ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

Detailed Description
-----------------
6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/m^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy

Official Title
-----------------
The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury

Conditions
-----------------
Spastic Tetraplegia, Pain, Myelopathy Cervical

Intervention / Treatment
-----------------
* Device: Extracorporeal shockwave therapy
* Device: Sham therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal cord damage confirmed in the spinal cord image 1 month after spinal cord injury Spasticity of upper extremities Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS) Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE) Age: 20 and older Person who has agreed in writing to decide his or her participation and comply with the precautions Exclusion Criteria: Pain due to trauma Injection treatments two weeks before participating in the study Severe coagulopathy (excluding antiplatelet use) Impaired cognition

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Experimental group<br>3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range | Device: Extracorporeal shockwave therapy<br>* 6 times during 2 weeks<br>|
| Sham Comparator: Control group<br>Sham therapy | Device: Sham therapy<br>* 6 times during 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | Pain intensity (0-10, ordinal scale) | Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth scale (MAS) | Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity) | Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks) | 
| Range of motion (ROM) | Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range) | Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks) | 
| Grasp power | Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power) | Up to 4 weeks (baseline, 2 weeks, 4 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal shockwave therapy, Cervical myelopathy, Spasticity, Pain