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

Primary Purpose

Myofascial Pain, Instrument Assisted Soft Tissue Mobilization

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization
Sham Instrument Assisted Soft Tissue Mobilization
Home exercises programe
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain focused on measuring miyofascial pain, Instrument Assisted Soft Tissue Mobilization, Quality of life

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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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Sites / Locations

  • Kırşehir Ahi Evran University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Experimental Group

Sham Comparator Group

Control group

Arm Description

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

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.

The volunteers in the control group will be only given home exercise therapy including stretching of the trapezius muscle and posture exercises

Outcomes

Primary Outcome Measures

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
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
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.
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.
Number and location of trigger points
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
Number and location of trigger points
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.

Secondary Outcome Measures

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).
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).
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)
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)
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.
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.

Full Information

First Posted
March 17, 2022
Last Updated
August 1, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05297656
Brief Title
The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Instrument Assisted Soft Tissue Mobilization
Keywords
miyofascial pain, Instrument Assisted Soft Tissue Mobilization, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Comparator Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
The volunteers in the control group will be only given home exercise therapy including stretching of the trapezius muscle and posture exercises
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization
Intervention Description
Instrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe
Intervention Type
Other
Intervention Name(s)
Sham Instrument Assisted Soft Tissue Mobilization
Intervention Description
Instrument Assisted Soft Tissue Mobilization to be applied superficially so it is not like a real graston tecnique and Home exercises programe
Intervention Type
Other
Intervention Name(s)
Home exercises programe
Intervention Description
Only Home exercises programe
Primary Outcome Measure Information:
Title
Pain Algometer
Description
The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data
Time Frame
Baseline
Title
Pain Algometer
Description
The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data
Time Frame
Fourth week (Posttreatment)
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Fourth week (Posttreatment)
Title
Number and location of trigger points
Description
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
Time Frame
Baseline
Title
Number and location of trigger points
Description
The number and location of trigger points that cause myofascial pain will be determined and recorded by examination.
Time Frame
Fourth week (Posttreatment)
Secondary Outcome Measure Information:
Title
Beck depression questionnaire
Description
Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).
Time Frame
Baseline
Title
Beck depression questionnaire
Description
Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).
Time Frame
Fourth week (Posttreatment)
Title
The World Health Organization health-related quality of life-brief form
Description
The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)
Time Frame
Baseline
Title
The World Health Organization health-related quality of life-brief form
Description
The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)
Time Frame
Fourth week (Posttreatment)
Title
The neck disability index
Description
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.
Time Frame
Baseline
Title
The neck disability index
Description
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.
Time Frame
Fourth week (Posttreatment)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basak Cigdem Karacay, Asst Prof
Phone
+905445094803
Email
basak.cigdemkaracay@ahievran.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Asst Prof
Organizational Affiliation
university
Official's Role
Study Director
Facility Information:
Facility Name
Kırşehir Ahi Evran University Faculty of Medicine
City
Kırşehir
State/Province
City Center
ZIP/Postal Code
40100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Asist Prof
Phone
0905445094803
Email
basak.cigdemkaracay@ahievran.edu.tr
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Asist Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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

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