Hydrodissection as a Treatment for Carpal Tunnel Syndrome

NCT ID: NCT03427983

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2019-07-31

Brief Summary

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This is a pilot study designed to acquire data on the added value of hydrodissection when using a corticosteroid injection as a treatment for patients with carpal tunnel syndrome. Hydrodissection is part of a standard clinical care injection under ultrasound guidance in which the fluid is used to separate the nerve from surrounding structures.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized blinded study looking at two different ways of drug administration rather than the drug itself. We will compare ultrasound guided injection with hydrodissection to ultrasound guided injection without hydrodissection. In both groups, the active drug is the same in type and amount.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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US-guided regular injection

US in-plane injection with corticosteroid and 1cc of lidocaine. Total of 2cc.

Group Type OTHER

Regular Injection

Intervention Type PROCEDURE

Corticosteroid and lidocaine injection without additional saline is used as routine treatment.

US-guided hydrodissection

US in-plane injection with corticosteroid and 1cc of lidocaine, and 3cc of saline. Total of 5cc.

Group Type OTHER

Hydrodissection

Intervention Type PROCEDURE

Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.

Interventions

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Hydrodissection

Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.

Intervention Type PROCEDURE

Regular Injection

Corticosteroid and lidocaine injection without additional saline is used as routine treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical CTS diagnosis with indication for steroid injection as determined by attending physician (if both hands are involved, only the side with the most severe CTS as indicated by electromyography (EMG) will be included) AND
* adult men and women between age 21 and 80 AND
* no more than moderate severity as indicated by EMG AND
* symptoms of numbness or tingling for at least 4 weeks in the median nerve distribution area AND
* classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram AND
* ability to complete English-language questionnaires and clinical evaluations AND
* is reachable by phone for the follow up contact

Exclusion Criteria

* Previous Carpal Tunnel Release (CTR) or other volar wrist surgery on the study hand OR known tumor/mass OR deformity of the study hand/wrist OR
* previous history of steroid injection into carpal tunnel OR
* currently taking a steroid medication either regularly or on an as needed basis OR
* any of the following clinical diagnoses or conditions: Cervical radiculopathy; rheumatoid or other inflammatory arthritis, including gout; osteoarthritis in the wrist; renal failure; sarcoidosis; peripheral nerve disease; diabetes, thyroid disease or other metabolic disorder; pregnancy; amyloidosis; or major trauma (fractures or complete ligamentous tears) to the ipsilateral arm OR
* prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Peter C. Amadio, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter C Amadio, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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17-009840

Identifier Type: -

Identifier Source: org_study_id

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