Hydrodissection in Carpal Tunnel Syndrome

December 18, 2023 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Comparing Efficacy of Hydrodissection With Hyaluronic Acid vs 5% Dextrose for Carpal Tunnel Syndrome: A Randomized Controlled Trial and Ultrasonographic Evaluation of Median Nerve Gliding

Compare the efficacy on carpal tunnel syndrome (CTS) treatment between hydrodissection with hyaluronic acid (HA) vs 5% dextrose

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Compare the efficacy on carpal tunnel syndrome treatment between hydrodissection with hyaluronic acid vs 5% dextrose through ultrasonographic evaluation.; 2) Evaluate the association of median nerve gliding results between using duplex Doppler ultrasound and B mode video with cross-correlation algorithm.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 231
        • Recruiting
        • Department of Physical Medicine and Rehabilitation, Taipei Tzu chi Hospital, Buddhist Tzu chi Medical Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 20-80 years old patients with carpal tunnel syndrome

Exclusion Criteria:

  • pregnancy, Diabetes, hypothyroidism, uremia, rheumatoid arthritis, coagulopathy, cervical radiculopathy and patients who has ever received surgery for carpal tunnel syndrome or wrist fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid group
Hyaluronic acidwas injected under ultrasound guidance around wrist median nerve
Procedure: Ultrasound guided median nerve hydrodissection injection with Hyaluronic acid
Hyaluronic acid was injected under ultrasound guidance around median nerve at the wrist
Active Comparator: Dextrose group
Dextrose was injected under ultrasound guidance around wrist median nerve
Procedure: Ultrasound guided median nerve hydrodissection injection with Dextrose water
Dextrose water was injected under ultrasound guidance around median nerve at the wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston CTS (carpal tunnel syndrome) questionnaire
Time Frame: before injection , 2 weeks, 3 months and 6 months after injection.
The Boston CTS questionnaire is self-administered and is composed of two parts: the symptom severity scale (11 questions) and the functional status scale (8 questions).A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.
before injection , 2 weeks, 3 months and 6 months after injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonography (B mode) of median nerve
Time Frame: before injection , 2 weeks, 3 months and 6 months after injection.
Transverse ultrasonograms were obtained at the level of pisiform bone. Using electronic calipers, the CSA of the median nerve was measured by tracing the margin of the inner border of the perineural hyperechogenic rim that surrounded the hypoechoic median nerve , unit : mm2
before injection , 2 weeks, 3 months and 6 months after injection.
Ultrasonography (duplex Doppler) of median nerve
Time Frame: before injection , 2 weeks, 3 months and 6 months after injection.
An ultrasonography probe was placed longitudinally at the level of the lunate-capitate intercarpal joint to obtain a clear image of the median nerve. Longitudinal gliding excursions of the median nerve and flexor tendon were recorded using Doppler ultrasonography. The saved images were transferred to a personal coputer and analyzed by a researcher who was unaware of the individual and group identity of each image
before injection , 2 weeks, 3 months and 6 months after injection.
Nerve conduction study (NCS) of median nerve
Time Frame: before injection , 3 months and 6 months after injection.
Distal motor latencies of the median and ulnar nerve were respectively measured by placing a stimulating electrode at the wrist and a recording electrode 8 cm away from the stimulating electrode on the abductor pollicis brevis muscle and the adductor digiti minimi muscle. For sensory NCSs of the median and ulnar nerves, a standard distance of 14 cm was maintained between the stimulating electrode at the wrist and the recording electrodes at the ring finger on radial and ulnar sides
before injection , 3 months and 6 months after injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCRD-TPE-112-20(1/2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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