- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04319679
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
-
-
-
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:
- 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
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
|
6 times during 2 weeks
|
Sham Comparator: Control group
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
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
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.
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