Feasibility of assessing acceptability, cost-effectiveness and comparative clinical efficacy of the UPLIFT program vs. usual physiotherapy care for people with persistent low back pain: a pilot randomised non-inferiority design controlled trial

INTERVENTION: Participants allocated to the intervention group will participate in the UPLIFT program. UPLIFT is a 5‐week program consisting of weekly 90‐minute group sessions that combine education (60 Minutes) followed by exercise (30 Minutes). Sessions take place in the allied health outpatient clinic at thenGold Coast University Hospital, utilizing a meeting room for the education and an adjacent exercise gym room for the exercise. The education is delivered in a group setting. Group sizes are between 8 to 10 participants including 2 physiotherapists and an "expert" patient. Each education session targets a different theme: 1) pain neuroscience; 2) activity pacing; 3) flare‐up management; 4) acceptance; and 5) adopting healthy lifestyle behaviors (including sleep hygiene and movement). UPLIFT incorporates motivational interviewing techniques allowing participants to undertake appropriate cognitive and experiential processing of the program’s content. The 'expert" patient is a volunteer peer mentor who has successfully completed UPLIFT. They assist in facilitating the program by sharing their own experience with participants during the group sessions. The mentors are given three hours of face‐to‐face training by the program’s lead physiotherapists on the program’s content, communication skills (ie motivational interviewing techniques and coaching principles) and self‐care strategies. Lessons are open and conversational, rather than didactic. UPLIFT’s interactive delivery style aims to improve participants’ knowledge, which underpins behavior change. Patients in the UPLIFT program are considered active partners in their rehabilitation, aiming to reconceptualize their understanding of pain, develop active coping strategies to self‐manage LBP, and re‐engage in value‐based activi CONDITION: Anaesthesiology ‐ Pain management Musculoskeletal ‐ Other muscular and skeletal disorders persistent low back pain;pain management; ; persistent low back pain ; pain management SECONDARY OUTCOME: Secondary outcome 4: The effect of the UPLIFT program on patients’ fear avoidance (as compared to usual physiotherapy care) will be evaluated using the Fear avoidance beliefs questionnaire (FABQ) which measures patients’ fear of pain, and consequent physical activity avoidance due to this fear. The FABQ consists of 16 items; higher scores are indicative of greater fear and avoidance beliefs. The FABQ has high test‐retest reproducibility [At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a suite of questionnaires, which will take between 30 and 45 minutes. These will be administered via paper surveys, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5‐weeks following completion of baseline measures for the control group and again at 6‐month follow‐up, participants will complete the same suite of questionnaires, as well as the GROC scale. Assessment at baseline and 5‐week follow‐up will occur at Gold Coast University Hospital. At 6‐month follow‐up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher. ] Secondary outcome 1: The effect of the UPLIFT program on patients’ pain disability (as compared to usual physiotherapy care) will be evaluated using the ; Oswestry (LBP) Disability Index (ODI) which measures the level of function (degree of disability) in activities of daily living in a person with LBP. ; [ At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a suite of questionnaires, which will take between 30 and 45 minutes. These will be administered via paper surveys, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5‐weeks following completion of baseline measures for the control group and again at 6‐month follow‐up, participants will complete the same suite of questionnaires, as well as the GROC scale. Assessment at baseline and 5‐week follow‐up will occur at Gold Coast University Hospital. At 6‐month follow‐up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher. ] Secondary outcome 2: The effect of the UPLIFT program on patients’ catastrophic thinking (as compared to usual physiotherapy care) will be evaluated using the Pain Catastrophising Scale (PCS) which measures catastrophic thinking related to pain and is used extensively in clinical practice and in research. Pain catastrophising affects how individuals experience pain. The PCS consists of 13 items and has been shown to have high internal consistency [At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a suite of questionnaires, which will take between 30 and 45 minutes. These will be administered via paper surveys, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5‐weeks following completion of baseline measures for the control group and again at 6‐month follow‐up, participants will complete the same suite of questionnaires, as well as the GROC scale. Assessment at baseline and 5‐week follow‐up will occur at Gold Coast University Hospital. At 6‐month follow‐up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher. ] Secondary outcome 3: The effect of the UPLIFT program on patients’ pain self efficacy (as compared to usual physiotherapy care) will be evaluated using the Pain self‐efficacy questionnaire (PSEQ) which measures people’s (with persistent pain) confidence in performing activities while in pain. Low pain self‐efficacy is a predictor of people being at risk of long‐term disability and depression, while higher self‐efficacy appears to enhance and maintain the long‐term effects of rehabilitation. The PSEQ is a 10‐item questionnaire. Internal consistency is excellent and test‐retest reliability is high[At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a suite of questionnaires, which will take between 30 and 45 minutes. These will be administered via paper surveys, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5‐weeks following completion of baseline measures for the control group and again at 6‐month follow‐up, participants will complete the same suite of questionnaires, as well as the GROC scale. Assessment at baseline and 5‐week follow‐up will occur at Gold Coast University Hospital. At 6‐month follow‐up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher. ] Secondary outcome 5: The effect of the UPLIFT program on patients’ pain intensity and inteference (as compared to usual physiotherapy care) will be evaluated using the brief Pain inventory (BPI) which measures two different aspects of pain; intensity and interference. The BPI is a 9‐item questionnaire, which has good test‐retest reliability for pain intensity and interference, high internal consistency and good construct validity.[At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a suite of questionnaires, which will take between 30 and 45 minutes. These will be administered via paper surveys, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5‐weeks following completion of baseline measures for the control group and again at 6‐month follow‐up, participants will complete the same suite of questionnaires, as well as the GROC scale. Assessment at baseline and 5‐week follow‐up will occur at Gold Coast University Hospital. At 6‐month follow‐up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher. ] Secondary outcome 6: The effect of the UPLIFT program on patients’ self assessment of global change (compared to usual physiotherapy care) will be evaluated using the Global rating of change (GROC) score. Success of the UPLIFT program or usual care is defined as a GROC score of =+3 evaluated at immediate and 6 months follow‐up, indicates success. The boundaries of the GROC scale are: ‐5 (very much worse) and +5 (completely recovered). The GROC is recommended for use in persistent pain clinical research as a core outcome measure of global improvement with treatment[At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a suite of questionnaires, which will take between 30 and 45 minutes. These will be administered via paper surveys, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5‐weeks following completion of baseline measures for the control group and again at 6‐month follow‐up, participants will complete the same suite of questionnaires, as well as the GROC scale. Assessment at baseline and 5‐week follow‐up will occur at Gold Coast University Hospital. At 6‐month follow‐up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher. ] Secondary outcome 7 : The cost‐effectiveness of UPLIFT compared to usual physiotherapy will be evaluated in an embedded economic study. Incremental cost‐effectiveness ratio from a health system perspective, defined as the net cost of UPLIFT (including program costs and cost consequences, i.e. outpatient appointments, emergency department attendances, medical imaging, surgery, injections, prescription medication), divided by the incremental change in quality adjusted life years (QALYs). QALYs will be estimated using an area under the curve approach based on participant responses to the EuroQol 5‐domain health related quality of life utility instrument., administered at baseline and follow‐up. [QALYs will be estimated using an area under the curve approach based on participant responses to the EuroQol 5‐domain health related quality of life utility instrument., administered at baseline and 6 month follow‐up post completion of intervention.. ] Secondary Outcome 8 : A secondary analysis will be undertaken from a societal perspective and will include economic losses associated with lost productivity, sick leave and return‐to‐work/activities as well as out of pocket costs associated with receiving treatment such as transport, parking and co‐payments. Patient costs for the societal perspective will be collected using a health resource utilisation questionnaire tailored for this specific cohort of patients, with productivity losses estimated using responses to the work productivity and activity impairment questionnaire.. [The work productivity and activity impairment questionnaire will be administered at the 6 month follow up time point.. ] Secondary Outcome 9 : For the economic evaluation, a cost‐utility analysis from the perspective of the health system will be the primary analysis. A micro‐costing study will be undertaken to estimate the program costs per participant for both UPLIFT and the comparator. All cost consequences with respect to health service utilisation will be captured using administratively linked data. Specifically, for each patient linked admitted patient, outpatient, emergency department presentation and hospital costing data from Queensland state statistical services will be requested following consent from participants. Additionally, Medicare Benefits and Pharmaceutical Benefits claims data will be requested from the Commonwealth department of health. The net cost per person will be estimated and the mean cost per person in the UPLIFT cohort will be compared against the mean cost per person in the control group. Incremental utility of UPLIFT compared to usual care will be measured using quality adjusted life years (QALYs). QALYS are a summary health outcome measure that combines life years (mortality) and the qualify of the those years lived (morbidity). In order to estimate QALYs a multi‐attribute utility instrument, the EQ5D5L, will be administered at baseline and follow up. Productivity losses estimated based on responses to the work productivity and activity impairment questionnaire [The multi‐attribute utility instrument, the EQ5D5L, will be administered at baseline and follow up. All statistical data from Qld health, PBS and MBS will be collected at or following 6 month follow up post completion of intervention] PRIMARY OUTCOME: Outcome 2 : Acceptability data:( Surveys) Acceptability will be assessed both quantitatively and qualitatively, focusing on two elements: patient satisfaction with the UPLIFT program itself, and acceptability of outcome data collection measures. This will be done via a previously validated patient satisfaction survey and semi‐structured interviews with patients. ; The previously validated Short Assessment of Patient Satisfaction survey, based on a theoretic model covering the seven known dimensions of patient satisfaction with health care treatment, will be used to quantitatively assess patients’ acceptance of the UPLIFT program. An additional question will be added to this survey to measure how acceptable patients found the outcome data collection methods in this study (using a Likert‐type scale). [The survey will be administered via paper at Gold Coast University Hospital, upon program completion (5‐week follow‐up). ] Outcome 3 : Acceptability Data ( Interviews) A qualitative evaluation of patients’ acceptance of the UPLIFT program will be conducted using semi‐structured interviews with a subset of participants, purposively sampled for maximum variation in age, gender and symptom duration. A semi‐structured interview guide, which will be piloted and refined prior to study commencement, will be developed based on a theoretical framework for acceptability of healthcare interventions .. Interview data will be collected by a trained research assistant, using a conversational style of interviewing that allows patients to tell a story. [Interviews will be conducted within 1 month of completion of the UPLIFT program.] Primary outcomes: Feasibility ; outcome 1: Feasibility of conducting a full‐scale clinical trial of UPLIFT will be assessed against the following a‐priori defined criteria on recruitment, retention and intervention delivery, with recruitment feasibility success defined as 75%or more eligible patients approached for recruitment agreeing to participate, Retention success is defined as 75% or more of recruited patients remaining in study long enough for adequate outcome data to be collected; and Intervention delivery success is defined as 90% or more of patients receiving the intervention as intended. ; [Feasibility data: Number and proportion of patients recruited (from those eligible) will be documented by recruiters on a recruitment log at the time of recruitment . A participant log will be kept by researchers, detailing patient attendance at UPLIFT sessions and completion of outcome data collection after each session. Loss‐to‐follow‐up and participant withdrawals will also be noted on this log. Physiotherapists who deliver the UPLIFT program will keep an intervention delivery log, recording participant attendance at each session, topics covered and any adaptations (e.g. if any content was missed or adapted).; ] INCLUSION CRITERIA: INCLUSION CRITERIA: 1) Adults aged 18–70 years; 2) persistent LBP ( that is pain in the region between the iliac crests and the ribs that has been present for greater than 3 months); and 3) sufficient English language skills to complete questionnaires and comprehend/participate in interactive education sessions within the UPLIFT program.