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Clinical Trials/NCT04320108
NCT04320108
Completed
Not Applicable

The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage

Bundang CHA Hospital1 site in 1 country6 target enrollmentMay 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Damage, Hypoxic
Sponsor
Bundang CHA Hospital
Enrollment
6
Locations
1
Primary Endpoint
Numerical rating scale (NRS)
Status
Completed
Last Updated
10 months ago

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/mm\^2, tolerable range) on subscapularis and lesser and greater tuberlces of humerus to reduce pain in patients with brain damage

Registry
clinicaltrials.gov
Start Date
May 29, 2020
End Date
December 11, 2023
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

MinYoung Kim, MD, PhD

Principal professor of Rehabilitation Medicine

Bundang CHA Hospital

Eligibility Criteria

Inclusion Criteria

  • Brain damaged patient confirmed in the brain image
  • 1 month after brain damage
  • Pain in hemiplegic shoulder areas 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

  • Shoulder Pain and Disability Index (SPADI)(Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks))

Study Sites (1)

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