Post-Stroke Upper Limb SpasticityNCT03131791
Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity
A study testing Shock Wave and Botulinum toxin A in people with Post-Stroke Upper Limb Spasticity, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Stroke Upper Limb Spasticity
- What is being tested?
- Shock Wave and Botulinum toxin A
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2017to 30 Sep 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-80 year-old
- The onset of stroke must be at least 6 months previously
- Spasticity measured as Modified Asthow Scale more(MAS) than 1+
- Signed informed consent form
Who cannot join
- Patients with marked contractures in the elbow and wrist (MAS>4)
- Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
- Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
Read the detailed description
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
- Conditions
- Post-Stroke Upper Limb Spasticity
- Being tested
- Shock Wave, Botulinum toxin A
- Keywords
- Extracorporeal Shock Wave, Spasticity in stokes, Botulinum toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock WaveDevice
42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
Botulinum toxin ADrug
42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| shock wave | Experimental | The interventions were focused in the hypertonic muscles of the upper limb of 3000 impulses, a pressure of 1.5 bar and frequency of 5Hz were used to treat the biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly. Receives: Device: Shock Wave |
| Botulinum toxin A | Experimental | We performed BoNT-A 500 unit in 2cc 0.9% normal saline at biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly. Receives: Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of spasticity of elbow
Modified Ashworth Scale (MAS) for spasticity
Measured: Between baseline and 4 weeks post-treatment
Secondary outcomes (2)
The change of Tardieu scale scores for the elbow and wrist
Tardieu scale scores for spasticity
Measured: Between baseline and 1, 4,8 weeks post-treatment
The change of upper limb function
The Fugl-Meyer Assessment (FMA) for upper limb function
Measured: Between baseline and 1,4,8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Apr 2017
- Primary completion1 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Stroke Upper Limb SpasticityStudies 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
- Model description
- group A : shock wave, group B: Botulinum Toxin Injection
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwo-Chi Hu,PHD, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131791
- Sponsor's protocol ID
- 16MMHIS066e
- Status last verified
- Aug 2018
- First submitted
- 21 Apr 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu YT, Yu HK, Chen LR, Chang CN, Chen YM, Hu GC. Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2143-2150. doi: 10.1016/j.apmr.2018.05.035. Epub 2018 Jul 4.
PubMed 30392753
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT03131791
- Acronym / sponsor ID
- 16MMHIS066e
- Conditions
- Post-Stroke Upper Limb Spasticity
- Keywords
- Extracorporeal Shock Wave, Spasticity in stokes, Botulinum toxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 27 Apr 2017 (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.
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
Detailed description
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- group A : shock wave, group B: Botulinum Toxin Injection
| Arm | Type | Receives |
|---|---|---|
| shock wave | Experimental | Device: Shock WaveThe interventions were focused in the hypertonic muscles of the upper limb of 3000 impulses, a pressure of 1.5 bar and frequency of 5Hz were used to treat the biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly. |
| Botulinum toxin A | Experimental | Drug: Botulinum toxin AWe performed BoNT-A 500 unit in 2cc 0.9% normal saline at biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18-80 year-old
- The onset of stroke must be at least 6 months previously
- Spasticity measured as Modified Asthow Scale more(MAS) than 1+
- Signed informed consent form
Key exclusion criteria (3 listed)
- Patients with marked contractures in the elbow and wrist (MAS>4)
- Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
- Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study
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 |
|---|---|---|
| Shock Wave42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment. | Device | shock wave |
| Botulinum toxin A42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment. | Drug | Botulinum toxin A |
Primary outcome
The change of spasticity of elbow
Time frame: Between baseline and 4 weeks post-treatment
Modified Ashworth Scale (MAS) for spasticity
2 secondary outcomes
The change of Tardieu scale scores for the elbow and wrist
Time frame: Between baseline and 1, 4,8 weeks post-treatment
The change of upper limb function
Time frame: Between baseline and 1,4,8 weeks post-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 20 Aug 2018.
- Derived from this study: PubMed 30392753Wu YT, Yu HK, Chen LR, Chang CN, Chen YM, Hu GC. Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2143-2150. doi: 10.1016/j.apmr.2018.05.035. Epub 2018 Jul 4.
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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 Shock Wave and Botulinum toxin A in people with Post-Stroke Upper Limb Spasticity, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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 20 Aug 2018. 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 Taiwan. 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. 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?
The change of spasticity of elbow (time frame: Between baseline and 4 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03131791, which also lists 1 linked publication.
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 20 Aug 2018.