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Completed

NCT Number: NCT05297656

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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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Treatment and study plan

Instrument assisted soft tissue mobilization

Other

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

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

Home exercises programe

Other

Only Home exercises programe

Primary outcomes

  1. Pain Algometer

    Time frame: Baseline

    The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data

  2. Pain Algometer

    Time frame: Fourth week (Posttreatment)

    The pain threshold level will be measured with an algometer. The algometer manually evaluates the patient's pain threshold and gives a numerical data

  3. Visual Analogue Scale (VAS)

    Time frame: Baseline

    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.

  4. Visual Analogue Scale (VAS)

    Time frame: Fourth week (Posttreatment)

    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.

  5. Number and location of trigger points

    Time frame: Baseline

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

  6. Number and location of trigger points

    Time frame: Fourth week (Posttreatment)

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

Secondary outcomes

  1. Beck depression questionnaire

    Time frame: Baseline

    Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).

  2. Beck depression questionnaire

    Time frame: Fourth week (Posttreatment)

    Beck depression questionnaire is a questionnaire consisting of 21 questions that evaluates the mood of the patient and has Turkish validity and reliability(1).

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

    Time frame: Baseline

    The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)

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

    Time frame: Fourth week (Posttreatment)

    The World Health Organization health-related quality of life-brief form (WHO-health-related quality of life-brief form)

  5. The neck disability index

    Time frame: Baseline

    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.

  6. The neck disability index

    Time frame: Fourth week (Posttreatment)

    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.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2022
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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