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

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

• Status: Completed
• Conditions: Myofascial Pain Syndromes
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation; Device: Hot pack

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

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Birkan Sonel Tur

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional TENS; Frequency:80 Hz, duration:100 μs	Device: Transcutaneous electrical nerve stimulation; 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; Device: Hot pack; 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	Device: Transcutaneous electrical nerve stimulation; 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; Device: Hot pack; 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	Device: Transcutaneous electrical nerve stimulation; 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; Device: Hot pack; 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	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	using number	Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Pressure pain	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	using double inclinometer	Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Disability	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

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

Study record dates

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

• Keywords: Myofascial Pain Syndromes; Transcutaneous Electrical Nerve Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: 10-427-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No