Clinical trial NCT05699798: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: IASTM
ESWT
Myofascial Pain Syndrome
Pain
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2023-01-26
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: Third week (Posttreatment)
measure: Pressure Pain Threshold
timeFrame: Baseline
measure: Pressure Pain Threshold
timeFrame: Third week (Posttreatment)
measure: Cervical Joint Range of Motion
timeFrame: Baseline
measure: Cervical Joint Range of Motion
timeFrame: Third week (Posttreatment)
Secondary outcomes:
measure: Disability
timeFrame: Baseline
measure: Disability
timeFrame: Third week (Posttreatment)
measure: Depression and Anxiety
timeFrame: Baseline
measure: Depression and Anxiety
timeFrame: Third week (Posttreatment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Seyda CANDENIZ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Zafer GUNENDI, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Seyit CITAKER, Prof.Dr.
role: STUDY_DIRECTOR
References: