Brain Damage, HypoxicNCT04320108
ESWT for Shoulder Pain in Patients With Brain Damage
A study testing Extracorporeal shockwave therapy in people with Brain Damage, Hypoxic and Stroke, run by Bundang CHA Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Brain Damage, Hypoxic, Stroke, Brain Tumor
- What is being tested?
- Extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2020to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pain due to trauma
- Injection treatments two weeks before participating in the study
- Severe coagulopathy (excluding antiplatelet use)
- Impaired cognition
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, CHA Bundang Medical Center
Seongnam, South Korea, 13496
About this study
Official title: The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage
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.
Read the 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
- Conditions
- Brain Damage, Hypoxic, Stroke, Brain Tumor, ICH
- Being tested
- Extracorporeal shockwave therapy
- Keywords
- Extracorporeal shockwave therapy, Brain damage, Pain
- Medical subject headings
- Hypoxia, Brain, Stroke, Brain Neoplasms, Brain Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapyDevice
Extracorporeal shockwave therapy 6 times during 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range Receives: Device: Extracorporeal shockwave therapy |
| Control group | Sham comparator | Sham therapy Receives: Device: Extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
Pain intensity (0-10, ordinal scale)
Measured: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary outcomes (1)
Shoulder Pain and Disability Index (SPADI)
Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst)
Measured: Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start29 May 2020
- Primary completion31 Oct 2021
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Damage, HypoxicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- MinYoung Kim, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320108
- Sponsor's protocol ID
- ESWTbraindamage
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2020
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage
- ClinicalTrials.gov ID
- NCT04320108
- Acronym / sponsor ID
- ESWTbraindamage
- Conditions
- Brain Damage, Hypoxic, Stroke, Brain Tumor, ICH
- Keywords
- Extracorporeal shockwave therapy, Brain damage, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Extracorporeal shockwave therapy3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range |
| Control group | Sham comparator | Device: Extracorporeal shockwave therapySham therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Pain due to trauma
- Injection treatments two weeks before participating in the study
- Severe coagulopathy (excluding antiplatelet use)
- Impaired cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shockwave therapyExtracorporeal shockwave therapy 6 times during 2 weeks | Device | Control group, Experimental group |
Primary outcome
Numerical rating scale (NRS)
Time frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Pain intensity (0-10, ordinal scale)
1 secondary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MinYoung Kim, MD, PhD principal investigator
Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shockwave therapy in people with Brain Damage, Hypoxic and Stroke, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.