ESWT for Shoulder Pain in Patients With Brain Damage

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320108
• Other study ID #: ESWTbraindamage
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Damage, Hypoxic
• Brain Injuries
• Brain Tumor
• Hypoxia, Brain
• ICH
• Shoulder Pain
• Stroke

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)