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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
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.
For more detailed information about the study see the attached study protocol and the attached statistical analysis plan.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Bra Liv VC Tranås, Primary Care Physiotherapy department
Svärtinge, Jönköping County, Sweden
Rehab Finspång, Primary Care Physiotherapy department
Finspång, Östergötland County, Sweden
Rörelse och Hälsa, Primary Care Physiotherapy department
Linköping, Östergötland County, Sweden
Linköping University
Linköping, Östergötland County, Sweden
Rehab Väst, Primary Care Physiotherapy department
Motala, Östergötland County, Sweden
Rehab Öst, Primary Care Physiotherapy department
Norrköping, Östergötland County, Sweden
Start Date
January 22, 2024
Primary Completion Date
March 10, 2025
Completion Date
March 10, 2025
Last Updated
June 12, 2025
494
ACTUAL participants
PainSMART-strategy
OTHER
Usual physiotherapy management
OTHER
Lead Sponsor
Kajsa Johansson
Collaborators
NCT06346132
NCT07482709
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07351968