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

NCT ID: NCT05297656

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2023-10-15

Brief Summary

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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

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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

Conditions

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Myofascial Pain Instrument Assisted Soft Tissue Mobilization

Keywords

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miyofascial pain Instrument Assisted Soft Tissue Mobilization Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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

Group Type EXPERIMENTAL

Instrument Assisted Soft Tissue Mobilization

Intervention Type OTHER

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

Home exercises programe

Intervention Type OTHER

Only Home exercises programe

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.

Group Type SHAM_COMPARATOR

Sham Instrument Assisted Soft Tissue Mobilization

Intervention Type OTHER

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

Intervention Type OTHER

Only Home exercises programe

Control group

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

Group Type OTHER

Home exercises programe

Intervention Type OTHER

Only Home exercises programe

Interventions

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Instrument Assisted Soft Tissue Mobilization

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

Intervention Type 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

Intervention Type OTHER

Home exercises programe

Only Home exercises programe

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Basak Cigdem Karacay

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basak Cigdem Karacay, Asst Prof

Role: STUDY_DIRECTOR

university

Locations

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Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Local ethics

Identifier Type: OTHER

Identifier Source: secondary_id

E-77504701-604.02.-00000386201

Identifier Type: -

Identifier Source: org_study_id