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

Bundang CHA Hospital1 site in 1 country4 target enrollmentJune 5, 2020

ConditionsSpastic Tetraplegia Pain Myelopathy Cervical

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spastic Tetraplegia
Sponsor: Bundang CHA Hospital
Enrollment: 4
Locations: 1
Primary Endpoint: Numerical rating scale (NRS)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

June 5, 2020

End Date

April 13, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bundang CHA Hospital

Responsible Party

Principal Investigator

MinYoung Kim, MD, PhD

Principal Professor of Rehabilitation Medicine

Bundang CHA Hospital

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

Outcomes

Primary Outcomes

Numerical rating scale (NRS)

Time Frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

Pain intensity (0-10, ordinal scale)

Secondary Outcomes

Grasp power(Up to 4 weeks (baseline, 2 weeks, 4 weeks))
Modified Ashworth scale (MAS)(Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks))
Range of motion (ROM)(Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks))