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Trial record 75 of 337 for:    Charcot Marie Tooth

The Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03381521
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Ultrasound-guided nerve hydrodissection Device: Ultrasound Drug: Normal saline Not Applicable

Detailed Description:
After obtaining written informed consent, 60 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; Group C (control group), patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline at subcutaneous layer beyond carpal tunnel. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Efficacy of Nerve Hydrodissection in Patients With Carpal Tunnel Syndrome
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Experimental: Group A
Ultrasound-guided nerve hydrodissection with 10cc normal saline
Procedure: Ultrasound-guided nerve hydrodissection
Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.

Device: Ultrasound
The ultrasound was used to measure cross-sectional area and injection guidance

Drug: Normal saline
The normal saline was used for injection solution

Active Comparator: Group B
Ultrasound-guided nerve hydrodissection with 5cc normal saline
Procedure: Ultrasound-guided nerve hydrodissection
Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.

Device: Ultrasound
The ultrasound was used to measure cross-sectional area and injection guidance

Drug: Normal saline
The normal saline was used for injection solution

Placebo Comparator: Group C
Ultrasound-guided nerve hydrodissection with 5cc normal saline
Procedure: Ultrasound-guided nerve hydrodissection
Ultrasound-guided nerve hydrodissection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

Device: Ultrasound
The ultrasound was used to measure cross-sectional area and injection guidance

Drug: Normal saline
The normal saline was used for injection solution




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03381521


Contacts
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Contact: Yung-Tsan Wu, MD 886-2-87923311 ext 17068 crwu98@gmail.com

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
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Responsible Party: Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03381521     History of Changes
Other Study ID Numbers: Nerve hydrodissection for CTS
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
nerve hydrodissection
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries