Sleep or sweat? trial tests best fix for pain and insomnia
NCT ID NCT07532070
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests three home-based programs for people with long-term muscle or joint pain (like back pain or arthritis) who also sleep poorly. Participants will be randomly assigned to 12 months of exercise, cognitive behavioural therapy for insomnia (CBT-I), or both. The goal is to see which approach best reduces pain and improves sleep, using online sessions with a physiotherapist and wearable devices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exercise and cognitive behavioural therapy for insomnia (CBT-I)
- What this could lead to
- If successful, this could point toward effective non-drug lifestyle programs to ease chronic pain and improve sleep for people with back pain or arthritis.
- What could go wrong
- This is a mid-sized trial testing behavioural interventions, not a drug. Results may vary by individual, and benefits might be modest or not last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 384 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brooke Army Medical Centre 3551 Roger Brooke Dr. Fort Sam Houston
NOT_YET_RECRUITINGSan Antonio, Texas, 78234, United States
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Madigan Army Medical Centre 9040A Jackson Ave Joint Base
NOT_YET_RECRUITINGSan Antonio, Nevada, 78234, United States
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Susan Wakil Health Building
RECRUITINGCamperdown, New South Wales, 2200, Australia
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The University of Queensland Therapies Building (84A)
NOT_YET_RECRUITINGBrisbane, Saint Lucia, 4072, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can magnetic brain zaps ease the pain of a sleepless body?
- Can poor sleep make you hurt more? study probes Insomnia's link to pain
- Radiofrequency device tested as Add-On for stubborn back pain
- Back muscles hold clues for treating recurrent low back pain
- Skip the GP? physiotherapy first for back pain put to the test
- Does soreness after exercise disrupt sleep more for people with insomnia?