Skip to main content
OpenTrials
Completed

NCT Number: NCT03427983

Hydrodissection as a Treatment for Carpal Tunnel Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Hydrodissection

Procedure

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

Regular Injection

Procedure

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

Primary outcomes

  1. Tolerance

    Time frame: 6 months

    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.

Secondary outcomes

  1. Clinical Severity of Carpal Tunnel Syndrome

    Time frame: 6 months

    The Boston Carpal Tunnel Assessment questionnaire will be used to assess both symptom severity and functional status using a 19 item questionnaire with scores between values 1-5.

  2. Overall Pain

    Time frame: 6 months

    The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale.

  3. Additional Treatment

    Time frame: 6 months

    After 6 months patients will be asked whether they have had additional treatment for their Carpal Tunnel Syndrome after the ultrasound guided injection. The date, location, and time frame of the additional treatment will be recorded.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2018
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.