RESTORE - Individualised movement rehabilitation and movement sensor biofeedback for chronic, disabling low back pain

INTERVENTION: Arm 1: Cognitive Functional Therapy alone CFT is a physiotherapist‐led individualised behavioural intervention for people with disabling musculoskeletal pain. Based on screening questionnaires and an extensive examination (interview and physical examination), the following unhelpful responses to pain are identified and targeted: cognitive (i.e. negative beliefs), emotional (i.e. pain related fear and distress) and behavioural (i.e. protective muscle guarding, movement, activity avoidance and poor sleep habits) responses. This targeting includes: 1. personalised biopsychosocial pain education; 2. graduated exposure to previously avoided and/or provocative movements and activities with pain control in order to re‐engage people with valued activities; and 3. lifestyle change targeting physical activity, sleep habits, stress management. Arm 2: CFT plus movement sensor biofeedback Movement sensors enable clinicians to precisely measure movement patterns, postures, back muscle activity and their relationship to pain, both in the clinical setting and during patients’ normal activities of work, rest and play. Via biofeedback, movement sensors can help patients develop an awareness of how they move and the postures they use during activities of daily living, where changes to habituated movement are most important. In this study we will use the ViMove2 clinical movement sensor system (dorsaVi P/L, Melbourne, Australia) Both CFT treatment groups (arm 1 and arm 2) will have the same treatment frequency of up to 7 treatment sessions over 12 weeks plus a ‘booster’ session at 6 months (initial consultation 60 minutes, otherwise 30‐40 minutes). In these treatment groups only, the movement sensors will be placed on the lower back region, with kinematic sensors at the thoracolumbar junction and upper sacrum, and EMG sensors paraspinally at approximately L3. Clinicians will use the ViMove2 app (Apple app store) to access the data using a version that has been modified for this study. The sensors will be worn during each treatment session and for the rest of that day. Patients in the CFT plus movement sensor biofeedback will use a modified version of the myViMove app (Apple app store) to receive biofeedback, which is so intuitive it requires little instruction. At each treatment session, adherence to the program will be assessed by the physiotherapist and barriers to program adherence will be discussed in a collaborative manner. Participants will self‐rate program adherence at 2, 6 and 12 weeks using a 0‐10 scale specifically created for this study. Physiotherapist intervention training These treatment approaches will be delivered by specially trained physiotherapists in private physiotherapy clinics in Perth and Sydney. That treating physiotherapist training, to the point of competency, will consist of up to 100 hours of workshop participation and direct clinical mentoring, supported by a treatment manual, videos, an e‐book and private Facebook discussion groups. The treatment and eBook manual are unpublished training materials specifically designed for the physiotherapists delivering the active interventions. CONDITION: Lower back pain INCLUSION CRITERIA: Participants need to meet all of the following: 1. Adult people with current low back pain that has an episode duration of more than 3 months. 2. Presented to a primary care clinician at least 6 weeks prior for this episode of low back pain. 3. Average low back pain intensity of 4 or more when rated on a 0‐10 Numerical Pain Rating Scale. 4. At least moderate pain‐related interference with normal work or daily activities (measured by item 8 of the Short Form 36 questionnaire). PRIMARY OUTCOME: For the economic (cost‐utility) analysis, the primary outcome of clinical effect will be quality‐adjusted life years calculated using the EuroQOL EQ‐5D‐5L. Economic outcomes will be measured, including direct health costs attributable to consumption of health care resources (measured using extracts from Medicare and Pharmaceutical Benefit databases and direct patient report) and productivity costs (measured using the iMTA Productivity Cost Questionnaire) at 12, 26, 40 and 52 weeks. The primary clinical outcome will be pain‐related physical activity limitation measured using the Roland Morris Disability Questionnaire. SECONDARY OUTCOME: A composite of lumbosacral movement and paraspinal muscle activity will be measured in both the Cognitive Functional Therapy treatment groups using wearable wireless sensors (DorsaVi P/L) and used in the mediation analysis. Adverse events (defined as any morbidity or events causing unwarranted distress to a participant that were potentially related to any trial‐related intervention). These will patient‐reported at every clinical and questionnaire contact. The most likely adverse event is an infrequent skin reaction to the sensor adhesive. Fear of movement (the physical activity subscale of the Fear Avoidance Beliefs Questionnaire). Pain catastrophisation (the Pain Catastrophizing Scale). Pain intensity (Numeric Pain Rating Scales). Pain self‐efficacy (the Pain Self‐efficacy Questionnaire) Patient satisfaction with care and treatment (a study specific question, 7‐point Likert scale) Patient‐perceived global improvement (the Patient Global Impression of Change question, 7‐point Likert scale) Patient‐specific activity limitation (Patient Specific Functional Scale). Therapeutic alliance will be measured using the Working Alliance/Theory of Change Inventory in the Cognitive Functional Therapy groups and used in a mediation analysis.