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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04320108
Other study ID # ESWTbraindamage
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2020
Est. completion date February 5, 2021

Study information

Verified date November 2020
Source Bundang CHA Hospital
Contact MinYoung Kim, MD, PhD
Phone 82-30-780-6281
Email kmin@cha.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date February 5, 2021
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Device:
Extracorporeal shockwave therapy
Extracorporeal shockwave therapy 6 times during 2 weeks

Locations

Country Name City State
Korea, Republic of Department of Rehabilitation Medicine, CHA Bundang Medical Center Seongnam

Sponsors (1)

Lead Sponsor Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical rating scale (NRS) Pain intensity (0-10, ordinal scale) Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary Shoulder Pain and Disability Index (SPADI) Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst) Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)
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