NCT04904367

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

May 21, 2021

Last Update Submit

September 23, 2025

Conditions

Keywords

Myofascial pain syndromeNeck disabilityPainQuality of life

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline and 4 week

Study Arms (2)

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.

Procedure: Deep tissue massageProcedure: 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.

Procedure: Conventional physiotherapy

Interventions

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.

Deep tissue massage

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.

Conventional physiotherapyDeep tissue massage

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mus Alparslan University

Muş, Güzeltepe District, 49100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 28845185BACKGROUND
  • 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.

    PMID: 18315516BACKGROUND

MeSH Terms

Conditions

Myofascial Pain SyndromesPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ömer BİNGÖLBALİ, Master

    Mus Alparslan Universtiy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 27, 2021

Study Start

January 1, 2019

Primary Completion

May 22, 2021

Study Completion

May 22, 2021

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations