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The Effect of Hydrodissection for Carpal Tunnel Syndrome

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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

Tracking Information
First Submitted Date  ICMJE December 9, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date August 2, 2018
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date April 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Change from baseline of pain on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd and 3rd month after injection ]
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Change History Complete list of historical versions of study NCT02991001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd and 3rd month after injection ]
    Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.
  • 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 and 3rd 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 and 3rd month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd and 3rd month after injection ]
    Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
  • Change from baseline of finger pinch on 2nd week, 1st, 2nd and 3rd month after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 2nd and 3rd 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Hydrodissection for Carpal Tunnel Syndrome
Official Title  ICMJE The Effect of Hydrodissection for Patients With Carpal Tunnel Syndrome
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Procedure: Ultrasound-guided hydrodissection
    Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
  • Procedure: Placebo ultrasound-guided injection
    Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel
  • Device: Ultrasound
  • Drug: Normal Saline
Study Arms  ICMJE
  • Experimental: Normal saline hydrodissection
    Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
    Interventions:
    • Procedure: Ultrasound-guided hydrodissection
    • Device: Ultrasound
    • Drug: Normal Saline
  • Placebo Comparator: Normal saline
    Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
    Interventions:
    • Procedure: Placebo ultrasound-guided injection
    • Device: Ultrasound
    • Drug: Normal Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
20
Actual Study Completion Date  ICMJE April 15, 2018
Actual Primary Completion Date April 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02991001
Other Study ID Numbers  ICMJE Hydrodissection for CTS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Yung-Tsan Wu, Tri-Service General Hospital
Study Sponsor  ICMJE Tri-Service General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
PRS Account Tri-Service General Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP