Clinical trial NCT03427983: Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Official title: Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tolerance
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Severity of Carpal Tunnel Syndrome
timeFrame: 6 months
measure: Overall Pain
timeFrame: 6 months
measure: Additional Treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Peter C Amadio, MD
role: PRINCIPAL_INVESTIGATOR
References: