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ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

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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

Tracking Information
First Submitted Date  ICMJE March 14, 2020
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date May 5, 2020
Estimated Study Start Date  ICMJE May 11, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2020)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ESWT for UE Pain in Patients With Cervical Spinal Cord Injury
Official Title  ICMJE The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spastic Tetraplegia
  • Pain
  • Myelopathy Cervical
Intervention  ICMJE
  • Device: Extracorporeal shockwave therapy
    6 times during 2 weeks
  • Device: Sham therapy
    6 times during 2 weeks
Study Arms  ICMJE
  • Experimental: Experimental group
    3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
    Intervention: Device: Extracorporeal shockwave therapy
  • Sham Comparator: Control group
    Sham therapy
    Intervention: Device: Sham therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 5, 2021
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyunghoon Min, MD, PhD 82-30-780-1892 minkhrm@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04319679
Other Study ID Numbers  ICMJE ESWTSCIPain
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Information that cannot be identified
Supporting Materials: Study Protocol
Responsible Party MinYoung Kim, MD, PhD, Bundang CHA Hospital
Study Sponsor  ICMJE Bundang CHA Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyunghoon Min, MD, PhD Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
PRS Account Bundang CHA Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP