Massage TherapyNCT04904367
Deep Tissue Massage in the Myofascial Pain Syndrome
A study testing Deep tissue massage and Conventional physiotherapy in people with Massage Therapy and Myofascial Pain Syndrome, run by Ömer Bingölbali at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Massage Therapy, Myofascial Pain Syndrome
- What is being tested?
- Deep tissue massage and Conventional physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 22 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mus Alparslan University
Muş, Güzeltepe District, 49100
About this study
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
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).
Read the 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).
- Conditions
- Massage Therapy, Myofascial Pain Syndrome
- Being tested
- Deep tissue massage, Conventional physiotherapy
- Keywords
- Myofascial pain syndrome, Neck disability, Pain, Quality of life
- Medical subject headings
- Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep tissue massageProcedure or surgery
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.
Conventional physiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep tissue massage | Active comparator | 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. Receives: Procedure: Deep tissue massage; Procedure: Conventional physiotherapy |
| Conventional physiotherapy | Experimental | 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. Receives: Procedure: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 week
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.
Measured: Baseline and 4 week
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.
Measured: Baseline and 4 week
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.
Measured: Baseline and 4 week
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.
Measured: Baseline and 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jan 2019
- Primary completion22 May 2021
- Study completion22 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Massage TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ömer Bingölbali
- Sponsor type
- University, hospital or other
- Collaborators
- Muş Alparslan University
- Responsible party
- Sponsor-investigator, Ömer Bingölbali, Muş Alparslan University
- Investigators
- Ömer BİNGÖLBALİ, Master, Principal investigator, Mus Alparslan Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904367
- Sponsor's protocol ID
- 2018/306
- Status last verified
- Sep 2025
- First submitted
- 21 May 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28845185Kaye 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.
PubMed 18315516
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04904367
- Acronym / sponsor ID
- 2018/306
- Conditions
- Massage Therapy, Myofascial Pain Syndrome
- Keywords
- Myofascial pain syndrome, Neck disability, Pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ömer BingölbaliUniversity, hospital or other
- Collaborators
- Muş Alparslan University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 22 May 2021 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep tissue massage | Active comparator | Procedure: Deep tissue massage, Procedure: Conventional physiotherapyFor 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. |
| Conventional physiotherapy | Experimental | Procedure: Conventional physiotherapyFor 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep tissue massageThe 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. | Procedure or surgery | Deep tissue massage |
| Conventional physiotherapyFor 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. | Procedure or surgery | Conventional physiotherapy, Deep tissue massage |
Primary outcome
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.
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.
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
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
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.
Change from baseline in number of trigger points on the manual palpation at 4 week
Time frame: Baseline and 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 28845185Romanowski 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.
- Background: PubMed 18315516Kaye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ömer BİNGÖLBALİ, Master principal investigator
Mus Alparslan Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep tissue massage and Conventional physiotherapy in people with Massage Therapy and Myofascial Pain Syndrome, run by Ömer Bingölbali at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in neck pain on the 10-point Visual Analog Scale(VAS) at 4 week (time frame: Baseline and 4 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.