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)

NCT05699798 | Completed

• 1 other identifier: candeniz-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Myofascial Pain Syndrome

Keywords

IASTM; ESWT; Myofascial Pain Syndrome; Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Disability

  Baseline

• Disability

  Third week (Posttreatment)

• Depression and Anxiety

  Baseline

• Depression and Anxiety

  Third week (Posttreatment)

Study Arms (3)

Conservative Treatment (CT)

EXPERIMENTAL

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)

Instrument Assisted Soft Tissue Mobilization (IASTM)

EXPERIMENTAL

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)

Extracorporeal Shock Wave Therapy (ESWT)

EXPERIMENTAL

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)

Interventions

Conservative Treatment (CT) OTHER

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

Conservative Treatment (CT)

Instrument-assisted Soft Tissue Mobilization (IASTM) 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.

Instrument Assisted Soft Tissue Mobilization (IASTM)

Extracorporeal Shock Wave Therapy (ESWT) 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.

Extracorporeal Shock Wave Therapy (ESWT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious cervical disc disorders
• Tumor
• Fibromyalgia
• Mental or psychotic disorders
• Venous insufficiency
• Active infection
• Pregnancy
• Allergic skin diseases
• Acute rheumatic diseases

Sponsors & Collaborators

• Ankara University: lead
• Gazi University: collaborator

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Pain

Interventions

Conservative Treatment; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Physical Therapy Modalities; Rehabilitation

Study Officials

• Seyda CANDENIZ, PhD

  Ankara University

  PRINCIPAL INVESTIGATOR

• Zafer GUNENDI, Prof.Dr.

  Gazi University

  STUDY DIRECTOR

• Seyit CITAKER, Prof.Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: June 27, 2022
• Primary Completion: July 18, 2022
• Study Completion: October 14, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)