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)

NCT ID: NCT05699798

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2022-10-14

Brief Summary

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

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.

Conditions

Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Conservative Treatment (CT)

Intervention Type: OTHER

Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.

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.

Group Type: EXPERIMENTAL

Instrument-assisted Soft Tissue Mobilization (IASTM)

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type: OTHER

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.

Interventions

Conservative Treatment (CT)

Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: collaborator

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

şeyda candeniz

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seyda CANDENIZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Zafer GUNENDI, Prof.Dr.

Role: STUDY_DIRECTOR

Gazi University

Seyit CITAKER, Prof.Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

Ankara University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

candeniz-001

Identifier Type: -

Identifier Source: org_study_id