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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)

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conservative Treatment (CT)
Instrument-assisted Soft Tissue Mobilization (IASTM)
Extracorporeal Shock Wave Therapy (ESWT)
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring IASTM, ESWT, Myofascial Pain Syndrome, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conservative Treatment (CT)

Instrument Assisted Soft Tissue Mobilization (IASTM)

Extracorporeal Shock Wave Therapy (ESWT)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Pressure Pain Threshold
Pressure Pain Threshold was measured with an algometer. The algometer evaluates the patient's pain threshold and gives a numerical data.
Pressure Pain Threshold
Pressure Pain Threshold was measured with an algometer. The algometer evaluates the patient's pain threshold and gives a numerical data.
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.
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.

Secondary Outcome Measures

Disability
Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS).
Disability
Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS).
Depression and Anxiety
Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).
Depression and Anxiety
Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).

Full Information

First Posted
January 17, 2023
Last Updated
January 26, 2023
Sponsor
Ankara University
Collaborators
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05699798
Brief Title
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)
Official Title
Comparison of the Efficacy of Instrument-assisted Soft Tissue Mobilization and Extracorporeal Shock Wave Therapy in Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
Collaborators
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
IASTM, ESWT, Myofascial Pain Syndrome, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Treatment (CT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Instrument Assisted Soft Tissue Mobilization (IASTM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Extracorporeal Shock Wave Therapy (ESWT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative Treatment (CT)
Intervention Description
Conservative treatment (HP, US, TENS) was applied for 3 weeks, with 5 sessions per week, a total of 15 sessions.
Intervention Type
Other
Intervention Name(s)
Instrument-assisted Soft Tissue Mobilization (IASTM)
Intervention Description
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
Intervention Name(s)
Extracorporeal Shock Wave Therapy (ESWT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
Baseline
Title
Pain Intensity
Description
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.
Time Frame
Third week (Posttreatment)
Title
Pressure Pain Threshold
Description
Pressure Pain Threshold was measured with an algometer. The algometer evaluates the patient's pain threshold and gives a numerical data.
Time Frame
Baseline
Title
Pressure Pain Threshold
Description
Pressure Pain Threshold was measured with an algometer. The algometer evaluates the patient's pain threshold and gives a numerical data.
Time Frame
Third week (Posttreatment)
Title
Cervical Joint Range of Motion
Description
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.
Time Frame
Baseline
Title
Cervical Joint Range of Motion
Description
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.
Time Frame
Third week (Posttreatment)
Secondary Outcome Measure Information:
Title
Disability
Description
Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS).
Time Frame
Baseline
Title
Disability
Description
Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS).
Time Frame
Third week (Posttreatment)
Title
Depression and Anxiety
Description
Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).
Time Frame
Baseline
Title
Depression and Anxiety
Description
Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).
Time Frame
Third week (Posttreatment)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Since the anatomical muscle structure and physiology of men and women are different, we only made it in women in order to eliminate this difference.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda CANDENIZ, PhD
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zafer GUNENDI, Prof.Dr.
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seyit CITAKER, Prof.Dr.
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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