Back to resultsDeep Tissue Massage in the Myofascial Pain Syndrome
Primary Purpose
Massage Therapy, Myofascial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deep tissue massage
Conventional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Massage Therapy focused on measuring Myofascial pain syndrome, Neck disability, Pain, Quality of life
Eligibility Criteria
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
Sites / Locations
- Mus Alparslan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Deep tissue massage
Conventional physiotherapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in neck pain on the 10-point Visual Analog Scale(VAS) at 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.
Change from baseline in quality of life on the 36-point Short-Form 36(SF-36) at 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.
Change from baseline in disability on the 20-point at 4 week Neck Pain and Disability Scale (NPDS) at 4 week
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.
Change from baseline in range of motion on the universal goniometer at 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.
Change from baseline in number of trigger points on the manual palpation at 4 week
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904367
Brief Title
Deep Tissue Massage in the Myofascial Pain Syndrome
Official Title
The Effectiveness of Deep Tissue Massage on Pain, Trigger Point, Disability, Range of Motion and Quality of Life in Individuals With Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 22, 2021 (Actual)
Study Completion Date
May 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ömer Bingölbali
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
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage Therapy, Myofascial Pain Syndrome
Keywords
Myofascial pain syndrome, Neck disability, Pain, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep tissue massage
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional physiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Deep tissue massage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in neck pain on the 10-point Visual Analog Scale(VAS) at 4 week
Description
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.
Time Frame
Baseline and 4 week
Title
Change from baseline in quality of life on the 36-point Short-Form 36(SF-36) at 4 week
Description
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.
Time Frame
Baseline and 4 week
Title
Change from baseline in disability on the 20-point at 4 week Neck Pain and Disability Scale (NPDS) at 4 week
Description
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.
Time Frame
Baseline and 4 week
Title
Change from baseline in range of motion on the universal goniometer at 4 week
Description
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.
Time Frame
Baseline and 4 week
Title
Change from baseline in number of trigger points on the manual palpation at 4 week
Description
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.
Time Frame
Baseline and 4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer BİNGÖLBALİ, Master
Organizational Affiliation
Mus Alparslan Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mus Alparslan University
City
Muş
State/Province
Güzeltepe District
ZIP/Postal Code
49100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28845185
Citation
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.
Results Reference
background
PubMed Identifier
18315516
Citation
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.
Results Reference
background
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Deep Tissue Massage in the Myofascial Pain Syndrome
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