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)

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05699798
• Other study ID #: candeniz-001
• Status: Completed
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: October 14, 2022

Study information

• Verified date: January 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 14, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Conservative Treatment (CT)
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)
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)
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.

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Ankara University	Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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	Disability	Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS).	Baseline
Secondary	Disability	Disability, Cervical Mobility, Sleep and Quality of Life parameters were evaluated with the Neck Outcome Score Questionnaire (NOOS).	Third week (Posttreatment)
Secondary	Depression and Anxiety	Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).	Baseline
Secondary	Depression and Anxiety	Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).	Third week (Posttreatment)