Hydrodissection as a Treatment for Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT03427983|
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Procedure: Hydrodissection Procedure: Regular Injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Hydrodissection as a Treatment for Carpal Tunnel Syndrome|
|Actual Study Start Date :||March 8, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
US-guided regular injection
US in-plane injection with corticosteroid and 1cc of lidocaine. Total of 2cc.
Procedure: Regular Injection
Corticosteroid and lidocaine injection without additional saline is used as routine treatment.
US in-plane injection with corticosteroid and 1cc of lidocaine, and 3cc of saline. Total of 5cc.
Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.
- 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.
- 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.
- Overall Pain [ Time Frame: 6 months ]The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427983
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Peter C Amadio, MD||Mayo Clinic|