Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome

March 23, 2021 updated by: Fatma Uguz Selcuk, Pamukkale University

Effectiveness of Radial Shock-wave Therapy Combined With Self-stretching Exercises in Patients With Myofascial Pain Syndrome

30 patients with chronic cervical myofascial pain (4 males, 26 females) aged between 25 to 57 years (with average age 41,20±10,23 years) were included the study.

Participants were divided into two groups as intervention group (n=15) and control group (n=15). Patients in intervention group received radial shock-wave application one times a week for six weeks and home based stretching exercises. Patients in control group (CG) received home based stretching exercises. Rest and activity pain (Visual Analog Scale), pressure pain threshold (PPT), cervical range of motion (CROM) and disability (Neck Disability Index) were assessed at baseline and after the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty-four cervical MPS patients aged between 25-57 years (average age: 41,20±10,23 years) who diagnosed cervical MPS (myofascial pain syndrome), had cervical MPS for 6 months and who had at least one trigger point on their cervical, back and shoulder muscles were included to this study.

Thirty-four participant were included to the study. Taking into consideration including and excluding factors 34 participants divided into two groups: intervention shock-wave therapy group, control group. Because of several private reason (not attending treatment regularly and not participating in the final evaluations), 4 participant were excluded from study.

All assessments done by the same physiotherapist (FU) before the first session and one week after the last treatment session. Demographic data of participants recorded by using a form at the baseline of the study.

Patients in the intervention group (n=15) received 6 sessions radial shock wave treatment once a week during 6 weeks. During the treatment, the patients sat on chairs and supported their upper bodies with a pillow on the bed. Ultrasound gel was applied to the application area. Radial shock-wave therapy was applied to each trigger point in the preliminary evaluation. The muscles related trigger points were stretched position during the application. Radial shock-wave therapy was applied in 1.0-4.0 bar intensity, 10-15 hz frequency interval. 300-700 pulse for a trigger point, 1500-3000 pulse for a muscle. Intensity, frequency and pulse increased every session regularly beginning from minimal taking patients tolerance into consideration. Trigger points in the upper, middle and lower trapezius, supraspinatus, infraspinatus and levator scapulae muscles were treated.

Neck and upper back muscle static stretching exercises were teached to patients in the both groups as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Silivri
      • Istanbul, Silivri, Turkey, 34000
        • Silivri Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed cervical MPS
  • Have cervical MPS for at least 6 months.
  • Patients who has at least one trigger points on their cervical, back and shoulder muscles.

Exclusion Criteria:

  • Fibromyalgia diagnosed patients in reference to 1990 ACR criteria.
  • Patients who has characteristic cervical disc degeneration, radiculopathy, myelopathy.
  • Patients who has cervical fracture, tumor, infection, malign, psychiatric and systemic illness.
  • Patients who had an operation because of cervical problem.
  • Patients who is treated with another treatment technique at the same time.
  • Being pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radial shock-wave group
Group I (15 subjects) received radial shock-wave application one times a week for six weeks and home based stretching exercises.
Procedure: Radial Shock-Wave Therapy
Radial shock-wave therapy was applied in 1.0-4.0 bar intensity, 10-15 hz frequency interval. 300-700 pulse for a trigger point, 1500-3000 pulse for a muscle. Intensity, frequency and pulse increased every session regularly beginning from minimal taking patients tolerance into consideration. Trigger points in the upper, middle and lower trapezius, supraspinatus, infraspinatus and levator scapula muscles were treated. Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.
Experimental: Control
Group II (15 subjects) received home based stretching exercises for six weeks.
Procedure: Control
Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline
Pain intensity was measured using a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain).
Baseline
Cervical Range of Motion
Time Frame: Baseline
Cervical range of motion (CROM) tool was used to assess cervical range of motion. Measurements were repeated three times in flexion, extension, rotation and lateral flexion directions.
Baseline
Disability
Time Frame: Baseline
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Baseline
Pressure pain threshold (PPT)
Time Frame: Baseline
Digital pressure algometer applied to patients active trigger points.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 6 weeks
Pain intensity was measured using a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain).
6 weeks
Cervical Range of Motion
Time Frame: 6 weeks
Cervical range of motion (CROM) tool was used to assess cervical range of motion. Measurements were repeated three times in flexion, extension, rotation and lateral flexion directions.
6 weeks
Disability
Time Frame: 6 weeks
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
6 weeks
Pressure pain threshold (PPT)
Time Frame: 6 weeks
Digital pressure algometer applied to patients active trigger points.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Chair: Aysenur OYMAK SOYSAL, Dr., Sarayköy Vocational School
  • Study Chair: Erol Ozen, Dr., Denizli Private Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2013

Primary Completion (Actual)

April 10, 2013

Study Completion (Actual)

June 30, 2013

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24.01.2013/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Because there is no web site to share my data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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