The Aim of This Study is to Compare the Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) and Extracorporeal Shock Wave Therapy (ESWT) Used in Myofascial Pain Syndrome (MPS) and to Determine Whether They Are Superior to Conservative Treatment (CT)

Study Overview
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Brief Summary
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The Aim of This Study is to Compare the Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) and Extracorporeal Shock Wave Therapy (ESWT) Used in Myofascial Pain Syndrome (MPS) and to Determine Whether They Are Superior to Conservative Treatment (CT). 42 Female Patients Diagnosed With MPS Were Included in the Study. The Patients Were Randomly Divided Into Three Groups of 14 People Each. CT (Hot Pack, TENS, Ultrasound) Was Applied to the First Group. CT+IASTM Was Applied to the Second Group and CT+ESWT Was Applied to the Third Group. All Groups Received Treatment for 3 Weeks (CT: 5 Sessions Per Week, 15 Sessions in Total, ESWT and IASTM: 2 Sessions Per Week, 6 Sessions in Total). Neck Stretching Exercises Were Given to All Patients as a Home Program. Before and After the Treatment, the Pain Intensity of the Patients Was Determined by Visual Analog Scale (VAS). Pressure Pain Threshold Was Measured With an Algometer. Cervical Joint Range of Motion (CROM) Was Measured With a CROM Device. Pain, Cervical Mobility, Quality of Life, and Sleep Parameters Were Evaluated With the Neck Outcome Score Questionnaire (NOOS). Depression and Anxiety Parameters Were Evaluated With the Hospital Anxiety and Depression Scale (HADS).

Detailed Description
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Ethics Approval: The study started with the approval of the Ethics Committee of Gazi University Faculty of Medicine with the 30.05.2022- 427 protocol number. Randomization:42 female patients included in the study were randomized into 3 groups. Interventions:The first group received a Conservative Treatment (CT) program including Hotpack (HP), Ultrasound (US) and Transcutaneous Electrical Nerve Stimulation (TENS), which is routinely given in physical therapy clinics. The second group was given Instrument-Assisted Soft Tissue Mobilization (IASTM) treatment in addition to the CT we applied in the first group. Extracorporeal Shock Wave Therapy (ESWT) was applied to the third group in addition to the CT we applied in the first group. In addition, a home exercise program consisting of neck stretching exercises was given to all participants. The effects of treatments on pain severity, pressure pain threshold, cervical joint range of motion, neck mobility, sleep, activity-pain, quality of life, anxiety and depression were evaluated before and after treatment.

Official Title
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Comparison of the Efficacy of Instrument-assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Myofascial Pain Syndrome

Conditions
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Myofascial Pain Syndrome

Intervention / Treatment
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* Other: Conservative Treatment (CT)
* Other: Instrument-assisted Soft Tissue Mobilization (IASTM)
* Other: Extracorporeal Shock Wave Therapy (ESWT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over 18 years old To be diagnosed with Myofascial Pain Syndrome (MPS) according to Simons diagnostic criteria (having 5 major and at least one minor criterion) Detection of a trigger point in the trapezius muscle Not receiving any treatment for MPS in the last 1 month Exclusion Criteria: Serious cervical disc disorders Tumor Fibromyalgia Mental or psychotic disorders Venous insufficiency Active infection Pregnancy Allergic skin diseases Acute rheumatic diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conservative Treatment (CT)<br>Includes Hotpack, TENS, Ultrasound and home exercise programs. HP, US and TENS applications were applied for 3 weeks, with a total of 15 sessions, 5 sessions per week. HP application for 20 minutes, ultrasound for 5 minutes and TENS for 20 minutes were applied to the patients. The CT protocol was applied to all three groups in the same way. | Other: Conservative Treatment (CT)<br>* Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.<br>|
| Experimental: Instrument Assisted Soft Tissue Mobilization (IASTM)<br>Includes Hotpack, TENS, Ultrasound, home exercise programs and Instrument-assisted Soft Tissue Mobilization Technique. The IASTM therapy was applied for three weeks, two sessions per week, for a total of 6 sessions. | Other: Instrument-assisted Soft Tissue Mobilization (IASTM)<br>* IASTM was performed only on the neck and upper back muscles on the aching side using the sweep technique on the origo and insertion lines. A total of 6 sessions were applied, two sessions per week for 3 weeks. Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.<br>|
| Experimental: Extracorporeal Shock Wave Therapy (ESWT)<br>Includes Hotpack, TENS, Ultrasound, home exercise programs and Extracorporeal Shock Wave Therapy treatment. The ESWT therapy was applied for three weeks, two sessions per week, for a total of 6 sessions. | Other: Extracorporeal Shock Wave Therapy (ESWT)<br>* ESWT therapy was applied on the muscle with active trigger point, at 1.5-2.0 bar pressure, at 10 Hz frequency, 2000 beats in each session, twice a week, in total 6 sessions. Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | The Pain Intensity of the patients was determined by Visual Analog Scale (VAS).The scale is scored between 0 and 10. 0 means no pain, 10 means very severe pain. | Baseline | 
| Pain Intensity | The Pain Intensity of the patients was determined by Visual Analog Scale (VAS).The scale is scored between 0 and 10. 0 means no pain, 10 means very severe pain. | Third week (Posttreatment) | 
| Pressure Pain Threshold | Pressure Pain Threshold was measured with an algometer. The algometer evaluates the patient's pain threshold and gives a numerical data. | Baseline | 
| Pressure Pain Threshold | Pressure Pain Threshold was measured with an algometer. The algometer evaluates the patient's pain threshold and gives a numerical data. | Third week (Posttreatment) | 
| Cervical Joint Range of Motion | Cervical Joint Range of Motion (ROM) was measured with a CROM Device. The degrees of flexion, extension, right rotation, left rotation, right lateral flexion, and left lateral flexion obtained during active joint movement of the cervical region were measured. | Baseline | 
| Cervical Joint Range of Motion | Cervical Joint Range of Motion (ROM) was measured with a CROM Device. The degrees of flexion, extension, right rotation, left rotation, right lateral flexion, and left lateral flexion obtained during active joint movement of the cervical region were measured. | Third week (Posttreatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS). | Baseline | 
| Disability | Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS). | Third week (Posttreatment) | 
| Depression and Anxiety | Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS). | Baseline | 
| Depression and Anxiety | Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS). | Third week (Posttreatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, IASTM, ESWT, Myofascial Pain Syndrome