Back to resultsESWT for Shoulder Pain in Patients With Brain Damage
Primary Purpose
Brain Damage, Hypoxic, Stroke, Brain Tumor
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shockwave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Damage, Hypoxic focused on measuring Extracorporeal shockwave therapy, Brain damage, Pain
Eligibility Criteria
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
Sites / Locations
- Department of Rehabilitation Medicine, CHA Bundang Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
Sham therapy
Outcomes
Primary Outcome Measures
Numerical rating scale (NRS)
Pain intensity (0-10, ordinal scale)
Secondary Outcome Measures
Shoulder Pain and Disability Index (SPADI)
Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04320108
Brief Title
ESWT for Shoulder Pain in Patients With Brain Damage
Official Title
The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
February 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Damage, Hypoxic, Stroke, Brain Tumor, ICH
Keywords
Extracorporeal shockwave therapy, Brain damage, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham therapy
Intervention Type
Device
Intervention Name(s)
Extracorporeal shockwave therapy
Intervention Description
Extracorporeal shockwave therapy 6 times during 2 weeks
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Description
Pain intensity (0-10, ordinal scale)
Time Frame
Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst)
Time Frame
Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MinYoung Kim, MD, PhD
Phone
82-30-780-6281
Email
kmin@cha.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MinYoung Kim, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, CHA Bundang Medical Center
City
Seongnam
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MinYoung Kim, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
ESWT for Shoulder Pain in Patients With Brain Damage
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