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The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound-guided nerve hydrodissection
Ultrasound-guided nerve hydrodissection
Ultrasound
Normal saline
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring nerve hydrodissection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Ultrasound-guided nerve hydrodissection with 10cc normal saline

Ultrasound-guided nerve hydrodissection with 5cc normal saline

Outcomes

Primary Outcome Measures

Change from baseline of severity of symptoms and functional status on 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.

Secondary Outcome Measures

Change from baseline of pain on 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)
Change from baseline of cross-sectional area of the median nerve on 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.
Change from baseline of conduction velocity, amplitude of median nerve on 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.

Full Information

First Posted
December 18, 2017
Last Updated
January 12, 2023
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03381521
Brief Title
The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome
Official Title
The Clinical Volume Effect of Nerve Hydrodissection in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
nerve hydrodissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Ultrasound-guided nerve hydrodissection with 10cc normal saline
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Ultrasound-guided nerve hydrodissection with 5cc normal saline
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided nerve hydrodissection
Intervention Description
Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided nerve hydrodissection
Intervention Description
Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
The ultrasound was used to measure cross-sectional area and injection guidance
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
The normal saline was used for injection solution
Primary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd and 6th month after injection
Description
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.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st, 3rd and 6th month after injection
Description
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)
Time Frame
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
Title
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd and 6th month after injection
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection
Title
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd and 6th month after injection
Description
Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd and 6th month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28778254
Citation
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.
Results Reference
result
PubMed Identifier
25932413
Citation
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.
Results Reference
result
PubMed Identifier
28622409
Citation
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.
Results Reference
result

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The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

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