Back to resultsWhich Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Hot pack
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Myofascial Pain Syndromes, Transcutaneous Electrical Nerve Stimulation
Eligibility Criteria
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
Sites / Locations
- Birkan Sonel Tur
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Conventional TENS
Burst TENS
Modulated TENS
Arm Description
Frequency:80 Hz, duration:100 μs
Frequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz
Frequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs
Outcomes
Primary Outcome Measures
Pain intensity
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Number of trigger points in the upper back region
using number
Pressure pain
using algometer (kg/cm2)
Neck joint range of motion
using double inclinometer
Disability
using Modified Neck Disability Index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04645095
Brief Title
Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?
Official Title
Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome? A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes
Keywords
Myofascial Pain Syndromes, Transcutaneous Electrical Nerve Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional TENS
Arm Type
Active Comparator
Arm Description
Frequency:80 Hz, duration:100 μs
Arm Title
Burst TENS
Arm Type
Active Comparator
Arm Description
Frequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz
Arm Title
Modulated TENS
Arm Type
Active Comparator
Arm Description
Frequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Other Intervention Name(s)
TENS
Intervention Description
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Intervention Type
Device
Intervention Name(s)
Hot pack
Intervention Description
All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
Primary Outcome Measure Information:
Title
Pain intensity
Description
using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain
Time Frame
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Title
Number of trigger points in the upper back region
Description
using number
Time Frame
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Title
Pressure pain
Description
using algometer (kg/cm2)
Time Frame
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Title
Neck joint range of motion
Description
using double inclinometer
Time Frame
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
Title
Disability
Description
using Modified Neck Disability Index
Time Frame
Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birkan Sonel Tur, Prof.
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birkan Sonel Tur
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?
We'll reach out to this number within 24 hrs