Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

May 15, 2023 updated by: Damla Yürük, Diskapi Teaching and Research Hospital

Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome

The aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. Wrist splint is the first-line treatment option for CTS. Pulsed radiofrequency therapy is used in the treatment of chronic pain.

60 carpal tunnel syndrome patients diagnosed with electroneuromyelography will be included in the study. 30 patients will wear wrist splints for 1 month. In the other 30 patients, pulsed radiofrequency current will be given through the wrist median nerve trace. RF current will be applied through transcutaneous pads. It will be applied once a week for a total of 2 sessions, 8 minutes each. Boston carpal tunnel syndrome questionnaire with visual analog scale (VAS) will be applied to all patients before and after the treatment at 1 week and 1 month.

Our aim is to compare the effectiveness of wrist splint and pulsed rf therapy.

Study Type

Interventional

Enrollment (Anticipated)

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 Locations

  • Turkey
    • Dişkapi
      • Ankara, Dişkapi, Turkey
        • Diskapi Yildirim Beyazıt Teaching and Research Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Carpal tunnel syndrome detected by electroneuromyography
  • Positive Tinel sign

Exclusion Criteria:

  • Thenar muscle atrophy
  • Weakness in the abductor pollicis brevis muscle

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Wrist splint group
The group to be treated with a wrist splint
Device: Wrist splint
A wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve.
Active Comparator: Transcutaneous pulsed RF group
The group to be treated with transcutaneous pulsed RF
Other: Pulsed radiofrequency current
Pulsed rf current is delivered to the median nerve trace via transcutaneous pads. Pain expression is suppressed in the dorsal horn of the spinal cord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4
Time Frame: Baseline, Week 2 and 4
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "0=no pain" and "10=worst pain.
Baseline, Week 2 and 4
Boston Carpal Tunnel Syndrome Questionnaire before treatment
Time Frame: Before treatment

The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.

ıncluding Symptom Severity Scale is 11: no symptoms, 55: worst symptoms and Functional Disability Scale (FDS) no difficulties:8, worst difficulties: 40
Before treatment

Collaborators and Investigators

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

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Study Chair: mehlika panpallı ateş, Diskapi TRH
  • Study Director: ömer taylan akkaya, Diskapi TRH
  • Study Chair: Hüseyin Alp Alptekin, Diskapi TRH

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, 2021

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carpal Tunnel Syndrome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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