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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04904367
Other study ID # 2018/306
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date May 22, 2021

Study information

Verified date May 2021
Source Mus Alparlan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 22, 2021
Est. primary completion date May 22, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Intervention

Procedure:
Deep tissue massage
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 physiotherapy
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.

Locations

Country Name City State
Turkey Mus Alparslan University Mus Güzeltepe District

Sponsors (1)

Lead Sponsor Collaborator
Ömer Bingölbali

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Romanowski MW, Špiritovic 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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