ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Hydrodissection for Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02991001
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : August 2, 2018
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. 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 trail to assess the effect after ultrasound-guided hydrodissection in patients with CTS.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Ultrasound-guided hydrodissection Procedure: Placebo ultrasound-guided injection Device: Ultrasound Drug: Normal Saline Not Applicable

Detailed Description:
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), 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 and 3rd month after the treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Hydrodissection for Patients With Carpal Tunnel Syndrome
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 15, 2018


Arm Intervention/treatment
Experimental: Normal saline hydrodissection
Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
Procedure: Ultrasound-guided hydrodissection
Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.

Device: Ultrasound
Drug: Normal Saline
Placebo Comparator: Normal saline
Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
Procedure: Placebo ultrasound-guided injection
Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel

Device: Ultrasound
Drug: Normal Saline



Primary Outcome Measures :
  1. Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd and 3rd 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 :
  1. Change from baseline of pain on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 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.

  2. Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 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.

  3. Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection ]
    Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.

  4. Change from baseline of finger pinch on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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): NCT02991001


Locations
Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
Responsible Party: Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02991001     History of Changes
Other Study ID Numbers: Hydrodissection for CTS
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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:
Hydrodissection

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel 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