Functional Recovery and Pain Reduction Post-hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome (Hydrocarpal) (hydrocarpal)

January 3, 2025 updated by: Roberto Carlos Pech Arguelles, Instituto Mexicano del Seguro Social

Effectiveness in Functional Recovery and Pain Reduction Following Hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome

This study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, longitudinal, randomized in two groups clinical study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS, evaluated initially and at 4 and 12 weeks.

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • Mexico
    • Yucatán
      • Merida, Yucatán, Mexico, 97155
        • Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.

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:

  • men and women ≥18 years of age,
  • members referred to and treated at the Physical Medicine and Rehabilitation Service of HGR N°1, IMSS Mérida Yucatán, and who had a clinical or electrophysiological diagnosis of carpal tunnel syndrome.

Exclusion Criteria:

  • included a clinical or electrophysiological diagnosis of radiculopathy, plexopathy, polyneuropathy, or other peripheral neuropathy;
  • current diagnosis of cancer, coagulopathy, thoracic outlet syndrome;
  • active infectious process or current fracture in the thoracic limb;
  • previous surgery for carpal tunnel release;
  • inability to cooperate with filling out scales, physical examination, or infiltration, as clearly detailed.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Only Rehabilitation
Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then te patients were enroled to a 15-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.
Other: Physiotherapy
5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.
Experimental: Median nerve ultrasound guided hidrodissection + rehabilitation

Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then an ultrasound guided hidrodissection of the median nerve with 4.5ml of glucosade solution was performed.

The patients were enrolled into 15-20 sessions in rehabilitation área with the same protocolo of the control group.
Other: Physiotherapy
5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.
Procedure: hydrodissection of median nerve
Ultrasound guided hydrodissection of median nerve in carpal tunnel with 5% dextrose solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function
Time Frame: Initially, 4 and 12 weeks.
Boston´s carpal tunnel questionnaire results, where each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function.
Initially, 4 and 12 weeks.
Pain
Time Frame: Initially, 4 and 12 weeks.
Visual Analogue Scale (VAS) is a pain intensity measurement tool that uses a 10 cm line with two end points to indicate no pain and worst possible pain.
Initially, 4 and 12 weeks.

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

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

Helpful Links

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)

August 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2023-3201-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All IPD collected throughout the trial, only IPD used in the results publication

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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