The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome

The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome Due to Active Trigger Points in the Upper Trapezius Muscles

The primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue mobilization on pain, functionality, quality of life and depression in the treatment of female patients with myofascial pain syndrome due to active trigger points in the upper trapezius muscles

Study Overview

• Status: Completed
• Conditions: Myofascial Pain; Instrument Assisted Soft Tissue Mobilization
• Intervention / Treatment: Other: Instrument Assisted Soft Tissue Mobilization; Other: Home exercises programe; Other: Sham Instrument Assisted Soft Tissue Mobilization

Detailed Description

Myofascial Pain Syndrome (MAS); It is a non-articular, non-inflammatory regional musculoskeletal pain syndrome characterized by myofascial trigger points located at muscle, fascia or tendon insertion sites and the spread of pain to reference areas by palpation of these points.

h The effectiveness of massage therapy in MAS is known. In this study, investigators will apply instrument assisted deep tissue mobilization (graston massage). Instrument-assisted soft tissue mobilization massage, which is a type of massage, will be applied by a physiotherapist who has a certificate on this subject and takes part as an assistant researcher in our study.

Soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises already prescribed for patients with musculoskeletal injuries.

The various sizes and beveled edges of the stainless steel instruments allow physiotherapists to tailor treatment to different muscle structures facing myofascial constraints.

Localized increases in blood flow and soft tissue realignment lead to muscle function, increased normal joint motion, and decreased pain.

It has been investigated in the literature for many different diseases (trigger finger, nonspecific low back pain, myofascial pain syndrome) and found to be effective.CF

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • City Center
    • Kırşehir, City Center, Turkey, 40100
      • Kırşehir Ahi Evran University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Being woman and between the ages of 18-45
2. Not to be in menopause
3. Pain in the upper trapezius area
4. Detection of a taut band in the upper trapezius region on examination
5. At least one active trigger point in the tension band in the upper trapezius region on examination
6. The pain caused by the compression of the trigger point is the pain that the patient complains about
7. Painful restriction of cervical lateral flexion motion during stretching
8. Pain 4 or more according to NRS

Exclusion Criteria:

1. major surgery or trauma to the musculoskeletal system, especially the spine and upper extremities 2.History of any operation related to the head and neck region 3. Neuromuscular disease 4. History of rheumatic disease, malgnite in the active period 4. Cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia 5. Psychiatric disease (Beck Depression Inventory score of 30 and above) 6.Obese (BMI≥30 kg/m2)

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; A total of 8 sessions of graston massage protocol will be applied to the patients in the experimental group for 4 weeks, 2 days a week for 5 minutes, at the hospital operating within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. All patients will also receive home exercise therapy including stretching of the trapezius muscle and posture exercises	Other: Instrument Assisted Soft Tissue Mobilization; Instrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe; Other: Home exercises programe; Only Home exercises programe
Sham Comparator: Sham Comparator Group; A total of 8 sessions of sham graston massage protocol will be applied to the patients in the experimental group for 4 weeks, 2 days a week for 5 minutes, at the hospital operating within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Sham graston massage is not a deep tissue massage, but will be performed with the device superficially, without applying pressure and mobilization. All patients will also receive home exercises.	Other: Home exercises programe; Only Home exercises programe; Other: Sham Instrument Assisted Soft Tissue Mobilization; Instrument Assisted Soft Tissue Mobilization to be applied superficially so it is not like a real graston tecnique and Home exercises programe
Other: Control group; The volunteers in the control group will be only given home exercise therapy including stretching of the trapezius muscle and posture exercises	Other: Home exercises programe; Only Home exercises programe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Algometer	The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data	Baseline
Pain Algometer	The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data	Fourth week (Posttreatment)
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) for pain assessment. In this scale, which evaluates pain with a 10-point Likert scale, 0 is scored as no pain, 5 as moderate pain, and 10 as excruciating pain.	Baseline
Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) for pain assessment. In this scale, which evaluates pain with a 10-point Likert scale, 0 is scored as no pain, 5 as moderate pain, and 10 as excruciating pain.	Fourth week (Posttreatment)
Number and location of trigger points	The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.	Baseline
Number and location of trigger points	The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.	Fourth week (Posttreatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck depression questionnaire	Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).	Baseline
Beck depression questionnaire	Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).	Fourth week (Posttreatment)
The World Health Organization health-related quality of life-brief form	The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)	Baseline
The World Health Organization health-related quality of life-brief form	The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)	Fourth week (Posttreatment)
The neck disability index	The neck disability index is a questionnaire consisting of 10 questions with Turkish validity and reliability, which recognizes the functional evaluation of neck pain (3). Each question is scored between 0 and 5. High scores are associated with increased disability.	Baseline
The neck disability index	The neck disability index is a questionnaire consisting of 10 questions with Turkish validity and reliability, which recognizes the functional evaluation of neck pain (3). Each question is scored between 0 and 5. High scores are associated with increased disability.	Fourth week (Posttreatment)

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Study Director: Basak Cigdem Karacay, Asst Prof, University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; miyofascial pain; Instrument Assisted Soft Tissue Mobilization
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: E-77504701-604.02.-00000386201; Local ethics (Other Identifier: 2022-03/21)

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
• product manufactured in and exported from the U.S.: No