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RECRUITING

NCT05226637

Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.

Sponsor: University of Alberta

View on ClinicalTrials.gov

Summary

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.

Official title: 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?

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-04-29

Completion Date

2026-12

Last Updated

2026-04-13

Healthy Volunteers

Conditions

Spasticity, Muscle

Interventions

DEVICE

ESWT (extra-corporeal shock wave therapy)

The ESWT device (Storz Medical Duolith SD1),

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.

Inclusion Criteria: * People with upper limb Spasticity of Cerebral Origin, including but not limited to: * Acquired brain injury (of at least 1 year following the event); * Stroke; * Cerebral Palsy (CP); * Male and females over 18 years of age. * Female subjects must either be post-menopausal, sterilized (at least 12 months post menses) or be consistently using a highly effective method of birth control 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. * 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 consent; * 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 treatment with BoNTA to an affected arm 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. Exclusion Criteria: * 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; * Surgery received to affected arm that may affect assessment of the target joint; * Any changes in either oral or focally injected medications one month prior to screening to close out, that could influence any outcome measures; * 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; * 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; * 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.

Locations (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada