- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645095
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
Status
Completed
Conditions
Intervention / 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.
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
-
-
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Ankara, Turkey, 06100
- Birkan Sonel Tur
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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:
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:
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:
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.
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using number
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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)
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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
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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.
Sponsor
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
Additional Relevant MeSH Terms
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
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.
Clinical Trials on Myofascial Pain Syndromes
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Bozyaka Training and Research HospitalEnrolling by invitationMyofascial Pain | Trigger Point Pain, Myofascial | Myofascial Trigger Point PainTurkey
-
Washington University School of MedicineRecruitingMyofascial Pain | Pelvic Pain | Pelvic Floor Myofascial PainUnited States
-
Beth Israel Deaconess Medical CenterMassachusetts General HospitalRecruitingMyofascial Pain | Trigger Point Pain, MyofascialUnited States
-
University of ArizonaEnrolling by invitationMyofascial Pain | Myofascial Trigger Point PainUnited States
-
Universidad Complutense de MadridCompletedMyofascial Pain | Trigger Point Pain, MyofascialSpain
-
Quiropraxia y EquilibrioUniversidad Nacional Andres BelloCompletedMyofascial Trigger Point Pain (MTrP)Chile
-
Indonesia UniversityCompletedMyofascial Pain of Upper Trapezius MuscleIndonesia
-
Washington University School of MedicineNational Center for Complementary and Integrative Health (NCCIH)Recruiting
-
Lithuanian University of Health SciencesCompleted
-
Quiropraxia y EquilibrioNot yet recruitingMyofascial Trigger Point Pain (MTrP)Chile
Clinical Trials on Transcutaneous electrical nerve stimulation
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University of L'AquilaCompleted
-
Karolinska University HospitalActive, not recruitingHip Fractures | Hip Osteoarthritis | Orthopedic Disorder | Post Operative PainSweden
-
University of Colorado, BoulderUniversity of Colorado, Denver; Colorado State UniversityWithdrawn
-
Assistance Publique - Hôpitaux de ParisCompletedTendinopathy | Cervical Radiculopathy | Post-herpetic Neuralgia | Chronic Back Pain | Limbs Arthrosis | Non Arthrosic Limbs Arthralgia | Chronic Lomboradiculalgia | Post-surgical Peripheral Neuropathic Pain | Post Trauma Neuropathic Pain | Complex Regional Pain Syndrome Type I or IIFrance
-
ADIR AssociationCompletedChronic Obstructive Pulmonary DiseaseFrance
-
University Hospital, ToulouseMinistry of Health, FranceTerminatedPeripheral Artery DiseaseFrance
-
Secretaria Municipal de Saúde de RolanteCentro Universitario La SalleUnknown
-
University of Nove de JulhoRecruiting
-
Institut Cancerologie de l'OuestTerminated
-
Vrije Universiteit BrusselUnknown