Improving upper limb spasticity treatment with shock wave therapy and Botox.

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?

This study is testing if combining shock wave therapy with Botox can help people with upper limb spasticity from conditions like stroke or cerebral palsy feel better than standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Alberta (other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05226637 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Extra-corporeal Shock Wave Therapy (ESWT) combined with Botulinum Toxin A (BoNTA) in treating upper limb spasticity compared to standard management. Conducted at the Glenrose Rehabilitation Hospital in Edmonton, Canada, the study will enroll participants with upper limb spasticity due to conditions like stroke or cerebral palsy. Participants will undergo a series of 10-11 visits for treatment and assessment, with data collected to evaluate the outcomes of the combined therapy. The goal is to determine if this innovative approach can enhance rehabilitation outcomes and reduce the burden of spasticity.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with upper limb spasticity of cerebral origin, such as those recovering from stroke or brain injuries.

Not a fit: Patients who are not naive to shockwave therapy or those with spasticity not affecting the elbow may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve functional outcomes and quality of life for patients with upper limb spasticity.

How similar studies have performed: Previous studies have shown positive outcomes for ESWT in similar populations, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Edmonton, Alberta

• Glenrose Rehabilitation Hospital — Edmonton, Alberta, Canada (RECRUITING)

Study contacts

• Principal investigator: Lalith E Satkunam, MD — Alberta University
• Study coordinator: Steacy Wray, RN

Conditions: Spasticity, Muscle