This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip/knee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.
An average pain of ≥4 on an 11-point numerical rating scale (NRS); 0 equals no pain, 10 equals worst pain possible over the last week
≥11 on the Insomnia Severity Index
Access to a computer/laptop/tablet with internet availability for videoconferencing consultations
Willing and able to participate in video consultations
Self-report engagement in >120 minute per week of at least moderate intensity physical activity within the past 6 months
Current or previous engagement in CBT-I in the past 6 months
Cognitive impairment (based on ≥7 on the Short Orientation Memory Concentration Test
Received an injection of any substance into the study pain site in the previous 3 months
Parallel
Aerobic physical activity
BehavioralThis intervention consists of a structured, individualised aerobic physical activity program delivered via videoconferencing by a physiotherapist. The program focuses exclusively on aerobic-based activities and does not include any sleep-specific or cognitive behavioural components. Exercise prescription will be tailored and progressively adjusted based on participant tolerance, goals, and clinical guidelines.
CBT-I
BehavioralThis intervention consists of cognitive behavioural therapy for insomnia (CBT-I) delivered via videoconferencing by a physiotherapist trained in CBT-I principles. The program targets sleep-related behaviours and cognitions using evidence-based CBT-I strategies, including sleep restriction, stimulus control, cognitive restructuring, and sleep hygiene education. No structured physical activity or exercise prescription is included.
Combined aerobic physical activity and CBT-I
BehavioralThis intervention integrates both a structured aerobic physical activity program and cognitive behavioural therapy for insomnia (CBT-I) within the same physiotherapist-delivered videoconferencing consultations. Participants receive both aerobic physical activity alongside CBT-I strategies targeting sleep behaviours and cognitions. The combined intervention delivers both components concurrently and differs from the single-component interventions by addressing physical aerobic activity and sleep within an integrated treatment framework.
Average Pain severity
Average pain severity at the designated study site will be measured using a 0-10 Numerical Rating Scale, with higher scores indicating greater pain. Assessments will be conducted at baseline and at 2, 6, and 12 months. Primary intervention efficacy will be evaluated by between-group differences in change in average NRS pain from baseline to 6 months.
Worst pain severity
Worst pain severity at the designated study site over the past week will be assessed using the numeric rating scale, ranging from 0 ("no pain") to 10 ("worst pain possible").
Pain interference (PROMIS Short Form 8a)
Scored using 8 questions (5-point Likert Scale) related to the consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities in the past 7 days. 5-point Likert scale. Ranges from 0-10; where 0 = 'no pain' and 10 = 'worst pain possible'
Health-related quality of life (EQ-5D-5L)
Scored using 5 items (5-point Likert Scale) about mobility, self-care, pain, usual activities, and psychological status over the past week, with a Likert scale ranging from no problem to extreme pain or discomfort.Score ranges from 0 to 100. Higher scores indicate a better quality of life.
Insomnia (Insomnia Severity Index)
Scored using a 7-items (5-point Likert scale) that captures disturbances in sleep consistent with insomnia. Score ranges 0 to 28. Higher scores indicating greater insomnia severity.
Physical activity
Time spent in at least moderate intensity activity per week using a wrist-worn wearable. Time (minutes)
Psychological (Orthopaedic Physical Therapy Investigators Network Yellow Flag (10-items)
Scored using 10-item (various point Likert scales) about psychological distress (e.g. negative mood, fear-avoidance and positive coping). Ranging from 0 to 11 "yellow flags". Higher number indicates more yellow flags.
Physiological sleep
Sleep efficiency (wearable). Time asleep relative to time in bed
Medication use
Self-reported using customised survey. Will report the number or percentage of participants for each type of medication.
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University of Sydney
Lead sponsor
The University of Queensland
Collaborator
Uniformed Services University of the Health Sciences
Collaborator
