ESWT for Shoulder Pain in Patients With Brain Damage

Not Applicable

• Conditions: Stroke; Brain Tumor; Brain Damage, Hypoxic; ICH
• Interventions: Device: Extracorporeal shockwave therapy

• Registration Number: NCT04320108
• Lead Sponsor: Bundang CHA Hospital

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 Timeline

• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Study Start: 2020-05-29
• Primary Completion: 2020-10-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Study Completion: 2021-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Extracorporeal shockwave therapy	Sham therapy
Experimental group	Extracorporeal shockwave therapy	3,000 pulses per time, low energy under 0.3 mJ/mm\^2, tolerable range

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)	Pain intensity (0-10, ordinal scale)

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)	Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst)

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center; 🇰🇷 Seongnam, Korea, Republic of