NCT06187428: PainSMART

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

Completed NA Last updated 12 June 2025

What this trial tests

NA trial testing PainSMART-strategy in Pain in 494 participants. Completed in 10 March 2025.

Timeline

22 January 2024

Primary endpoint
10 March 2025

10 March 2025

Quick facts

Lead sponsor	Kajsa Johansson
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	494
Start date	22 January 2024
Primary completion	10 March 2025
Estimated completion	10 March 2025
Sites	6 locations across Sweden

Drugs / interventions tested

• PainSMART-strategy
• Usual physiotherapy management

Conditions studied

• Pain — all drugs for Pain →
• Pain Acute — all drugs for Pain Acute →
• Pain, Chronic — all drugs for Pain, Chronic →
• Self Efficacy — all drugs for Self Efficacy →

Sponsor

Kajsa Johansson

Who can join

18 and older, any sex, with Pain or Pain Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The PainSMART project: Protocol for 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.
   Thompson R, Fors M, Kammerlind AS, Tingström P, et al · · 2025 · PMID 39883724 · DOI 10.1371/journal.pone.0316806