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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Myofascial Pain Syndrome, Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Radial Shock-Wave Therapy
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radial shock-wave group<br>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<br>* 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.<br>|
| Experimental: Control<br>Group II (15 subjects) received home based stretching exercises for six weeks. | Procedure: Control<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | 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 | 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 | Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. | Baseline | 
| Pressure pain threshold (PPT) | Digital pressure algometer applied to patients active trigger points. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | 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 | 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 | Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. | 6 weeks | 
| Pressure pain threshold (PPT) | Digital pressure algometer applied to patients active trigger points. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy, shock wave therapy, stretching exercises