Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319679
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, MD, PhD, Bundang CHA Hospital

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.

Condition or disease Intervention/treatment Phase
Spastic Tetraplegia Pain Myelopathy Cervical Device: Extracorporeal shockwave therapy Device: Sham therapy Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
Estimated Study Start Date : May 11, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : February 5, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319679


Contacts
Layout table for location contacts
Contact: Kyunghoon Min, MD, PhD 82-30-780-1892 minkhrm@gmail.com

Locations
Layout table for location information
Korea, Republic of
Department of Rehabilitation Medicine, CHA Bundang Medical Center, Recruiting
Seongnam, Korea, Republic of, 13496
Contact: Kyunghoon Min, MD, PhD       minkhrm@gmail.com   
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kyunghoon Min, MD, PhD Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
Layout table for additonal information
Responsible Party: MinYoung Kim, MD, PhD, Principal Professor of Rehabilitation Medicine, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT04319679    
Other Study ID Numbers: ESWTSCIPain
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information that cannot be identified
Supporting Materials: Study Protocol

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MinYoung Kim, MD, PhD, Bundang CHA Hospital:
Extracorporeal shockwave therapy
Cervical myelopathy
Spasticity
Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Spinal Cord Diseases
Quadriplegia
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms
Hematologic Diseases
Paralysis