About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aerobic physical activity
- CBT-I
- Combined aerobic physical activity and CBT-I
Treatment groups
Sponsors and collaborators
University of Sydney
Lead sponsor
The University of Queensland
Collaborator
Uniformed Services University of the Health Sciences
Collaborator