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Exercise + Insomnia Treatment for Knee Osteoarthritis

N/A

Recruiting

Led By Daniel Whibley, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-week (post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare if adding a personalized sleep improvement program to personalized exercise coaching helps reduce knee osteoarthritis pain more than just exercise coaching alone. The researchers think that the combination of interventions will lead

Who is the study for?

This trial is for older adults with knee osteoarthritis who also suffer from insomnia. Participants should have a confirmed diagnosis of knee osteoarthritis, moderate to severe persistent pain, and symptoms of insomnia. They must not have changed any pain or sleep medication in the last three months and agree not to change these during the study.

What is being tested?

The study tests if adding cognitive behavioral therapy for insomnia to personalized exercise coaching can better improve pain outcomes than exercise alone in those with knee osteoarthritis. The effectiveness will be measured by patient-reported pain intensity.

What are the potential side effects?

While specific side effects are not detailed here, typical side effects from cognitive behavioral therapy may include temporary increases in distress, while exercise might lead to muscle soreness or joint discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have ongoing moderate to severe knee pain from arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-week (post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-week (post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-week (post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period

Secondary study objectives

Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention)

Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention)

Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention)

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