The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome
January 12, 2023 updated by: Yung-Tsan Wu, Tri-Service General Hospital
The Clinical Volume Effect of Nerve Hydrodissection in Patients With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel.
Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration.
The technique of nerve hydrodissection is now commonly used for peeling the nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the nerve with ischemic damage.
However, the exact effect and interval of hydrodissection are unknown because of the lack of well-designed studies Hence, investigators design a randomized, double- blind, controlled trail to assess the therapeutic effect of ultrasound-guided nerve hydrodissection in patients with CTS.
Study Overview
Status
Completed
Conditions
Detailed Description
After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate CTS were inclused and randomized into three groups.
Group A, patients received one-session of ultrasoung-guided nerve hydrodissection with 10cc normal saline; Group B, patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; The injection syringe was covered to obscure the nature of its contents and patients were asked to turn their head away so that they would not see the procedure.
As a result, patients were blinded to the treatment condition.
The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and global assessment of treatment.
The evaluations were performed pretreatment as well as on the 2nd week, 1st, 3rd and 6th month after injecton.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Neihu District
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Taipei, Neihu District, Taiwan, 886
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 20-80 year-old.
- Diagnosis was confirmed using an electrophysiological study
Exclusion Criteria:
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- Cervical radiculopathy
- Polyneuropathy, brachial plexopathy
- Thoracic outlet syndrome
- Previously undergone wrist surgery or steroid injection for CTS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Ultrasound-guided nerve hydrodissection with 10cc normal saline
|
Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.
Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
The ultrasound was used to measure cross-sectional area and injection guidance
The normal saline was used for injection solution
|
|
Active Comparator: Group B
Ultrasound-guided nerve hydrodissection with 5cc normal saline
|
Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.
Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
The ultrasound was used to measure cross-sectional area and injection guidance
The normal saline was used for injection solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
Using the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.
BCTQ includes two subscale (11 questions in symptom severity and 8 questions in functional status).
The scores ranged from 0 to 5 points in each question, in which zero score refered to as mildest and no difficulty in activity; five scores mean most worst severity and dysfunction.
|
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline of pain on 2nd week, 1st, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
The VAS score range from 10 (tremendously harsh pain) to 0 points (no pain)
|
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
|
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
|
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
|
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd and 6th month after injection
Time Frame: Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
|
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
- Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 2015 Apr 24.
- Evers S, Thoreson AR, Smith J, Zhao C, Geske JR, Amadio PC. Ultrasound-guided hydrodissection decreases gliding resistance of the median nerve within the carpal tunnel. Muscle Nerve. 2018 Jan;57(1):25-32. doi: 10.1002/mus.25723. Epub 2017 Jul 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 21, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nerve hydrodissection for CTS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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