Spastic TetraplegiaNCT04319679
ESWT for UE Pain in Patients With Cervical Spinal Cord Injury
A study testing Extracorporeal shockwave therapy in people with Spastic Tetraplegia and Pain, 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
- Spastic Tetraplegia, Pain, Myelopathy Cervical
- 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
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jun 2020to 13 Apr 2021
- 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
- Spinal cord damage confirmed in the spinal cord image
- 1 month after spinal cord injury
- Spasticity of upper extremities
- Pain in areas below spinal cord injury 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, 13496
About this study
Official title: The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
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/m^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy
- Conditions
- Spastic Tetraplegia, Pain, Myelopathy Cervical
- Being tested
- Extracorporeal shockwave therapy, Sham therapy
- Keywords
- Extracorporeal shockwave therapy, Cervical myelopathy, Spasticity, Pain
- Medical subject headings
- Quadriplegia, Pain, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shockwave therapyDevice
6 times during 2 weeks
Sham therapyDevice
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: Sham 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 (3)
Modified Ashworth scale (MAS)
Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)
Measured: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Range of motion (ROM)
Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)
Measured: Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
Grasp power
Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)
Measured: Up to 4 weeks (baseline, 2 weeks, 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 start5 Jun 2020
- Primary completion5 Apr 2021
- Study completion13 Apr 2021
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic TetraplegiaStudies 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
- 4 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
- Kyunghoon Min, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319679
- Sponsor's protocol ID
- ESWTSCIPain
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information that cannot be identified
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04319679
- Acronym / sponsor ID
- ESWTSCIPain
- Conditions
- Spastic Tetraplegia, Pain, Myelopathy Cervical
- Keywords
- Extracorporeal shockwave therapy, Cervical myelopathy, Spasticity, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (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/m^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy
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: Sham therapySham therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal cord damage confirmed in the spinal cord image
- 1 month after spinal cord injury
- Spasticity of upper extremities
- Pain in areas below spinal cord injury 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)
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 therapy6 times during 2 weeks | Device | Experimental group |
| Sham therapy6 times during 2 weeks | Device | Control 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)
3 secondary outcomes
Modified Ashworth scale (MAS)
Time frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Range of motion (ROM)
Time frame: Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
Grasp power
Time frame: Up to 4 weeks (baseline, 2 weeks, 4 weeks)
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Yes. Information that cannot be identified
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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.
Kyunghoon Min, 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 Spastic Tetraplegia and Pain, 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 7 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: stopped early, as of the sponsor's last update on 14 Apr 2021. 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 was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
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 14 Apr 2021.