The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy
NCT06187428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 494
Last updated 2025-06-12
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.
Conditions
Interventions
- 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.
- OTHER
-
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.
Sponsors & Collaborators
-
The Research Council of South East Sweden (FORSS)
collaborator UNKNOWN -
Kajsa Johansson
lead OTHER_GOV
Principal Investigators
-
Kajsa Johansson, PhD · Linkoeping University
-
Richard M Thompson, MSc · Linkoeping University
-
Maria Fors, PhD · Linkoeping University
-
Allan Abbott, PhD · Linkoeping University
-
Ann-Sofi Kammerlind, PhD · Linkoeping University
-
Pia Tingström, PhD · Linkoeping University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-22
- Primary Completion
- 2025-03-10
- Completion
- 2025-03-10
Countries
- Sweden
Study Locations
More Related Trials
-
Subacute Low Back Pain in Active Duty
NCT03502187 ·Status: COMPLETED ·Phase: NA
-
Implementation of a Best Practice Primary Health Care Model for Low Back Pain
NCT03147300 ·Status: COMPLETED ·Phase: NA
-
Trial on Subacute Low Back Pain
NCT00923429 ·Status: COMPLETED ·Phase: NA
-
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
NCT04283370 ·Status: COMPLETED ·Phase: NA
-
Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
NCT03581123 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Different Exercise Programs Plus Photobiomodulation on Non-specific Low-back Pain.
NCT04887987 ·Status: COMPLETED ·Phase: NA
-
Markers of Outcome - a Cohort Study of LBP in Primary Health Care
NCT03108339 ·Status: COMPLETED
-
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
NCT03921840 ·Status: COMPLETED ·Phase: NA
-
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
NCT05022121 ·Status: COMPLETED ·Phase: NA
-
A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain
NCT03758807 ·Status: COMPLETED ·Phase: NA
-
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
NCT03270631 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
A Digital Support to Facilitate Sustainable Return to Work for Persons With Chronic Pain and Their Employers
NCT05058547 ·Status: UNKNOWN ·Phase: NA
-
Effects of Pain Neuroscience Education vs. Self-Management Education in Low Back Pain
NCT03714061 ·Status: COMPLETED ·Phase: NA
-
Digital Training Interventions for Low Back Pain
NCT05679167 ·Status: RECRUITING ·Phase: NA
-
Effectiveness of a Home Rehabilitation Program vs an e-Health Program in Patients With Chronic Low Back Pain
NCT03469024 ·Status: COMPLETED ·Phase: NA
-
MAT Pilates and MIHA Combined Exercise Programs in Patients With Nonspecific Back Pain
NCT07286760 ·Status: COMPLETED ·Phase: NA
-
Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain
NCT01719276 ·Status: UNKNOWN ·Phase: NA
-
Benefits of Adapted Physical Activity for Chronic Osteoarticular Pain in Patients With Multiple Myeloma
NCT05548686 ·Status: UNKNOWN ·Phase: NA
-
Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain
NCT06498271 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Comparison of Two Different Methods of Physical Therapy to Treat Acute and Subacute Low Back Pain
NCT02060617 ·Status: COMPLETED ·Phase: NA
-
SMART Stepped Care Management for Low Back Pain in the Military Health System
NCT04172038 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Postural Control and Trunk Neuromuscular Activation in Athletes With Chronic Low Back Pain
NCT02969785 ·Status: COMPLETED ·Phase: NA
-
The Effect of Workplace Interventions on the Treatment of Low-back Pain
NCT03481426 ·Status: COMPLETED ·Phase: NA
-
The Kaia Back Pain Intervention for Self-management of Low Back Pain
NCT04290078 ·Status: UNKNOWN ·Phase: NA
-
Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
NCT06156605 ·Status: COMPLETED ·Phase: NA