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

Kajsa Johansson

Status: Completed

Conditions: Illness Perceptions; Self Efficacy; Communication; Physical Activity Level; Anxiety; Sickness Absence; Pain Acute; Patient-Centered Care; Worry; Referral and Consultation; Pain, Chronic; Pain

Treatments: Other: PainSMART-strategy; Other: Usual physiotherapy management

Study type: Interventional

Funder types: Other

Identifiers

NCT06187428

Dnr 2023-05968-01

Primary care rehabilitation (Other Identifier)

Details and patient eligibility

About

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.

Full description

For more detailed information about the study see the attached study protocol and the attached statistical analysis plan.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who, via telephone or online text-based triage, are judged to have benign MSKP and are booked for an initial physiotherapy consultation at one of the five participating physiotherapy departments
• Adult patients (18 years or older)

Exclusion criteria

• Patients who are judged to require urgent medical examination due to suspected serious pathology (red flags)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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494 participants in 2 patient groups

PainSMART-strategy (intervention) group

Experimental group

Description:

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.

Treatment:

Other: PainSMART-strategy

Usual physiotherapy management (control) group

Active Comparator group

Description:

Patient participants randomised to the control group will follow the usual physiotherapy management pathway at the physiotherapy departments participating in the study.

Treatment:

Other: Usual physiotherapy management