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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 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)

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.

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are 60 years old and above eligible to participate in this medical study?

"To meet the requirements for participation in this clinical trial, individuals must be at least 18 years old and no older than 65 years old."

Answered by AI

Are researchers currently enrolling participants for this trial?

"Indeed, information available on clinicaltrials.gov confirms that this particular clinical study is actively seeking participants. The trial was initially listed on February 26th, 2024 and underwent its latest revision on March 25th, 2024. Enrollment is underway for a total of 36 patients across one designated site."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, clinicaltrials.gov indicates that recruitment is ongoing for this particular trial. The study was initially listed on February 26th, 2024 and last revised on March 25th, 2024. Enrollment of approximately 36 participants will take place at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study Evaluating the Elasticity and Shear Wave Modulus (Stiffness) of the Median Nerve in Patients With Mild to Moderate Idiopathic Carpal Tunnel Syndrome Receiving OMT and Conservative Therapy

2024. "Pilot Study Evaluating the Elasticity and Shear Wave Modulus (Stiffness) of the Median Nerve in Patients With Mild to Moderate Idiopathic Carpal Tunnel Syndrome Receiving OMT and Conservative Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06150443.

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