Hydrodissection as a Treatment for Carpal Tunnel Syndrome

NCT03427983 | Completed

• 1 other identifier: 17-009840
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Tolerance

  Acquire data on the added value of hydrodissection when using injection as a treatment for patients with Carpal Tunnel Syndrome (CTS). Questionnaires will be used to assess level of tolerance using a 10 point Likert Scale.

  6 months

Secondary Outcomes (3)

• Clinical Severity of Carpal Tunnel Syndrome

  6 months

• Overall Pain

  6 months

• Additional Treatment

  6 months

Study Arms (2)

US-guided regular injection

OTHER

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

Procedure: Regular Injection

US-guided hydrodissection

OTHER

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

Procedure: Hydrodissection

Interventions

Hydrodissection PROCEDURE

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

US-guided hydrodissection

Regular Injection PROCEDURE

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

US-guided regular injection

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Peter C Amadio, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 9, 2018
• Study Start: March 8, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)