Clinical trial NCT06187428: The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
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
Keywords: pain
education
pain self efficacy
digitalisation
primary care
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: The Research Council of South East Sweden (FORSS)
First posted: 2024-01-02
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel randomised assignment to intervention (PainSMART) group or control (usual management) group
Primary purpose: TREATMENT

Brief 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 and data from central healthcare registers will be collected during and after 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 and direct costs incurred 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.

The final 30 to 40 participating patients in the study will also have their initial consultation with the physiotherapist audio recorded in order to enable analysis of any potential influence of the PainSMART-strategy on communication around pain during the consultation.

Detailed description: For more detailed information about the study see the attached study protocol and the attached statistical analysis plan.

Eligibility 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 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

Primary outcomes:
measure: 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)
timeFrame: 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
measure: Mean change from baseline and proportion of responders in self-reported Pain Intensity measured using numerical rating scale (NRS) (within- and between group changes)
timeFrame: 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 outcomes:
measure: Mean change from baseline in self-reported Musculoskeletal pain illness perceptions measured using the Brief Illness Perception Questionnaire (BIPQ) (within- and between group changes)
timeFrame: 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
measure: 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)
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: 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)
timeFrame: 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.
measure: 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)
timeFrame: 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
measure: Change in type and frequency of self-reported analgesic medication use (within and between group changes)
timeFrame: 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.
measure: Total days of Sickness absence for each group (intervention and control) from baseline to three months post-baseline (between group difference)
timeFrame: Total aggregated days (for all participants in each group) from baseline to three months post-baseline
measure: Total number of referrals for diagnostic imaging for each group (intervention and control) from baseline to three months post-baseline (between group differences)
timeFrame: Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline
measure: 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)
timeFrame: Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline
measure: 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)
timeFrame: Total aggregated healthcare consultations attended (for all participants in each group) between baseline and three months post-baseline
measure: Direct healthcare costs per patient
timeFrame: Total aggregated direct healthcare costs (for all participants in each group) between baseline and three months post-baseline
measure: One-off screening at baseline with the Örebro Musculoskeletal pain screening questionnaire
timeFrame: Baseline only
Other outcomes:
measure: One-off Patient reported evaluation of the initial physiotherapy consultation
timeFrame: 24 hours post-initial physiotherapy consultation
measure: One-off Physiotherapist reported evaluation of the initial physiotherapy consultation
timeFrame: 24 hours post-initial physiotherapy consultation
measure: Intervention's groups rating of the clarity of the film's key-messages
timeFrame: After the first exposure to the film at baseline for patient participants in the intervention group only
measure: Qualitative exploration of the influence of the PainSMART-strategy on the initial physiotherapy consultation (final 30 to 40 patient participants only)
timeFrame: Audio recording during the initial physioterapy consultation for the final 30 to 40 patient participants in the RCT
measure: One-off Physiotherapist reported evaluation of patients preparedness for the initial physiotherapy consultation
timeFrame: Collected after each physiotherapist has conducted their final PainSMART study consultation
Locations:
city: Svärtinge
country: Sweden
facility: Bra Liv VC Tranås, Primary Care Physiotherapy department
state: Jönköpings Län
city: Finspång
country: Sweden
facility: Rehab Finspång, Primary Care Physiotherapy department
state: Östergötland
city: Linköping
country: Sweden
facility: Rörelse och Hälsa, Primary Care Physiotherapy department
state: Östergötland
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
city: Motala
country: Sweden
facility: Rehab Väst, Primary Care Physiotherapy department
state: Östergötland
city: Norrköping
country: Sweden
facility: Rehab Öst, Primary Care Physiotherapy department
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Kajsa Johansson, PhD
role: STUDY_CHAIR
affiliation: Linkoeping University
name: Richard M Thompson, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Maria Fors, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Allan Abbott, PhD
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Ann-Sofi Kammerlind, PhD
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Pia Tingström, PhD
role: STUDY_DIRECTOR
References:
citation: Försäkringskassan (2023, June 20) Statistical database. Statistics related to illness. https://www.forsakringskassan.se/statistik-och-analys/statistikdatabas#!/sjuk/sjp-antal-mottagare-nettodagar-belopp
citation: Kallings, L. (2014). Validering av Socialstyrelsens screeningfrågor om fysisk aktivitet. The Swedish National Board of Health and Welfare. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/dokument-webb/nationella-riktlinjer/levnadsvanor-validering-av-indikatorfragor-till-patienter-om-fysisk-aktivitet.pdf
citation: Moseley, G. L., & Butler, D. S. (2017). Explain Pain Supercharged. NOI Group, Australia.
citation: Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the Brief Illness Perception Questionnaire. Psychol Health. 2015;30(11):1361-85. doi: 10.1080/08870446.2015.1070851. Epub 2015 Aug 26.
citation: Caneiro JP, Bunzli S, O'Sullivan P. Beliefs about the body and pain: the critical role in musculoskeletal pain management. Braz J Phys Ther. 2021 Jan-Feb;25(1):17-29. doi: 10.1016/j.bjpt.2020.06.003. Epub 2020 Jun 20.
citation: Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima E Sa Resende F, Ostelo RW, Pillastrini P. Responsiveness and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. 2016 Jun;17(6):707-18. doi: 10.1016/j.jpain.2016.02.012. Epub 2016 Mar 11.
citation: Deyo RA, Diehl AK, Rosenthal M. Reducing roentgenography use. Can patient expectations be altered? Arch Intern Med. 1987 Jan;147(1):141-5. doi: 10.1001/archinte.147.1.141.
citation: Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.
citation: Emilsson M, Berndtsson I, Gustafsson PA, Horne R, Marteinsdottir I. Reliability and validation of Swedish translation of Beliefs about Medication Specific (BMQ-Specific) and Brief Illness Perception Questionnaire (B-IPQ) for use in adolescents with attention-deficit hyperactivity disorder. Nord J Psychiatry. 2020 Feb;74(2):89-95. doi: 10.1080/08039488.2019.1674376. Epub 2019 Oct 9.
citation: Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International Framework for Red Flags for Potential Serious Spinal Pathologies. J Orthop Sports Phys Ther. 2020 Jul;50(7):350-372. doi: 10.2519/jospt.2020.9971. Epub 2020 May 21.
citation: Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.
citation: Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
citation: Leventhal H, Phillips LA, Burns E. The Common-Sense Model of Self-Regulation (CSM): a dynamic framework for understanding illness self-management. J Behav Med. 2016 Dec;39(6):935-946. doi: 10.1007/s10865-016-9782-2. Epub 2016 Aug 11.
citation: 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.
citation: Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
citation: 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.
citation: 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.
citation: Olsen MF, Bjerre E, Hansen MD, Tendal B, Hilden J, Hrobjartsson A. Minimum clinically important differences in chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies. J Clin Epidemiol. 2018 Sep;101:87-106.e2. doi: 10.1016/j.jclinepi.2018.05.007. Epub 2018 May 21.
citation: 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.
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.
citation: Sox HC Jr, Margulies I, Sox CH. Psychologically mediated effects of diagnostic tests. Ann Intern Med. 1981 Dec;95(6):680-5. doi: 10.7326/0003-4819-95-6-680.
citation: 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.
citation: 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
citation: Barkman, S. (2022). What do primary care professionals who meet patients with musculoskeletal pain need to facilitate the healthcare encounter? A qualitative interview study that explores the needs of professionals in primary care for knowledge and communication about pain. [Bachelor of Science (BSc) thesis. Linköping University].
citation: Stjärnskog, A. (2022). My pain, my needs. A qualitative interview study to investigate how primary care patients with acute and subacute musculoskeletal pain reason about their pain and what further knowledge they require. [Bachelor of Science (BSc) thesis. Linköping University].
citation: 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].