Your session is about to expire
← Back to Search
Behavioural Intervention
OMT + Conservative Therapy for Carpal Tunnel Syndrome (COMET-AOA Trial)
N/A
Recruiting
Led By Roland Gazaille, DO
Research Sponsored by Kettering Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to measure how the elasticity and stiffness of the median nerve change in patients with mild to moderate carpal tunnel syndrome after receiving osteopathic manipulative therapy.
Who is the study for?
This trial is for people with mild to moderate carpal tunnel syndrome, confirmed by recent EMG tests. It's open to those with the condition in one or both hands.
What is being tested?
The study measures how a type of physical therapy called osteopathic manipulative treatment (OMT) affects the stiffness and elasticity of the median nerve in patients' wrists compared to standard conservative treatments.
What are the potential side effects?
OMT may cause temporary discomfort, soreness, or bruising at the site of manipulation. Conservative treatments might include wrist splinting which can lead to skin irritation or muscle weakness from disuse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CTS-6 Evaluation Tool Score
Cross-sectional area of median nerve in 3 locations
Elasticity of median nerve at the carpal tunnel inlet
+3 moreSecondary study objectives
Motor Distal Latency
Sensory Distal Latency
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 - OMT OnlyExperimental Treatment1 Intervention
Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
Group II: Group 2 - OMT + Conservative TreatmentActive Control2 Interventions
Will receive Osteopathic manipulative treatment in addition to conservative treatment. Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen. Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
Group III: Group 3 - Conservative Treatment OnlyActive Control1 Intervention
Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen.
Find a Location
Who is running the clinical trial?
Kettering Health NetworkLead Sponsor
19 Previous Clinical Trials
1,821 Total Patients Enrolled
1 Trials studying Carpal Tunnel Syndrome
64 Patients Enrolled for Carpal Tunnel Syndrome
American Osteopathic AssociationOTHER
20 Previous Clinical Trials
3,619 Total Patients Enrolled
Roland Gazaille, DOPrincipal InvestigatorKettering Health
Share this study with friends
Copy Link
Messenger