Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

November 6, 2023 updated by: Onur Armağan, Eskisehir Osmangazi University

The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial

The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)

Exclusion Criteria:

  • Secondary entrapment neuropathies
  • Cervical radiculopathy
  • Systemic diseases with increased risk of the carpal tunnel syndrome
  • Gained surgical relief of the syndrome
  • Treated with ultrasound for the syndrome
  • A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months
  • Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasound
ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2
Device: ultrasound
a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions
Experimental: pulsed ultrasound
pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4
Device: pulsed ultrasound
a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions
Placebo Comparator: placebo ultrasound
placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output
Device: placebo ultrasound
same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Symptom Severity With Symptom Severity Scale
Time Frame: three weeks
Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases.
three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain With Visual Analogue Scale
Time Frame: Three weeks
Post treatment comparison of Visual Analogue Scale between three groups min score is 0, maximum score is 10. The clinic of patient worses when the score increases.
Three weeks
Change From Baseline in Functional Status With Functional Status Scale
Time Frame: Three weeks
Post treatment comparison of Functional Status Scale between three groups min score is 8, maximum score is 40. The clinic of patient worses when the score increases.
Three weeks
Changes From Baseline Nervus Medianus Motor Conduction Velocity
Time Frame: Three weeks
Post treatment comparison of Median motor nerve conduction velocity between three groups
Three weeks

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Investigators

  • Study Director: Onur ARMAGAN, ass. prof., Eskisehir Osmangazi University

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

October 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (Estimated)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • clinics-2013-0627

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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