The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy
NCT ID: NCT06187428
Last Updated: 2025-06-12
Study Results
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Basic Information
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COMPLETED
NA
494 participants
INTERVENTIONAL
2024-01-22
2025-03-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PainSMART-strategy (intervention) group
Patients eligible for inclusion first contact the physiotherapy department and are triaged by a physiotherapist and booked for an initial physiotherapy consultation. After triage, study information and the consent to participate, patients randomised to the intervention group receive the PainSMART-strategy as an adjunct to usual MSKP physiotherapy management.
The strategy includes; exposure to the film 'Be PainSMART:er' at baseline, together with ratings of the clarity of the film's key-messages, a second film exposure prior to the initial consultation and three questions related to the film at the initial consultation.
Baseline data collection will occur prior to first exposure to the film. The film is available exclusively via the questionnaires via Region Östergötland's Quick channel. Therefore it is not shareable or available via online searching.
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 (control) group
Patient participants randomised to the control group will follow the usual physiotherapy management pathway at the physiotherapy departments participating in the study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Adult patients (18 years or older)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The Research Council of South East Sweden (FORSS)
UNKNOWN
Kajsa Johansson
OTHER_GOV
Responsible Party
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Kajsa Johansson
Senior associate Professor
Principal Investigators
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Kajsa Johansson, PhD
Role: STUDY_CHAIR
Linkoeping University
Richard M Thompson, MSc
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Maria Fors, PhD
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Allan Abbott, PhD
Role: STUDY_DIRECTOR
Linkoeping University
Ann-Sofi Kammerlind, PhD
Role: STUDY_DIRECTOR
Linkoeping University
Pia Tingström, PhD
Role: STUDY_DIRECTOR
Linkoeping University
Locations
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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
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Primary care rehabilitation
Identifier Type: OTHER
Identifier Source: secondary_id
Primary care rehabilitation
Identifier Type: OTHER
Identifier Source: secondary_id
Dnr 2023-05968-01
Identifier Type: -
Identifier Source: org_study_id
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