The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care Physiotherapy
- Conditions
- Physical Activity LevelAnxietyPainPain, ChronicSelf EfficacyReferral and ConsultationCommunicationPain AcuteIllness PerceptionsSickness Absence
- Interventions
- Other: PainSMART-strategyOther: Usual physiotherapy management
- Registration Number
- NCT06187428
- Lead Sponsor
- Kajsa Johansson
- 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:
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 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 494
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PainSMART-strategy (intervention) group PainSMART-strategy 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. Usual physiotherapy management (control) group Usual physiotherapy management Patient participants randomised to the control group will follow the usual physiotherapy management pathway at the physiotherapy departments participating in the study.
- Primary Outcome Measures
Name Time Method 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) 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) 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 Outcome Measures
Name Time Method 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 The BIPQ has nine questions, eight use an 11-point NRS with anchor statements. Question 9 is a free text question where participants list the three most important factors they believed cause their MSKP (Broadbent et al., 2006).
Change = Baseline score compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial consultation and again at three months post-baseline.
BIPQ will be analysed as recommended by Broadbent et al (2015): As individual items and as total score (max 80). The total score gives an impression of the patient's perception of the threat level of their MSKP, with a higher score reflecting a higher threat (lower item or total score=better outcome). The causal item question will be collected at baseline, immediately following the baseline exposure to the film and again at 24 hours post-initial consultation. The causal item question will be analysed by grouping of answers into categories.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 Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland \& Region Jönköpings län) following completion of patient and physiotherapist outcome measure data collection. The number of referrals made to tertiary/specialist care for musculoskeletal diagnoses for each participant made during the time that elapses between baseline and three months post-baseline will be collected.
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. Self-reported level of reassurance about the seriousness of MSKP will be measured using a reassurance NRS with an eleven-point scale (0-10). The reassurance NRS asks the participant how certain they are that there is not a serious condition causing their MSKP. A higher score indicates greater assurance. This question has been adapted from the original research by Sox et al. (1981) and has been previously used in research on acute LBP (Deyo et al., 1987).
Change =Baseline score compared to score 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. The BPCI-2 is a 19-item questionnaire, where participants are asked to report on how many days in the last week they adopted certain pain management strategies (0-7 days; Vowles et al., 2014). The BPCI-2 is scored as a total score (0-133) and also contains two sub-scales which measure traditional pain coping strategies (max 56) and psychological flexibility (max 77; with 4 reverse scored items). Higher total or sub-scale scores indicate more adaptive coping (Vowles et al., 2014).
Change = Baseline score compared to score 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. The three questions ask the participants how many minutes in the last week they have performed activity that makes the breathless, how many minutes they have been otherwise physically active, for example house work or gardening, and how many hours they usually sit during a day (not including sleeping) (Kallings, 2014).
Change = Within and between group mean change in the scores over time from baseline to follow-up three months post-baseline (all time points). Scores on question regarding "Moderate to intensive exercise" and "Other physical activity beside exercise" will also be converted to activity minutes per week \< 150min/w or ≥ 150min/w.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 Global Rating of Change will be measured using a single item GRoCs scored on an 11-point scale. The 11-point scale is scored from minus five to plus five, anchored by the terms very much worse (minus five), unchanged (zero) and completely recovered (plus five) in accordance with the recommendation made by Kamper et al. (2009). The score is based on the time period from when the participant first contacted their physiotherapy department and were triaged to 24-48 hours prior to the initial physiotherapy consultation and again at three months post-baseline.
The score will be dichotomized into improved (1-5) and unchanged/worse (-5-0).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. Self-reported analgesic medication use (type and consumption) for the presenting MSKP complaint will be collected via two questions. The first question establishes analgesic consumption and consumption frequency quantified via one question with response options: Yes, on a regular basis; Yes, sometimes; or No. The type of analgesics taken for MSKP is established via one question with six response options: 1. Paracetamol, 2. NSAID, 3. Opioids, 4. Gabapentinoids/Tricyclic antidepressants/Serotonin-norepinephrine reuptake inhibitors 5. Don't know 6. Other.
Change = Baseline consumption (type \& regularity) compared to score 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at three months post-baseline. Analgesic type will be grouped into 3 groups for analysis:
1. Paracetamol, 2. NSAID, 3. Opioids/gabapentinoids/Tricyclic antidepressants/Serotonin-norepinephrine reuptake inhibitors.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 Data on sickness certification will be collected for each participating patient via the Swedish social security database (Försäkringskassan) following completion of patient and physiotherapist outcome measure data collection. In addition the participants will self-rapport if they are currently on sick leave for their presenting MSKP complaint at the time of baseline data collection, 24-72 hours prior to the initial physiotherapy consultation, 24 hours post-initial physiotherapy consultation and again at the three month post-baseline data collection.
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 Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland \& Region Jönköpings län) following completion of patient and physiotherapist outcome measure data collection. The number of referrals made for diagnostic imaging for musculoskeletal diagnoses for each participant made during the time that elapses between baseline and three months post-baseline will be collected.
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 Data will be collected for each participating patient via regional healthcare databases (Rebus Vård, Region Östergötland \& Region Jönköpings län) following completion of patient and physiotherapy outcome measure data collection. The number of healthcare appointments attended for musculoskeletal diagnoses for each participant during the time that elapses between baseline and three months post-baseline will be collected. Patients will also self-report if they have attended healthcare consultations for their MSKP presenting complaint with healthcare practitioners who are not the physiotherapist involved in the trial.
Direct healthcare costs per patient Total aggregated direct healthcare costs (for all participants in each group) between baseline and three months post-baseline Direct costs per patient for healthcare during the MSKP study period will be collected from the central healthcare database. A comparison will be made between the intervention and control groups to establish if the PainSMART-strategy can improve health outcomes and the effectiveness of the physiotherapy management pathway.
One-off screening at baseline with the Örebro Musculoskeletal pain screening questionnaire Baseline only The Örebro Musculoskeletal pain screening questionnaire (ÖMPSQ) is a ten item questionnaire which assesses five constructs; self-perceived function, pain experience, distress, fear-avoidance beliefs and return to work expectancy (Linton et al., 2011). The ÖMPSQ was developed in a primary care setting and the questionnaire is scored from 0-100 where a higher score indicates higher risk for future work related disability (Linton et al., 2011).
Trial Locations
- Locations (6)
Bra Liv VC Tranås, Primary Care Physiotherapy department
🇸🇪Svärtinge, Jönköpings Län, Sweden
Rehab Finspång, Primary Care Physiotherapy department
🇸🇪Finspång, Östergötland, Sweden
Rörelse och Hälsa, Primary Care Physiotherapy department
🇸🇪Linköping, Östergötland, Sweden
Linköping University
🇸🇪Linköping, Östergötland, Sweden
Rehab Väst, Primary Care Physiotherapy department
🇸🇪Motala, Östergötland, Sweden
Rehab Öst, Primary Care Physiotherapy department
🇸🇪Norrköping, Östergötland, Sweden