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Comparison of Difference Hydrodissection for CTS

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound-guided short-axis hydrodissection with 5cc normal saline
Ultrasound-guided long-axis hydrodissection with 3cc 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 Hydrodissection, short-axis, long-axis

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

Short-axis hydrodissection

Long-axis hydrodissection

Arm Description

Ultrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve

Ultrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve

Outcomes

Primary Outcome Measures

Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary Outcome Measures

Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 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, 2nd, 3rd and 6th month after injection
Electrophysiological study of the median nerve before treatment and multiple time frame after treatment.
Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection
The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch

Full Information

First Posted
January 21, 2017
Last Updated
October 29, 2019
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03031041
Brief Title
Comparison of Difference Hydrodissection for CTS
Official Title
Comparison of Difference Hydrodissection Technique in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (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. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. The investigators design a randomized, double-blind, controlled trial to assess the effect of different method of ultrasound-guided hydrodissection in patients with CTS.
Detailed Description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in short-axis group received one-dose ultrasound-guided hydrodissection with short-axis approach and long-axis group received one-dose ultrasound-guided injection with long-axis approach. No additional treatment after injection through the study period. 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 finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Hydrodissection, short-axis, long-axis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Short-axis hydrodissection
Arm Type
Experimental
Arm Description
Ultrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve
Arm Title
Long-axis hydrodissection
Arm Type
Active Comparator
Arm Description
Ultrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided short-axis hydrodissection with 5cc normal saline
Intervention Description
Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided long-axis hydrodissection with 3cc normal saline
Intervention Description
Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve
Primary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Title
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 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, 2nd, 3rd and 6th month after injection
Title
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
Electrophysiological study of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
Title
Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection
Description
The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch
Time Frame
Pre-treatment, 2nd week, 1st, 2nd, 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
21234632
Citation
DeLea SL, Chavez-Chiang NR, Poole JL, Norton HE, Sibbitt WL Jr, Bankhurst AD. Sonographically guided hydrodissection and corticosteroid injection for scleroderma hand. Clin Rheumatol. 2011 Jun;30(6):805-13. doi: 10.1007/s10067-010-1653-6. Epub 2011 Jan 15.
Results Reference
background
PubMed Identifier
21623291
Citation
Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
Results Reference
background
PubMed Identifier
18809959
Citation
Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485.
Results Reference
result
PubMed Identifier
26745165
Citation
Cass SP. Ultrasound-Guided Nerve Hydrodissection: What is it? A Review of the Literature. Curr Sports Med Rep. 2016 Jan-Feb;15(1):20-2. doi: 10.1249/JSR.0000000000000226.
Results Reference
result

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Comparison of Difference Hydrodissection for CTS

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