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

NCT06187428 | Completed

• 2 other identifiers: Dnr 2023-05968-01Primary care rehabilitation
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 6

Brief 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:

• 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

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

Keywords

pain; education; pain self efficacy; digitalisation; primary care

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline and proportion of responders in self-reported Pain Self-efficacy measured using the Pain Self-efficacy questionnaire 10 (PSEQ-10) (within- and between group changes)

  Pain self-efficacy will be measured using the PSEQ-10 (Nicholas, 2007). The PSEQ-10 is a self-reported ten item scale scored as a total (0-60) with a higher score indicating greater pain self-efficacy (higher score = better outcome). The PSEQ-10 includes ten statements where patients are asked to rate, from zero to six, how confident they are that they can do certain things despite their pain. Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation (primary outcome point 1) and again at three months post-baseline (primary outcome point 2). Secondary analyses of within and between-group differences in proportion of responders will be conducted based on the study specific minimal clinical important difference (MCID) for primary outcomes at primary outcome time points. The MCID will be calculated for the whole cohort using an anchor method based on Global rating of change scores.

  The PSEQ-10 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

• Mean change from baseline and proportion of responders in self-reported Pain Intensity measured using numerical rating scale (NRS) (within- and between group changes)

  Self-reported average pain intensity (primary outcome), worst pain intensity and best pain intensity in the previous 24 hours will be measured using three separate Numerical Rating Scales (NRS) (0-10; 0 = no pain to 10 = worst imaginable pain). NRS rating related to the past 24 hours has been chosen to avoid overlap of the ratings at the separate data collection time points. Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation (primary outcome point 1) and again at three months post-baseline (primary outcome point 2). Secondary analyses of within and between-group differences in proportion of responders will be conducted based on the study specific minimal clinical important difference (MCID) for primary outcomes at primary outcome time points. The MCID will be calculated for the whole cohort using an anchor method based on Global rating of change scores.

  NRS will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

Secondary Outcomes (12)

• Mean change from baseline in self-reported Musculoskeletal pain illness perceptions measured using the Brief Illness Perception Questionnaire (BIPQ) (within- and between group changes)

  BIPQ will be collected at baseline, repeated directly after first exposure to the film, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

• Mean change from baseline in self-reported level of reassurance as to the benign nature of MSKP will be measured using a single numerical rating scale (Reassurance NRS) (within- and between group changes)

  Reassurance NRS will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

• Mean change from baseline in self-reported traditional musculoskeletal pain coping strategies and psychological flexibility measured using the Brief Pain Coping Inventory 2 (BPCI-2) (within- and between group changes)

  BPCI-2 will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

• Mean change in self-reported levels of physical activity measured using three screening questions developed for the Swedish national board of health and welfare (within- and between group changes)

  Physical activity will be collected at baseline, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline.

• Mean self-reported global rating of change measured using a global rating of change scale (GRoCs) measured at three time points (analysed for both within- and between group changes)

  GRoCs will be collected at three time points; first 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline

Other Outcomes (5)

• One-off Patient reported evaluation of the initial physiotherapy consultation

  24 hours post-initial physiotherapy consultation

• One-off Physiotherapist reported evaluation of the initial physiotherapy consultation

  24 hours post-initial physiotherapy consultation

• Intervention's groups rating of the clarity of the film's key-messages

  After the first exposure to the film at baseline for patient participants in the intervention group only

Study Arms (2)

PainSMART-strategy (intervention) group

EXPERIMENTAL

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.

Other: PainSMART-strategy

Usual physiotherapy management (control) group

ACTIVE COMPARATOR

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

Other: Usual physiotherapy management

Interventions

PainSMART-strategy OTHER

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.

PainSMART-strategy (intervention) group

Usual physiotherapy management OTHER

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.

Usual physiotherapy management (control) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kajsa Johansson: lead
• The Research Council of South East Sweden (FORSS): collaborator

Study Sites (6)

Bra Liv VC Tranås, Primary Care Physiotherapy department

Svärtinge, Jönköping County, 60580, Sweden

Location

Rehab Finspång, Primary Care Physiotherapy department

Finspång, Östergötland County, 612 25, Sweden

Location

Rörelse och Hälsa, Primary Care Physiotherapy department

Linköping, Östergötland County, 581 85, Sweden

Location

Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Rehab Väst, Primary Care Physiotherapy department

Motala, Östergötland County, 581 85, Sweden

Location

Rehab Öst, Primary Care Physiotherapy department

Norrköping, Östergötland County, 612 25, Sweden

Location

Related Publications (27)

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MeSH Terms

Conditions

Pain; Acute Pain; Chronic Pain; Anxiety Disorders; Communication

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Kajsa Johansson, PhD

  Linkoeping University

  STUDY CHAIR

• Richard M Thompson, MSc

  Linkoeping University

  PRINCIPAL INVESTIGATOR

• Maria Fors, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

• Allan Abbott, PhD

  Linkoeping University

  STUDY DIRECTOR

• Ann-Sofi Kammerlind, PhD

  Linkoeping University

  STUDY DIRECTOR

• Pia Tingström, PhD

  Linkoeping University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes are collected digitally and pseudonymised and the statistical analyses will be blinded to group allocation since the randomisation is concealed during this process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior associate Professor

Model Details: Two-arm parallel randomised assignment to intervention (PainSMART) group or control (usual management) group

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: January 22, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol has been uploaded in conjunction with submission of this registration and prior to the start of patient recruitment to the first phase on the RCT (January 19, 2024). An update to the study protocol has been uploaded prior to the start of patient recruitment to the qualitative phase of the RCT (September 25, 2024) A statistical analysis plan has been uploaded to Clinicaltrials.gov in conjunction with an update to the protocol (September 25, 2024). English translated copies of the informed consent forms for both patient and physiotherapist participants are available from the corresponding author on request. Individual patient data (IPD) will be first made available after conclusion of data collection and publication of the study results- expected conclusion end of 2027
• Access Criteria: Upon reasonable request from a credible institution or research group. Individual patient data will be shared pseudonymised upon reasonable request. This will include background data, patient reported outcome measure data and patient and physiotherapist experience measure data.

Locations

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