ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

April 13, 2021 updated by: MinYoung Kim, MD, PhD, Bundang CHA Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

4

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

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 13496
        • Department of Rehabilitation Medicine, CHA Bundang Medical Center,

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Spinal cord damage confirmed in the spinal cord image
  2. 1 month after spinal cord injury
  3. Spasticity of upper extremities
  4. Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
  5. Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
  6. Age: 20 and older
  7. Person who has agreed in writing to decide his or her participation and comply with the precautions

Exclusion Criteria:

  1. Pain due to trauma
  2. Injection treatments two weeks before participating in the study
  3. Severe coagulopathy (excluding antiplatelet use)
  4. Impaired cognition

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: Experimental group
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
Device: Extracorporeal shockwave therapy
6 times during 2 weeks
Sham Comparator: Control group
Sham therapy
Device: Sham therapy
6 times during 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
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)
Time Frame: Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
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
Time Frame: Up to 4 weeks (baseline, 2 weeks, 4 weeks)
Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)
Up to 4 weeks (baseline, 2 weeks, 4 weeks)

Collaborators and Investigators

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

Sponsor

Bundang CHA Hospital

Investigators

  • Principal Investigator: Kyunghoon Min, MD, PhD, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

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)

June 5, 2020

Primary Completion (Actual)

April 5, 2021

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESWTSCIPain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Information that cannot be identified

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Pain

Clinical Trials on Extracorporeal shockwave therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe