Status:

COMPLETED

Hydrodissection as a Treatment for Carpal Tunnel Syndrome

Lead Sponsor:

Mayo Clinic

Conditions:

Carpal Tunnel Syndrome

Eligibility:

All Genders

21-80 years

Phase:

NA

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 p...

Eligibility Criteria

Inclusion

  • 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

  • Exclusion criteria are largely based on the premises of only including patients with idiopathic carpal tunnel syndrome without expected interferences of the acquisition of the ultrasound images or corticosteroid treatment.
  • 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

Key Trial Info

Start Date :

March 8 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2019

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03427983

Start Date

March 8 2018

End Date

July 31 2019

Last Update

August 14 2019

Active Locations (1)

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Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905