Post-Stroke Elbow SpasticityPhase 4NCT02358005
Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
A Phase 4 study testing Extracorporeal shock wave therapy 60mj, Extracorporeal shock wave therapy 120mj and non extracorporeal shock wave therapy in people with Post-Stroke Elbow Spasticity, run by Yonsei University at 1 site in South Korea.
Trial summary
Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-Stroke Elbow Spasticity
- What is being tested?
- Extracorporeal shock wave therapy 60mj, Extracorporeal shock wave therapy 120mj and non extracorporeal shock wave therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Aug 2019
- Phase
- Phase 4
- 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
- Male or female
- Age ≥20 years
- inpatients
- Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii
- Modified Ashworth scale (MAS) ≥2,
- At least a 3-month period from stroke,
- Written informed consent has been obtained
Who cannot join
- Fixed contractures and/or deformities at the elbow,
- Previous fractures of the paretic upper limb,
- Peripheral nervous system disorders/myopathies,
- Previous BTX-A treatment and/or ESWT,
- Structural alterations in the soft tissue (e.g., fibrosis),
- Known allergy or sensitivity to the study medication or its components
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- Presence of an unstable medical condition or uncontrolled systemic disease
- Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function.
- Bleeding tendency and/or anticoagulation therapy
- Presence of infection or skin disorder at injection sites
- Females were are pregnant, nursing, or are planning a pregnancy during the study
- Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception
- Participant who should be withdrawn from the study in the opinion of the investigator for any reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Healthcare System, Severance Hospital
Seoul
Yong Wook Kim, MD, +82 2-2228-3716, YWKIM1@yuhs.ac
About this study
Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity
- Conditions
- Post-Stroke Elbow Spasticity
- Being tested
- Extracorporeal shock wave therapy 60mj, Extracorporeal shock wave therapy 120mj, non extracorporeal shock wave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy 60mjProcedure or surgery
Extracorporeal shock wave therapy 120mjProcedure or surgery
non extracorporeal shock wave therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 60mJ ESWT | Experimental | ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ Receives: Procedure: Extracorporeal shock wave therapy 60mj |
| 120mJ ESWT | Experimental | ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ Receives: Procedure: Extracorporeal shock wave therapy 120mj |
| sham ESWT stimulation | Placebo comparator | ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ Receives: Procedure: non extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM) of elbow flexor
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke Elbow SpasticityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358005
- Sponsor's protocol ID
- 4-2014-0925
- Status last verified
- Feb 2019
- First submitted
- 23 Jan 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
- ClinicalTrials.gov ID
- NCT02358005
- Acronym / sponsor ID
- 4-2014-0925
- Conditions
- Post-Stroke Elbow Spasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 6 Feb 2015 (estimated)
- 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.
Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60mJ ESWT | Experimental | Procedure: Extracorporeal shock wave therapy 60mjESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ |
| 120mJ ESWT | Experimental | Procedure: Extracorporeal shock wave therapy 120mjESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ |
| sham ESWT stimulation | Placebo comparator | Procedure: non extracorporeal shock wave therapyESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Age ≥20 years
- inpatients
- Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii
- Modified Ashworth scale (MAS) ≥2,
Key exclusion criteria (13 listed)
- Fixed contractures and/or deformities at the elbow,
- Previous fractures of the paretic upper limb,
- Peripheral nervous system disorders/myopathies,
- Previous BTX-A treatment and/or ESWT,
- Structural alterations in the soft tissue (e.g., fibrosis),
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 therapy 60mj | Procedure or surgery | 60mJ ESWT |
| Extracorporeal shock wave therapy 120mj | Procedure or surgery | 120mJ ESWT |
| non extracorporeal shock wave therapy | Procedure or surgery | sham ESWT stimulation |
Primary outcome
Range of Motion (ROM) of elbow flexor
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extracorporeal shock wave therapy 60mj, Extracorporeal shock wave therapy 120mj and non extracorporeal shock wave therapy in people with Post-Stroke Elbow Spasticity, run by Yonsei University 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 13 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Wook Kim, MD (+82 -2-2228-3716, YWKIM1@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) of elbow flexor (time frame: 5 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 26 Feb 2019.