Comparing exercise, cognitive behavioral therapy for insomnia, and both for chronic musculoskeletal pain with poor sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic low back pain or hip/knee osteoarthritis and coexisting insomnia are randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combined program. Each program includes up to 10 online consultations with a physiotherapist and tailored guidance on pain, sleep, and physical activity. Outcomes are measured at baseline, 2, 6, and 12 months using questionnaires, wearable activity and sleep monitors, sensory testing, blood samples, and sleep EEG at baseline and 6 months. The aim is to determine which non-drug lifestyle approach produces the greatest improvement in pain, sleep, physical function, and related biological markers.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA Participants will be included if they have persistent LBP defined as i) age ≥18 years; ii) sought or seriously considered care from a primary care clinician or specialist for their LBP within the past 6 weeks; iii) have at least moderate LBP-related interference with normal work or daily activity (including both work outside the home and housework), as assessed by item 8 of the 36-item Short Form Health Survey OR hip or knee OA defined by the National Institute for Health and Care Excellence as: i) age ≥45 years; ii) activity-related hip or knee joint pain; and iii) no morning hip or knee stiffness, or morning stiffness ≤30 minutes)

* 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
* Verification that participants recruited in the US are beneficiaries of the Military Health System.

EXCLUSION CRITERIA

* 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
* Waiting or planning to receive an injection in the study pain site in the next 12 months
* Had within the past 12 months, or waiting or planning surgery in the next 12 months
* Neurological or systemic conditions that may affect physical function (e.g. Parkinson's, Active cancers, multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis)
* Failing the American College of Sports Medicine pre-participation Health Screening Questionnaire without medical clearance to participate
* Unable to give informed consent and/or participate in the intervention and assessment procedures.
* Unable to speak or read English.

Where it's running

• Susan Wakil Health Building
  Camperdown, New South Wales, Australia Recruiting
• Madigan Army Medical Centre 9040A Jackson Ave Joint Base
  San Antonio, Nevada, United States Not yet recruiting
• Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston
  San Antonio, Texas, United States Not yet recruiting
• The University of Queensland Therapies Building (84A)
  Brisbane, Saint Lucia, Australia Not yet recruiting

Study contacts

• Study coordinator: Alan A Nguyen, BSc/B.A
• Email: sleepfit.trial@sydney.edu.au
• Phone: +610433014884

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.