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ESWT + BoNTA for Upper Limb Spasticity

N/A
Recruiting
Led By Lalith E Satkunam, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 12 and 24 weeks from baseline
Awards & highlights

Study Summary

This trial is testing whether adding extra-corporeal shock wave therapy to botulinum neurotoxin A will demonstrate greater clinical and patient reported outcomes compared to standard treatment with botulinum neurotoxin A alone for people with spasticity post-stroke or TBI.

Who is the study for?
Adults over 18 with upper limb spasticity due to conditions like stroke or cerebral palsy, who haven't had shockwave therapy before. They must have a certain level of muscle stiffness and be able to answer questionnaires. Women must use effective birth control or be post-menopausal.Check my eligibility
What is being tested?
The study tests if adding ESWT (shock wave therapy) to standard BoNTA (Botulinum Neurotoxin A) treatment offers better outcomes for managing upper limb spasticity compared to just BoNTA alone. Participants are randomly placed in two groups, one receiving ESWT plus BoNTA and the other receiving sham treatment plus BoNTA.See study design
What are the potential side effects?
Possible side effects may include pain at the site of shockwave application, minor bruising, swelling, numbness or tingling in the treated arm. These are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stopped BoNTA treatment for 3 months or plan to start it for my affected arm.
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I have stopped BoNTA treatment for 3 months or plan to start it for my arm.
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My arm is stiff, making it hard to move my elbow.
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I have never undergone shockwave therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 12 and 24 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 12 and 24 weeks from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in clinical passive range of motion at the elbow joint treated side with goniometer at weeks 4, 12 and 24.
Muscle Spasticity
Secondary outcome measures
Change from baseline of patient reported outcomes quality of life on EQ-5D-5L questionnaire at weeks 4, 12 and 24.
Change from baseline on spasticity level on Modified Ashworth Scale (MAS) at 4, 12 and 24 weeks
Other outcome measures
Feasibility of the project measured by the percentage of participants without any missing data at the end of the study and percentage of participant who completed the study.
Measure the acceptability of the procedure (ESWT) throughout the study using a pain numerical rating scale (NRS).

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental group with ESWTExperimental Treatment1 Intervention
The randomly selected Study group will be comprised of patients who will receive the appropriate treatment with BoNTA in addition to actual ESWT (extra-corporeal shock wave therapy. ESWT is an existing technology that uses a device that generates high intensity shockwaves. These shock waves are generated outside of the body (extra corporeal) but penetrate through the skin surface to underlying structures and tissue. ESWT has been historically used safely and for many years to treat common musculoskeletal (MSK) conditions. For the purpose of the study these variables are standardized. We will treated with the Storz Duolith SD1 and we will use the D15 head 3000 number of shocks, 2.5 bar, 15 Hz over the same area of upper extremity described for the control group.
Group II: Control groupPlacebo Group1 Intervention
In addition to standard of care, with BoNTA injections, the randomly selected control group will be treated with a sham head to the flexor muscles of the upper extremity. The sham component made by the manufacturers is designed such that the internal pneumatic projectile is physically blocked from providing high energy impact with the contact surface, however the handset looks and sounds identical. In doing so, the sham head still actuates and makes the same sounds but produces no shockwave ESWT will be apply on every candidate over the anterior region of the upper extremity injected with the BoNTA.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,918 Total Patients Enrolled
Lalith E Satkunam, MDPrincipal InvestigatorAlberta University

Media Library

Experimental group with ESWT Clinical Trial Eligibility Overview. Trial Name: NCT05226637 — N/A
Spasticity Research Study Groups: Experimental group with ESWT, Control group
Spasticity Clinical Trial 2023: Experimental group with ESWT Highlights & Side Effects. Trial Name: NCT05226637 — N/A
Experimental group with ESWT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226637 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation rate of this experiment?

"That's correct. According to clinicaltrials.gov, this experiment commenced on April 29th 2022 and is still searching for applicants - 40 participants must be recruited from a single medical facility."

Answered by AI

Is the opportunity to join this research still available for those interested?

"According to the clinicaltrials.gov portal, this research is currently in its recruitment stage. The trial was first announced on April 29th 2022 and has since been last modified on July 14th of the same year."

Answered by AI

Is admittance to this trial limited to those above a certain age?

"This clinical trial demands that participants are between 18 and 99 years of age. 19 studies will involve those younger than 18, while 51 will be offered to individuals over 65."

Answered by AI

Is there any possibility of me joining this medical study?

"This clinical trial seeks to enrol 40 individuals aged 18-99 who suffer from spasticity in the muscles, stroke, cerebral palsy (CP), and acquired brain injury of at least one year’s duration. Successful applicants must also meet various other criteria such as a Modified Ashworth Scale score of 2 in an affected upper limb joint like their elbow; cognitive capacity to answer basic questions; existing or upcoming 'standard treatment' with BoNTA for three months prior to ESWT administration; female candidates must either be postmenopausal, sterilized (at least 12 months post menses) or consistently use effective contraception methods; and"

Answered by AI

Who else is applying?

What site did they apply to?
Glenrose Rehabilitation Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.
2022. "Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226637.
~18 spots leftby Dec 2025
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