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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Kajsa Johansson
- Enrollment
- 494
- Locations
- 6
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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:
- 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?
- 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 will be collected during 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 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.
Detailed Description
For more detailed information about the study see the attached study protocol
Investigators
Kajsa Johansson
Senior associate Professor
Linkoeping University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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)
Time Frame: 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
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.
Mean change from baseline and proportion of responders in self-reported Pain Intensity measured using numerical rating scale (NRS) (within- and between group changes)
Time Frame: 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
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.
Secondary Outcomes
- 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)
- Change in type and frequency of self-reported analgesic medication use (within and between group changes)(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.)
- Total days of Sickness absence for each group (intervention and control) from baseline to three months post-baseline (between group difference)(Total aggregated days (for all participants in each group) from baseline to three months post-baseline)
- Total number of referrals for diagnostic imaging for each group (intervention and control) from baseline to three months post-baseline (between group differences)(Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline)
- Total number of referrals to tertiary/specialist care for musculoskeletal pain for each group (intervention and control) from baseline to three months post-baseline (between group differences)(Total aggregated referrals (for all participants in each group) made between baseline and three months post-baseline)
- Total number of healthcare consultations attended for musculoskeletal pain for each group (intervention and control) from baseline to three months post-baseline (between group differences)(Total aggregated healthcare consultations attended (for all participants in each group) between baseline and three months post-baseline)
- Direct healthcare costs per patient(Total aggregated direct healthcare costs (for all participants in each group) between baseline and three months post-baseline)
- One-off screening at baseline with the Örebro Musculoskeletal pain screening questionnaire(Baseline only)