Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome (STCCOT)

May 6, 2024 updated by: Irene Calzado Álvarez de Lara, Hospital Universitario Reina Sofia de Cordoba

Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Clinical Trial

The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. As secondary objectives, we also seek to determine if the postsurgical grip and pincer strength and the Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will be a randomized clinical trial with a sample size of about 80 patients. It will have two study groups: the experimental group (in which 40 patients will be included) where a Z-plasty technique will be applied; and the control group (another 40 patients) who will undergo the conventional technique of complete section of the transverse carpal ligament. The main variable will be the presence or absence of post-surgical pillar pain and, as secondary variables, the recovery of grip and pincer strength and the improvement in the BCTQ score will be studied.

The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs , Phalen and Tinnel positive) and with a positive electromyogram test classified as "moderate" or "severe". As inclusion criteria, patients >18 years of age with moderate-severe carpal tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed conservative treatment will be considered. Those who have already undergone a previous surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or congenital sequelae in the hand or who do not have the capacity to understand the process or the tests to be performed will be excluded.

The total expected duration of each patient in the study will be 6 months and the following visits and procedures will be carried out: clinical study and quality questionnaires prior to surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with repetition of clinical examination and quality questionnaires.

The incidence of pillar pain (defined as pain/sensation of allodynia in the area of the thenar and/or hypothenar eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, dysesthesia at rest) will be analyzed applying the principle of intention to treat, using the Mann Whitney test to compare the score in the tests used.

Study Type

Interventional

Enrollment (Actual)

120

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

  • Spain
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 years
  • Moderate-severe carpal tunnel syndrome
  • Symptoms that hinder the patient's daily activities
  • Correct conservative treatment without success

Exclusion Criteria:

  • Previous surgical intervention for carpal tunnel syndrome
  • Traumatic or congenital sequelae of the hand
  • Incompetence to understand the process and the tests to be carried out

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Z-plasty
It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.
Procedure: Z-plasty
It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.
Active Comparator: Conventional
It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
Procedure: Conventional
It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pillar Pain
Time Frame: 3 weeks after surgery
Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia
3 weeks after surgery
Incidence of Pillar Pain
Time Frame: 6 months after surgery
Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: 3 weeks after surgery
Grip strength measured with a dynamometer
3 weeks after surgery
Grip Strength
Time Frame: 6 months
Grip strength measured with a dynamometer
6 months
Pinch Strength
Time Frame: 3 weeks
Pinch strength measured with a dynamometer
3 weeks
Pinch Strength
Time Frame: 6 months
Pinch strength measured with a dynamometer
6 months
Clinical BCTQ
Time Frame: 3 weeks after surgery

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)
3 weeks after surgery
Functional BCTQ
Time Frame: 6 months

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)
6 months
Clinical BCTQ
Time Frame: 6 months

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (symptoms) of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)
6 months
Functional BCTQ
Time Frame: 3 weeks after surgery

Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (functionality; daily activities) of carpal tunnel syndrome.

Minimum: 1 (better). Maximum: 5 (worse)
3 weeks after surgery

Collaborators and Investigators

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

Sponsor

Hospital Universitario Reina Sofia de Cordoba

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)

July 18, 2022

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

May 28, 2023

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STCOT

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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