Carpal Tunnel Syndrome
Conditions
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.
Interventions
PROCEDUREHydrodissection
Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.
PROCEDURERegular Injection
Corticosteroid and lidocaine injection without additional saline is used as routine treatment.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Severity of Carpal Tunnel Syndrome | 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. |
| Overall Pain | 6 months | The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale. |
| Additional Treatment | 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. |
Countries
United States
Outcome results
None listed