StrokeNCT05889026
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
A study testing Extracorporeal shock wave therapy and Botulinum toxin treatment in people with Stroke and Hemiplegia, Spastic, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia, Spastic, Muscle Spasticity
- What is being tested?
- Extracorporeal shock wave therapy and Botulinum toxin treatment
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Aug 2020to 8 Sep 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 6 weeks after stroke diagnosis
- upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2
- ability to stand and walk safely without help or assistance
Who cannot join
- improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- previous contracture and/or deformity of the upper extremities
- concurrent peripheral neuropathy and/or myopathy
- difficulty in participating in the study due to cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials
There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.
Read the detailed description
If the study results can be drawn that the group receiving extracorporeal shock wave therapy along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and lengthen the treatment period compared to the group with botulinum toxin treatment only, it can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was carried out with the expectation that it would be possible to provide a basis for this.
- Conditions
- Stroke, Hemiplegia, Spastic, Muscle Spasticity
- Being tested
- Extracorporeal shock wave therapy, Botulinum toxin treatment
- Medical subject headings
- Stroke, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyDevice
Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.
Botulinum toxin treatmentProcedure or surgery
The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin treatment with extracorporeal shock wave therapy | Active comparator | Nabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles.
ESWT was performed immediately after botulinum toxin injection and was performed once a day for 5 days. Three weeks and 3 months after ESWT, spasticity was evaluated. Receives: Device: Extracorporeal shock wave therapy; Procedure: Botulinum toxin treatment |
| Botulinum toxin treatment only | Sham comparator | Nabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. Three weeks and 3 months after Botox treatment, spasticity was evaluated. Receives: Procedure: Botulinum toxin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified ashworth scale of upper extremities spasticity
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Measured: Pre-treatment (baseline)
Modified ashworth scale of upper extremities spasticity
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Measured: Three weeks after treatment
Modified ashworth scale of upper extremities spasticity
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Measured: Three months after treatment
Secondary outcomes (11)
Modified tardieu scale of upper extremities spasticity
Unit : degree / higher degree means little limitation of range of motion
Measured: Pre-treatment (baseline)
Modified tardieu scale of upper extremities spasticity
Unit : degree / higher degree means little limitation of range of motion
Measured: Three weeks after treatment
Modified tardieu scale of upper extremities spasticity
Unit : degree / higher degree means little limitation of range of motion
Measured: Three months after treatment
Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity
Minimum score 0, maximum score 66 / higher score means better function of upper extremity
Measured: Pre-treatment (baseline)
Fugl-Meyer assessment of upper extremity
Minimum score 0, maximum score 66 / higher score means better function of upper extremity
Measured: Three months after treatment
Action research arm test
Minimum score 0, maximum score 57 / higher score means better function of upper extremity
Measured: Pre-treatment (baseline)
Action research arm test
Minimum score 0, maximum score 57 / higher score means better function of upper extremity
Measured: Three weeks after treatment
Action research arm test
Minimum score 0, maximum score 57 / higher score means better function of upper extremity
Measured: Three months after treatment
Modified barthel index
Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living
Measured: Pre-treatment (baseline)
Modified barthel index
Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living
Measured: Three weeks after treatment
Modified barthel index
Minimum score 0, maximum score 100 (if w/c ambulation, 90) / higher score means better capacity for activities of daily living
Measured: Three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start6 Aug 2020
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889026
- Sponsor's protocol ID
- ESWT RCT
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity: Preliminary Study, Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT05889026
- Acronym / sponsor ID
- ESWT RCT
- Conditions
- Stroke, Hemiplegia, Spastic, Muscle Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 5 Jun 2023 (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.
There are few studies on whether botulinum toxin treatment and extracorporeal shock wave therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.
Detailed description
If the study results can be drawn that the group receiving extracorporeal shock wave therapy along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and lengthen the treatment period compared to the group with botulinum toxin treatment only, it can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was carried out with the expectation that it would be possible to provide a basis for this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin treatment with extracorporeal shock wave therapy | Active comparator | Device: Extracorporeal shock wave therapy, Procedure: Botulinum toxin treatmentNabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. ESWT was performed immediately after botulinum toxin injection and was performed once a day for 5 days. Three weeks and 3 months after ESWT, spasticity was evaluated. |
| Botulinum toxin treatment only | Sham comparator | Procedure: Botulinum toxin treatmentNabota® (Daewoong Pharmaceutical Co. Ltd., Seoul, Korea) was used. It was diluted with 0.9% sodium chloride solution and injected into the bellies of the upper-extremity muscles. Three weeks and 3 months after Botox treatment, spasticity was evaluated. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 6 weeks after stroke diagnosis
- upper-extremity (elbow, wrist and finger) spasticity Modified Ashworth Scale (MAS) score > 2
- ability to stand and walk safely without help or assistance
Key exclusion criteria (4 listed)
- improper indication for botulinum toxin A (BTxA) injection, for example, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- previous contracture and/or deformity of the upper extremities
- concurrent peripheral neuropathy and/or myopathy
- difficulty in participating in the study due to cognitive impairment.
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 shock wave therapyStimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2. | Device | Botulinum toxin treatment with extracorporeal shock wave therapy |
| Botulinum toxin treatmentThe toxin dose was established for each patient: it ranged between 80 unit and 300 unit. | Procedure or surgery | Botulinum toxin treatment only, Botulinum toxin treatment with extracorporeal shock wave therapy |
Primary outcome
Modified ashworth scale of upper extremities spasticity
Time frame: Pre-treatment (baseline)
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Modified ashworth scale of upper extremities spasticity
Time frame: Three weeks after treatment
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
Modified ashworth scale of upper extremities spasticity
Time frame: Three months after treatment
minimum grade 0, maximum grade 4 / higher grade means severe spasticity
11 secondary outcomes
Modified tardieu scale of upper extremities spasticity
Time frame: Pre-treatment (baseline)
Modified tardieu scale of upper extremities spasticity
Time frame: Three weeks after treatment
Modified tardieu scale of upper extremities spasticity
Time frame: Three months after treatment
Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity Fugl-Meyer assessment of upper extremity
Time frame: Pre-treatment (baseline)
Fugl-Meyer assessment of upper extremity
Time frame: Three months after treatment
Action research arm test
Time frame: Pre-treatment (baseline)
Action research arm test
Time frame: Three weeks after treatment
Action research arm test
Time frame: Three months after treatment
Modified barthel index
Time frame: Pre-treatment (baseline)
Modified barthel index
Time frame: Three weeks after treatment
Modified barthel index
Time frame: Three months after treatment
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 5 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 shock wave therapy and Botulinum toxin treatment in people with Stroke and Hemiplegia, Spastic, run by Korea University Guro 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 3 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 5 Jun 2023. 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?
Modified ashworth scale of upper extremities spasticity (time frame: Pre-treatment (baseline)). The study lists 3 primary outcomes in all. 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 5 Jun 2023.