Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009840
NCT ID: NCT03427983
Sponsor Protocol Number: 17-009840
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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 ages 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, uncontrolled 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Peter Amadio, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available