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Tests treatment safety and results for Osteo Arthritis Knee and Hip
Official title COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL
ClinicalTrials.gov ID: NCT07532070
What this study is testing
- What it's testing
- 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.
- Time commitment: about 9 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Nevada, United States
- San Antonio, Texas, United States
- Camperdown, New South Wales, Australia
- Brisbane, Saint Lucia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Nevada, United States; San Antonio, Texas, United States; Camperdown, New South Wales, Australia; Brisbane, Saint Lucia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.