Effect of Radial Extracorpeal Shock Wave on Pain and Function

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study will be focused on the following issues. Evaluation of the effect of radial extracorporeal shock wave on the pressure pain threshold and disability in stroke hemiplegic shoulder.

Detailed Description
-----------------
Further understanding of rotator cuff tendon impairment and other shoulder soft tissue structural abnormalities in stroke patients may help clinicians in assigning more complete therapeutic plans to hemiplegic patients. The radial extra-corporeal shock-wave therapy has promising results in patients with musculoskeletal problems and in those with various causes of HSP, including spasticity, rotator cuff problems, adhesive capsulitis, and complex regional pain syndrome.

Official Title
-----------------
Effect of Radial Extracorpeal Shock Wave on Pain and Function in Hemplegic Shoulder Pain Patients

Conditions
-----------------
Hemiplegia

Intervention / Treatment
-----------------
* Device: radial extracorpeal shock wave


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's age ranges from 40 to 60 years. Spasticity of upper limb ranges from mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS). Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24). Patient who understand the study process and signed the informed consent form. Patient with stroke more than 3 months ago. 8. Patient with shoulder pain and limited range of motion (ROM) or loss of motion in the proximal arm on the hemiplegic side. Exclusion Criteria: 1. Patients who cannot express their own pain intensity. 2. Patients with a history of trauma or surgery to the shoulder on the affected side. 3. Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.0. 4. Patients with a history of shoulder pain before the stroke. 6. Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT. 7. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients with psychological problems.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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
Interventional Model Description: The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII). The study group (GI) will be treated by the radial extracorporeal shock wave in addition to design physical therapy program. The control group (GII) will be treated by sham radial extracorporeal shock wave in addition to the same design physical therapy program of (GI).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>Patients will received 3,000 pulses, 1,500 pulses per site at a frequency of 12 Hz per session with the submaximal pressure between 0.39 and 1.95 mJ/mm2 (1.0 and 5.0 bar), depending on the level which the patient can tolerate without local anesthetics. | Device: radial extracorpeal shock wave<br>* Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor<br>|
| Sham Comparator: control group<br>The patients in this group will be treated by sham radial extracorporeal shock wave therapy | Device: radial extracorpeal shock wave<br>* Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain pressure threshold (PPT) assessment by using pressure algometer procedures | Pain pressure threshold measurement will be obtained in the same order for all patients.The pressure will be applied with 0.785 cm2 rubber tip at a rate of 1 kg/cm2/sec 27 at the site of measurement. The measurement will at the mid-belly of the deltoid of the painful shoulder. The tip of the algometer will be positioned on this specific point. By pushing the algometer, the force will be applied to the mid belly of deltoid gradually increased. The patients will not allowed to see the algometer display in any moment, and, as soon as the volunteers experience a painful sensation, they say stop, the algometer will immediately release and the force (in Kpa) will be read from the display. Pain pressure threshold will be measured three times per patient on each site and the average will be calculated and will be used for analysis. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder range of motion assessment by using magnetic inclinometer | Total shoulder flexion will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion. Total shoulder abduction will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ROM, pain thrshold