Back to resultsHydrodissection as a Treatment for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrodissection
Regular Injection
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
US-guided regular injection
US-guided hydrodissection
Arm Description
US in-plane injection with corticosteroid and 1cc of lidocaine. Total of 2cc.
US in-plane injection with corticosteroid and 1cc of lidocaine, and 3cc of saline. Total of 5cc.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall Pain
The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03427983
Brief Title
Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Official Title
Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
US-guided regular injection
Arm Type
Other
Arm Description
US in-plane injection with corticosteroid and 1cc of lidocaine. Total of 2cc.
Arm Title
US-guided hydrodissection
Arm Type
Other
Arm Description
US in-plane injection with corticosteroid and 1cc of lidocaine, and 3cc of saline. Total of 5cc.
Intervention Type
Procedure
Intervention Name(s)
Hydrodissection
Intervention Description
Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.
Intervention Type
Procedure
Intervention Name(s)
Regular Injection
Intervention Description
Corticosteroid and lidocaine injection without additional saline is used as routine treatment.
Primary Outcome Measure Information:
Title
Tolerance
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical Severity of Carpal Tunnel Syndrome
Description
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.
Time Frame
6 months
Title
Overall Pain
Description
The visual analog scale will be used to assess overall pain. This is a 1-10 Likert scale.
Time Frame
6 months
Title
Additional Treatment
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Amadio, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hydrodissection as a Treatment for Carpal Tunnel Syndrome
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