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)

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

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).

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Other: Conservative Treatment (CT); Other: Instrument-assisted Soft Tissue Mobilization (IASTM); Other: Extracorporeal Shock Wave Therapy (ESWT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conservative Treatment (CT); 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); Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.
Experimental: Instrument Assisted Soft Tissue Mobilization (IASTM); 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); 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.
Experimental: Extracorporeal Shock Wave Therapy (ESWT); 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); 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Ankara University
• Collaborators: Gazi University
• Investigators: Principal Investigator: Seyda CANDENIZ, PhD, Ankara University; Study Director: Zafer GUNENDI, Prof.Dr., Gazi University; Study Director: Seyit CITAKER, Prof.Dr., Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pain; IASTM; ESWT; Myofascial Pain Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: candeniz-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No