Testing ESWT (extra-corporeal shock wave against a placebo for muscle spasticity
Official title: Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.
Does Extra-corporeal Shock Wave Therapy Combined With Botulinum Toxin Type A Treatment Improve Clinical and Patient Reported Outcomes When Compared to Standard Management (BoNTA) in Patients With Upper Limb Spasticity of Cerebral Origin?
- 2 groups
- One site, in Edmonton
- Recruiting
Interventions
- Medical device
ESWT (extra-corporeal shock wave therapy)
The ESWT device (Storz Medical Duolith SD1),
- Medical device
Sham : The ESWT device (Storz Medical Duolith SD1),
In doing so, the sham head still actuates and makes the same sounds but produces no shockwave. Because the patients receiving this intervention are naïve to ESWT, they will not be biased by the sensation it produces. Communication during treatment will be limited to avoid inadvertent bias.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +People with upper limb Spasticity of Cerebral Origin, including but not limited to:
- +Acquired brain injury (of at least 1 year following the event);
- +Cerebral Palsy (CP);
- +Male and females over 18 years of age.
- +Being naive to shockwave therapy;
- +Spasticity as defined by Modified Ashworth Scale (MAS) score of 2 in a functional or non-functional upper limb affecting the target joint, which for the purpose of the study will be the elbow;
- +Willingness to participate and provide written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +Have the cognitive capacity to answers simple questionnaires;
- +Either already receiving treatment with BoNTA and having been 'washed out' for a period of three months, or intends to begin 'standard treatmentStandard of careThe treatment normally given for a condition outside a study.Read more → with BoNTA to an affected armArmOne of the groups in a study, each receiving something different.Read more → with target joint involvement.
- +Standard treatment in the context of the study will include, in addition to any other therapies, focal treatment with Botulinum Neurotoxin Type A to treat the target joint.
- +Female subjects must either be post-menopausal, sterilized (at least 12 months post menses) or be consistently using a highly effective method of birth controlControl groupThe group a new treatment is measured against.Read more → such as a sterilized partner, oral/implanted/injected contraception or abstinence of sexual activity and be willing to provide a pregnancy test as the safe use of ESWT during pregnancy has not been demonstrated.
Exclusion
- −Known neurodegenerative disorder at the spinal level;
- −Known spinal cord lesion ;
- −Fixed contracture of target joint impeding assessment or MAS of 4;
- −Any demonstrated lower motor neuron damage to the affected limb;
- −Any changes in either oral or focally injected medications one month prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more → to close out, that could influence any outcome measuresEndpointThe specific thing a study measures to answer its question.Read more →;
- −Any changes in medication one month prior to screening to close out, for the treatment of depression as changes in patient affect may influence outcome measures;
- −Any changes in rehabilitation therapy throughout the study cycles;
- −Implanted electronic device/s. Kinetic energy in the same territory as an implanted device may adversely affect the device's function;
- −Patients taking Warfarin and have poorly controlled coagulopathy or an INR above 3 at the Point of Care. To avoid hematoma, compartment syndrome or other consequences of prolonged bleeding to treated area. This is also the same program criteria for injection with BoNTA. For this population INR will be determined (using the Coguchek XL device) prior to each treatment;
- −Any malignant diagnoses. Tissue disruption caused by the shockwave treatment may precipitate the liberation or shedding of cancer cells;
- −Any known infection, inflammatory process, open areas or acute undiagnosed swelling (acute being defined as 14 days or sooner) in the area treated to avoid worsening of any pre-existing condition;
- −Participation in any other concurrent study.
- −Confirmed pregnancy. Safe use in this population remains unknown;
- −Nursing mothers. Safe use in this population remains unknown;
- −Female patients who are of childbearing age without adequate contraception and unwilling to take a pregnancy test;
- −Surgery received to affected armArmOne of the groups in a study, each receiving something different.Read more → that may affect assessment of the target joint;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Sham : The ESWT device (Storz Medical Duolith SD1),.
Registry label: A: Control group
Group B receives ESWT (extra-corporeal shock wave therapy).
Registry label: B: Experimental group with ESWT
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 99 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 4, 12 and 24 weeks from the baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in patient reported outcomes of spasticity on Numerical Rating Scale (NRS) for Spasticity at weeks 4, 12 and 24 — measured over 4, 12 and 24 weeks from the baseline.
Change from baseline in clinical passive range of motion at the elbow joint treated side with goniometer at weeks 4, 12 and 24 — measured over 4, 12 and 24 weeks from the baseline.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05226637 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ESWT (extra-corporeal shock wave therapy)Device
The ESWT device (Storz Medical Duolith SD1),
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Sham : The ESWT device (Storz Medical Duolith SD1),Device
In doing so, the sham head still actuates and makes the same sounds but produces no shockwave. Because the patients receiving this intervention are naïve to ESWT, they will not be biased by the sensation it produces. Communication during treatment will be limited to avoid inadvertent bias.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 99 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 99 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4, 12 and 24 weeks from the baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Background Effective management of spasticity, a debilitating and challenging condition afflicting many recovering from and living with neurological conditions, may reduce long term consequences such as limb contracture, skin breakdown, compromised mobility, caregiver burden and discomfort. In rehabilitation, spasticity represents a significant barrier to successful rehabilitation outcomes. Effective spasticity management can increases the length of individual functional status, reduces equipment/care needs, hospital admissions and extends the time people can stay safely at home, which would represent an economic benefit to the health system. Extra-corporeal Shock Wave Therapy (ESWT), an intense short energy wave delivered directly at the region of affected muscles has, in past randomized controlled studies, demonstrated positive outcomes for this population (spastic stroke population, TBI), on its own and as an adjunct to current modalities. In fact, one retrospective observational study demonstrated an increased efficacy of Toxin botulinum at 1 month when combined with ESWT. Where existing treatment options may be limited by coverage, access to delivery, complications and side effects, ESWT represents a potential to be a safe, low cost, efficacious alternative that can be administered by any trained clinician. Aims The aims of this pilot study will be to explore the hypothesis that adding ESWT to Botulinum Neurotoxin A (BoNTA) in spasticity post-stroke (TBI)will demonstrate greater clinical and patient reported outcomes compared to standard treatment with BoNTA alone, a comparison only once previously studied. Methods Incorporating randomization and placebo control (n= 20 in each arm), this patient-centric study will examine treatment goals and holistic perception of benefit after the treatment experience. We will use patient reported outcomes at baseline and at defined intervals after intervention. We will test our hypothesis using clinical and patient reported scales, such as the patient reported numeric rating scale (NRS) and goniometric range for spasticity as our primary outcome in conjunction with measures of muscle stiffness, quality of life, feasibility and acceptability of the protocol to help inform future study direction.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.