Trials / Completed

CompletedNCT06187428

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

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 494 (actual)

Sponsor: Kajsa Johansson · Other Government
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2024-01-22
Primary completion: 2025-03-10
Completion: 2025-03-10
First posted: 2024-01-02
Last updated: 2025-06-12

Locations

6 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT06187428. Inclusion in this directory is not an endorsement.