Hydrodissection as a Treatment for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Hydrodissection as a Treatment for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427983
• Other study ID #: 17-009840
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Hydrodissection
Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.
• Regular Injection
Corticosteroid and lidocaine injection without additional saline is used as routine treatment.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Severity of Carpal Tunnel Syndrome	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.	6 months
Secondary	Overall Pain	The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale.	6 months
Secondary	Additional Treatment	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.	6 months