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

NCT05297656 | Completed

• 2 other identifiers: E-77504701-604.02.-00000386201Local ethics
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myofascial Pain; Instrument Assisted Soft Tissue Mobilization

Keywords

miyofascial pain; Instrument Assisted Soft Tissue Mobilization; Quality of life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Beck depression questionnaire

  Baseline

• Beck depression questionnaire

  Fourth week (Posttreatment)

• The World Health Organization health-related quality of life-brief form

  Baseline

• The World Health Organization health-related quality of life-brief form

  Fourth week (Posttreatment)

• The neck disability index

  Baseline

Study Arms (3)

Experimental Group

EXPERIMENTAL

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; Other: Home exercises programe

Sham Comparator Group

SHAM COMPARATOR

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: Sham Instrument Assisted Soft Tissue Mobilization; Other: Home exercises programe

Control group

OTHER

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

Interventions

Instrument Assisted Soft Tissue Mobilization OTHER

Instrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe

Experimental Group

Sham Instrument Assisted Soft Tissue Mobilization OTHER

Instrument Assisted Soft Tissue Mobilization to be applied superficially so it is not like a real graston tecnique and Home exercises programe

Sham Comparator Group

Home exercises programe OTHER

Only Home exercises programe

Control group; Experimental Group; Sham Comparator Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Since the anatomical muscle structure and physiology of men and women are different, we only made it in women in order to eliminate this difference.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

Location

Study Officials

• Basak Cigdem Karacay, Asst Prof

  university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study was designed as blinded, randomized and controlled. The person who evaluates the patients before and after the treatment is blind. In other words, the person evaluating the patients and the person giving the treatment are different.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: April 8, 2022
• Primary Completion: September 15, 2023
• Study Completion: October 15, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)