Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?

November 23, 2020 updated by: Birkan Sonel Tur, Ankara University

Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome? A Randomized Controlled Trial

The aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment.

Study Overview

Detailed Description

Myofascial pain syndrome (MAS) is a regional pain syndrome characterized by trigger points detected by one or several muscle groups and reflected pain manifestation caused by palpation of these points. Transcutaneous electrical nerve stimulation (TENS) is a physical therapy modality that provides an analgesic effect by delivering a controlled low voltage electrical current to the nervous system through electrodes placed on the skin. Knowledge on how modulation parameters such as frequency, wave width and form alter TENS activity are limited.

Study Type

Interventional

Enrollment (Actual)

101

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

      • Ankara, Turkey, 06100
        • Birkan Sonel Tur

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having a diagnosis of myofascial pain syndrome according to the criteria defined by Travell and Simons

Exclusion Criteria:

  • The onset of symptoms is less than 3 months
  • Severe cervical disc hernia, radiculopathy or myelopathy
  • Stage 3-4 cervical degeneration
  • Tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease
  • Cardiac pacemaker
  • Diagnosed with fibromyalgia syndrome
  • Kyphoscoliosis
  • Acute trauma history
  • Having had previous brain or shoulder surgery
  • Injections for MAS and / or physiotherapy programs in the last 3 months
  • Pregnancy

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional TENS
Frequency:80 Hz, duration:100 μs
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Other Names:
  • TENS
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Active Comparator: Burst TENS
Frequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Other Names:
  • TENS
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Active Comparator: Modulated TENS
Frequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Other Names:
  • TENS
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Number of trigger points in the upper back region
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using number
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Pressure pain
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using algometer (kg/cm2)
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Neck joint range of motion
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using double inclinometer
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Disability
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
using Modified Neck Disability Index
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Birkan Sonel Tur, Prof., Ankara University

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)

May 5, 2017

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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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