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Behavioural Intervention

Group 1 - OMT Only 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

COMET-AOA Trial 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.Check my eligibility
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.See study design
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.

COMET-AOA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CTS-6 Evaluation Tool Score
Cross-sectional area of median nerve in 3 locations
Elasticity of median nerve at the carpal tunnel inlet
+3 more
Secondary outcome measures
Motor Distal Latency
Sensory Distal Latency

COMET-AOA 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
19 Previous Clinical Trials
3,629 Total Patients Enrolled
Roland Gazaille, DOPrincipal InvestigatorKettering Health
~24 spots leftby Mar 2025
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