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Clinical Trials/NCT04320108
NCT04320108CompletedNot Applicable

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

Bundang CHA Hospital2 sites in 2 countries6 target enrollmentStarted: May 29, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
2
Primary Endpoint
Numerical rating scale (NRS)

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MinYoung Kim, MD, PhD

Principal professor of Rehabilitation Medicine

Bundang CHA Hospital

Study Sites (2)

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