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

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.

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.

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.

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.

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.

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.

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).

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:

• Paracetamol, 2. NSAID, 3. Opioids/gabapentinoids/Tricyclic antidepressants/Serotonin-norepinephrine reuptake inhibitors.

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.

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.

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.

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 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.

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).

The patients (intervention and control groups) will evaluate the initial consultation via seven questions adapted and modified from the National Patient Survey, Sweden. The seven questions evaluate if the patients felt that they had the possibility to talk sufficiently about their MSKP, whether they felt included in decision making around their care, whether they had the opportunity to discuss any worries and concerns they had regarding their MSKP and to what extent they discussed what they themselves could do to improve their MSKP and health. The participants will also be asked if they felt they could reach a consensus in understanding with the physiotherapist regarding their MSKP, whether the physiotherapist considered their personal MSKP experiences and explained MSKP in a way that they could understand. The questions are answered on a scale of 0-10 with zero representing less positive evaluation and ten a fully positive evaluation in relation to each question.

The physiotherapist participants will evaluate the initial physiotherapy consultation via three questions adapted and modified from the National Patient Survey, Sweden.

The physiotherapists will answer three questions rating whether they felt they received sufficient information from the patient to adequately make clinical judgements regarding the patient's MSKP, whether they and the patient could reach a consensus in understanding regarding the patients MSKP and whether they felt the patient actively took part in decision making regarding their care.

The questions are answered on a scale of 0-10 with zero representing less positive evaluation and ten a fully positive evaluation in relation to each question.

The intervention group will answer eight questions where they rate the clarity of the film's key messages. The film's key-messages reflect the following domains from the common-sense model of self-regulation; MSKP Identity, Timeline, Consequences, Causes, Control and Emotional representations.

Naturally occurring audio recordings of the initial physiotherapy consultations will be collected using Dictaphones for the final 30 to 40 patient participants in the trial only. This data will be used to conduct qualitative exploration of if or how exposure to the PainSMART-strategy influences communication around pain at the initial physiotherapy consultation

Physiotherapists' experiences of their perception of the participating patients' preparedness for the initial consultation will be collected via one question for the intervention group and one question for the control group. The question will ask the physiotherapists to rate, on a scale from zero to ten, to what extent they felt that the patients in the film respective control groups were prepared for their initial physiotherapy consultation. Specifically the question askes to what extent the patient seemed to have reflected over biopsychosocial factors that may have influenced their pain experience and its impact on function and wellbeing prior to the initial consultation.