ESWT for Shoulder Pain in Patients With Brain Damage

• Sponsor: Bundang CHA Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04320108
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.3
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Damage, Hypoxic; Stroke; Brain Tumor; ICH	Device: Extracorporeal shockwave therapy	N/A

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
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage
• Actual Study Start Date: May 29, 2020
• Anticipated Primary Completion Date: Oct 31, 2020
• Anticipated Study Completion Date: Feb 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range	Device: Extracorporeal shockwave therapy; Extracorporeal shockwave therapy 6 times during 2 weeks
Sham Comparator: Control group Sham therapy	Device: Extracorporeal shockwave therapy; Extracorporeal shockwave therapy 6 times during 2 weeks

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Rehabilitation Medicine, CHA Bundang Medical Center	Seongnam		Korea, Republic of	13496

Sponsors and Collaborators

• Bundang CHA Hospital

Investigators

• Principal Investigator: MinYoung Kim, MD, PhD, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MinYoung Kim, MD, PhD, Principal professor of Rehabilitation Medicine, Bundang CHA Hospital
• ClinicalTrials.gov Identifier: NCT04320108
• Other Study ID Numbers: ESWTbraindamage
• First Posted: Mar 24, 2020
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MinYoung Kim, MD, PhD, Principal professor of Rehabilitation Medicine, Bundang CHA Hospital: Extracorporeal shockwave therapy; Brain damage; Pain
• Additional relevant MeSH terms: Shoulder Pain; Brain Injuries; Hypoxia, Brain

Study Results

No Results Posted as of Nov 4, 2020