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Completed

NCT Number: 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)

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).

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative treatment (CT)

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)

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)

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.

Primary outcomes

  1. Pain Intensity

    Time frame: Baseline

    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.

  2. Pain Intensity

    Time frame: Third week (Posttreatment)

    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.

  3. Pressure Pain Threshold

    Time frame: Baseline

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

  4. Pressure Pain Threshold

    Time frame: Third week (Posttreatment)

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

  5. Cervical Joint Range of Motion

    Time frame: Baseline

    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.

  6. Cervical Joint Range of Motion

    Time frame: Third week (Posttreatment)

    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 outcomes

  1. Disability

    Time frame: Baseline

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

  2. Disability

    Time frame: Third week (Posttreatment)

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

  3. Depression and Anxiety

    Time frame: Baseline

    Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).

  4. Depression and Anxiety

    Time frame: Third week (Posttreatment)

    Depression and Anxiety parameters were evaluated with the Hospital Anxiety and Depression Scale (HADS).

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Gazi University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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