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

Myofascial Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297656
• Other study ID #: E-77504701-604.02.-00000386201
• Secondary ID: Local ethics
• Status: Completed
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: December 2023
• Source: Kirsehir Ahi Evran Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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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Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain
• Myofascial Pain Syndromes

Intervention

Other:
• Instrument Assisted Soft Tissue Mobilization
Instrument Assisted Soft Tissue Mobilization with graston tecnique and Home exercises programe
• 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
• Home exercises programe
Only Home exercises programe

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University Faculty of Medicine	Kirsehir	City Center

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

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