- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04904367
Deep Tissue Massage in the Myofascial Pain Syndrome
May 26, 2021 updated by: Ömer Bingölbali
The Effectiveness of Deep Tissue Massage on Pain, Trigger Point, Disability, Range of Motion and Quality of Life in Individuals With Myofascial Pain Syndrome
This study aims to examine the effect of deep tissue massage (DTM) on myofascial trigger point (MTrP) number, neck range of motion (ROM), pain, disability and quality of life in patients with Myofacial pain syndrome (MPS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A total of 88 patients with MPS were screened for eligibility. Of these patients, 80 who met the inclusion criteria were randomly divided into two groups using randomization with computer-generated random numbers as the control group (n=40) and DTM group (n=40).
The patients were evaluated at baseline (Day 0), and the end of treatment (Week 4).
Study Type
Interventional
Enrollment (Actual)
80
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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Güzeltepe District
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Muş, Güzeltepe District, Turkey, 49100
- Muş Alparslan University
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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
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being over the age of 18
- Have at least one active trigger point
- Have not previously undergone local injectable anesthetic blockage or acupuncture,
- Complaining of pain for the last three months
- Getting a diagnosis of MPS
Exclusion Criteria:
- Patients with infectious skin disease,
- Using analgesic and antidepressant medication,
- A history of major trauma or surgical intervention,
- Mini Mental State Examination (MMSE) score ≤ 24 according
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: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Deep tissue massage
For 4 weeks 20 session, this groups were applied hot pack with 20 minutes of conventional Transcutaneous Electrical Nerve Stimulation(TENS) to back and neck region, followed by 4 minutes of ultrasound at a frequency of 3 Megahertz(MHz) and at a dosage of 1 w / cm2.
Also, administered DTM to the back and neck region for 20 min in 12 sessions in addition to the conventional physical therapy.
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The amount of pressure during the massage was adjusted by the physiotherapist with reference to muscle tissue palpation in the patients.
During the massage, olecranon, pisiform bone protrusion, metacarpophalangeal and proximal interphalangeal joint faces forearm, wrist and fingers were used during the massage to reach deep tissue.
As a massage technique, compression and stretching techniques are used in combination.
For 4 weeks 20 session, this group were applied hot pack with 20 minutes of conventional TENS to back and neck region, followed by 4 minutes of ultrasound at a frequency of 3 MHz and at a dosage of 1 w / cm2.
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EXPERIMENTAL: Conventional physiotherapy
For 4 weeks 20 session, this groups were applied hot pack with 20 minutes of conventional TENS to back and neck region, followed by 4 minutes of ultrasound at a frequency of 3 MHz and at a dosage of 1 w / cm2.
|
For 4 weeks 20 session, this group were applied hot pack with 20 minutes of conventional TENS to back and neck region, followed by 4 minutes of ultrasound at a frequency of 3 MHz and at a dosage of 1 w / cm2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in neck pain on the 10-point Visual Analog Scale(VAS) at 4 week
Time Frame: Baseline and 4 week
|
The severity of neck pain was assessed using the visual analog scale (VAS) consists of scores from 0 to 10 in a horizontal line of 10 cm.
Patients are asked to mark a place on the scale according to the pain they feel.
Increased VAS scores indicate increased pain.
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Baseline and 4 week
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Change from baseline in quality of life on the 36-point Short-Form 36(SF-36) at 4 week
Time Frame: Baseline and 4 week
|
Short form-36 (SF-36) was used to determine the quality of life.
SF-36, which has a generic scale feature and provides wide angle measurement among the quality of life scales; Ware et al.
It was developed and put into use in 1993.
The scale includes items including perception of change in health in the last four weeks and perception of change in health in the last week.
SF-36 Turkish validity and reliability study has been done.
While the increase in the score negatively affects the body pain, physical and emotional role, it positively affects the parameters of physical function, vitality/energy, general health, mental health and social functioning.
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Baseline and 4 week
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Change from baseline in disability on the 20-point at 4 week Neck Pain and Disability Scale (NPDS) at 4 week
Time Frame: Baseline and 4 week
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The Neck Pain and Disability Scale (NPDS) was used for the assessment of disability.
This scale was developed by Wheeler et al.
NPDS is a 20-item questionnaire developed using VAS as a template.
The questions investigate the intensity of pain and its interaction with professional, recreational and functional aspects of life, and the presence and extent of emotional factors related to these.
The scoring of each question varies between 0-5.
The range of points people can get varies between 0-100.
High score values indicate severe disability in patients.
NPDS is an index has Turkish reliability and validity, consisting of 20 questions and each question scored between 0 and 5. Increased NPDS scores indicate increased disability.
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Baseline and 4 week
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Change from baseline in range of motion on the universal goniometer at 4 week
Time Frame: Baseline and 4 week
|
A universal goniometer was used to evaluate the active neck range of motion (ROM) of the patients.
The universal goniometer consists of a pivot point and two arms, fixed and movable.
The fixed arm is kept fixed to the immobile part of the extremity or to the floor or body where the measurement is made.
The movable arm is the arm that follows and makes the measurement throughout the movement of the measured joint.
During our measurement, we chose the pivot point to be the acromion, the earlobe alignment for the movable arm and the fixed arm to be parallel to the ground.
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Baseline and 4 week
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Change from baseline in number of trigger points on the manual palpation at 4 week
Time Frame: Baseline and 4 week
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Manual palpation of the trapezius and levator scapula muscles was performed by a trained physiotherapist in this field to assess the presence of MTrP.
Palpation always bilateral was performed with the third and second fingers of each hand with a pressure of no more than 4 kg, which is the conventional approach for detecting tender and trigger points.
We considered the pressure of more than 4 kg as whitening of the nail.
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Baseline and 4 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ömer BİNGÖLBALİ, Master, Mus Alparslan Universtiy
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
- Romanowski MW, Spiritovic M, Rutkowski R, Dudek A, Samborski W, Straburzynska-Lupa A. Comparison of Deep Tissue Massage and Therapeutic Massage for Lower Back Pain, Disease Activity, and Functional Capacity of Ankylosing Spondylitis Patients: A Randomized Clinical Pilot Study. Evid Based Complement Alternat Med. 2017;2017:9894128. doi: 10.1155/2017/9894128. Epub 2017 Aug 6.
- Kaye AD, Kaye AJ, Swinford J, Baluch A, Bawcom BA, Lambert TJ, Hoover JM. The effect of deep-tissue massage therapy on blood pressure and heart rate. J Altern Complement Med. 2008 Mar;14(2):125-8. doi: 10.1089/acm.2007.0665.
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)
January 1, 2019
Primary Completion (ACTUAL)
May 22, 2021
Study Completion (ACTUAL)
May 22, 2021
Study Registration Dates
First Submitted
May 21, 2021
First Submitted That Met QC Criteria
May 26, 2021
First Posted (ACTUAL)
May 27, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2021
Last Update Submitted That Met QC Criteria
May 26, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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