Secondary	Mean change from baseline in self-reported Musculoskeletal pain illness perceptions measured using the Brief Illness Perception Questionnaire (BIPQ) (within- and between group changes)	The BIPQ has nine questions, eight use an 11-point NRS with anchor statements. Question 9 is a free text question where participants list the three most important factors they believed cause their MSKP (Broadbent et al., 2006).; Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial consultation and again at three months post-baseline.; BIPQ will be analysed as recommended by Broadbent et al (2015): As individual items and as total score (max 80). The total score gives an impression of the patient's perception of the threat level of their MSKP, with a higher score reflecting a higher threat (lower item or total score=better outcome). The causal item question will be collected at baseline, immediately following the baseline exposure to the film and again at 24 hours post-initial consultation. The causal item question will be analysed by grouping of answers into categories.	BIPQ will be collected at baseline, repeated directly after first exposure to the film, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline
Secondary	Mean change from baseline in self-reported level of reassurance as to the benign nature of MSKP will be measured using a single numerical rating scale (Reassurance NRS) (within- and between group changes)	Self-reported level of reassurance about the seriousness of MSKP will be measured using a reassurance NRS with an eleven-point scale (0-10). The reassurance NRS asks the participant how certain they are that there is not a serious condition causing their MSKP. A higher score indicates greater assurance. 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).; Change =Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.	Reassurance NRS will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.
Secondary	Mean change from baseline in self-reported traditional musculoskeletal pain coping strategies and psychological flexibility measured using the Brief Pain Coping Inventory 2 (BPCI-2) (within- and between group changes)	The BPCI-2 is a 19-item questionnaire, where participants are asked to report on how many days in the last week they adopted certain pain management strategies (0-7 days; Vowles et al., 2014). The BPCI-2 is scored as a total score (0-133) and also contains two sub-scales which measure traditional pain coping strategies (max 56) and psychological flexibility (max 77). Higher total or sub-scale scores indicate more adaptive coping (Vowles et al., 2014).; Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.	BPCI-2 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.
Secondary	Mean change in self-reported levels of physical activity measured using three screening questions developed for the Swedish national board of health and welfare (within- and between group changes)	The three questions ask the participants how many minutes in the last week they have performed activity that makes the breathless, how many minutes they have been otherwise physically active, for example house work or gardening, and how many hours they usually sit during a day (not including sleeping) (Kallings, 2014).; Change = Baseline score (mean minutes) compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.	Physical activity will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.
Secondary	Mean self-reported global rating of change measured using a global rating of change scale (GRoCs) measured at three time points (analysed for both within- and between group changes)	Global Rating of Change will be measured using a single item GRoCs scored on an 11-point scale. The 11-point scale is scored from minus five to plus five, anchored by the terms very much worse (minus five), unchanged (zero) and completely recovered (plus five) in accordance with the recommendation made by Kamper et al. (2009). The score is based on the time period from when the participant first contacted their physiotherapy department and were triaged to 24-48 hours prior to the initial physiotherapy consultation and again at three months post-baseline.	GRoCs will be collected at three time points; first 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline
Secondary	Total days of Sickness absence for each group (intervention and control) from baseline to three months post-baseline (between group difference)	Data on sickness certification will be collected for each participating patient via the Swedish social security database (Försäkringskassan) following completion of patient and physiotherapist outcome measure data collection. In addition the participants will self-rapport if they are currently on sick leave for their presenting MSKP complaint at the time of baseline data collection, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at the three month post-baseline data collection.	Total aggregated days (for all participants in each group) from baseline to three months post-baseline
Secondary	Total number of referrals for diagnostic imaging for each group (intervention and control) from baseline to three months post-baseline (between group differences)	Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland & Region Jönköpings län) following completion of patient and physiotherapist outcome measure data collection. The number of referrals made for diagnostic imaging for musculoskeletal diagnoses for each participant made during the time that elapses between baseline and three months post-baseline will be collected.	Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline
Secondary	Total number of referrals to tertiary/specialist care for musculoskeletal pain for each group (intervention and control) from baseline to three months post-baseline (between group differences)	Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland & Region Jönköpings län) following completion of patient and physiotherapist outcome measure data collection. The number of referrals made to tertiary/specialist care for musculoskeletal diagnoses for each participant made during the time that elapses between baseline and three months post-baseline will be collected.	Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline
Secondary	Total number of healthcare consultations attended for musculoskeletal pain for each group (intervention and control) from baseline to three months post-baseline (between group differences)	Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland & Region Jönköpings län) following completion of patient and physiotherapy outcome measure data collection. The number of healthcare appointments attended for musculoskeletal diagnoses for each participant during the time that elapses between baseline and three months post-baseline will be collected.	Total aggregated healthcare consultations attended (for all participants in each group) between baseline and three months post-baseline
Secondary	One-off screening at baseline with the Örebro Musculoskeletal pain screening questionnaire	The Örebro Musculoskeletal pain screening questionnaire (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).	Baseline only