ESWT + BoNTA for Upper Limb Spasticity

Overseen By Steacy Wray, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Botulinum Neurotoxin A

Must not be taking: Warfarin

Disqualifiers: Neurodegenerative disorder, Spinal cord lesion, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treat upper limb spasticity, a condition where muscles become overly tight and stiff, often affecting individuals after a stroke or with cerebral palsy. The trial compares the effects of adding Extra-corporeal Shock Wave Therapy (ESWT) to the usual treatment with Botulinum Neurotoxin A (BoNTA). Participants will receive either the combination therapy or BoNTA with a sham (inactive) version of ESWT. Individuals with upper limb spasticity due to conditions like stroke or cerebral palsy, who have not previously undergone shockwave therapy, might be suitable for this trial. The goal is to determine if the combination therapy offers better results in managing muscle stiffness and improving quality of life. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that any changes in medications one month prior to screening could affect eligibility. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this protocol is safe for managing upper limb spasticity?

Research shows that Extra-corporeal Shock Wave Therapy (ESWT) has been safely used to treat muscle problems and reduce pain. Studies have found it can help with muscle stiffness after brain or spinal cord injuries, such as those from strokes.

Many people have tolerated ESWT well, with few serious side effects reported. For instance, one study found that combining ESWT with Botulinum Neurotoxin A (BoNTA) increased its effectiveness without adding significant risks.

ESWT has a long history of treating various muscle and bone issues. This history suggests it is generally safe when performed by trained professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Extra-corporeal Shock Wave Therapy (ESWT) combined with BoNTA for treating upper limb spasticity because ESWT offers a unique, non-invasive approach. Unlike traditional treatments that may rely solely on medications or injections, ESWT uses high-intensity shock waves from outside the body to target and penetrate tissues. This novel mechanism can potentially enhance the effectiveness of standard treatments like BoNTA by improving muscle relaxation and reducing spasticity more efficiently. Additionally, the non-invasive nature of ESWT means it could offer fewer side effects and quicker recovery times compared to more invasive procedures.

What evidence suggests that this trial's treatments could be effective for upper limb spasticity?

This trial will compare the effects of Extra-corporeal Shock Wave Therapy (ESWT) combined with Botulinum Neurotoxin A (BoNTA) to a control group receiving a sham ESWT treatment. Research has shown that ESWT can help reduce upper limb spasticity, a condition where muscles become too tight and stiff. One study found that using ESWT along with regular therapy provided extra benefits for managing muscle stiffness. Previous research also found that combining ESWT with BoNTA led to even better results, possibly enhancing the effects of BoNTA. ESWT has also been shown to reduce pain and aid healing in various muscle and joint conditions. These findings suggest that ESWT, especially when used with BoNTA, could be a promising way to improve outcomes for people with spasticity. ^{2 3 4 6 7}

Who Is on the Research Team?

Lalith Satkunam, MD

Principal Investigator

Alberta University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have arm stiffness due to a brain condition like stroke or cerebral palsy.

I have stopped BoNTA treatment for 3 months or plan to start it for my affected arm.

I will receive Botulinum Neurotoxin Type A for my joint as part of the study treatment.

Exclusion Criteria

You are breastfeeding. It's not known if the study drug is safe for nursing mothers.

I am of childbearing age and not using or willing to use birth control, nor will I take a pregnancy test.

I have a diagnosed spinal cord lesion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4-6 weeks

1 visit (in-person)

Treatment

Participants receive ESWT combined with BoNTA or sham treatment over 10-11 visits

12 weeks

10-11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

Long-term Follow-up

Participants are assessed for long-term outcomes and adherence to protocol

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extra-corporeal Shock Wave Therapy (ESWT)
• Sham : The ESWT device (Storz Medical Duolith SD1)

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental group with ESWT Experimental Treatment 1 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 group Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a study involving 10 children with spastic cerebral palsy, the combination of botulinum toxin type A (BoNT-A) and extracorporeal shock wave therapy (ESWT) showed significant improvements in muscle hardness and spasticity compared to BoNT-A alone.

The results suggest that combining BoNT-A with ESWT may enhance treatment effectiveness by targeting both neurological and muscle properties, as indicated by significant differences in clinical assessments after one month.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonographic and clinical effects of botulinum toxin Type A combined with extracorporeal shock wave therapy on spastic muscles of children with cerebral palsy. Picelli, A., La Marchina, E., Gajofatto, F., et al.[2018]

Extracorporeal shock wave therapy (ESWT) and botulinum toxin type A (BoNT-A) both effectively reduce spasticity in patients with conditions like post-stroke, multiple sclerosis, and cerebral palsy, as measured by various scales including the Modified Ashworth Scale and the Modified Tardieu Scale.

The systematic review included five studies and highlighted the need for further research to solidify these findings and improve study protocols for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on extracorporeal shock wave therapy and botulinum toxin for spasticity treatment: a comparison on efficacy. Mihai, EE., Popescu, MN., Iliescu, AN., et al.[2023]

Extracorporeal shock wave therapy (ESWT) is shown to be noninferior to botulinum toxin type A (BoNT-A) in reducing upper limb spasticity in post-stroke patients, based on a study of 42 participants.

While both treatments effectively reduced spasticity, ESWT resulted in greater improvements in wrist and elbow passive range of motion and overall upper extremity function, as measured by the Fugl-Meyer Assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial. Wu, YT., Yu, HK., Chen, LR., et al.[2019]

In a study involving 16 MS patients, Botulinum NeuroToxin Type A (BoNT-A) significantly reduced spasticity, but its effects diminished after four months; however, combining BoNT-A with radial extracorporeal shock wave therapy (rESWT) helped prolong its benefits.

The addition of rESWT not only maintained the reduction in spasticity but also improved both passive and active range of motion in the ankle, suggesting that this combination therapy could enhance the overall effectiveness of BoNT-A in managing MS-related spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergic use of botulinum toxin injection and radial extracorporeal shockwave therapy in Multiple Sclerosis spasticity. Marinaro, C., Costantino, C., D'Esposito, O., et al.[2023]

A single session of extracorporeal shock wave therapy (ESWT) significantly improved spasticity in patients with chronic stroke, as measured by the Modified Ashworth Scale and various ultrasonographic measures, with the most notable improvements observed at the 4-week follow-up.

The study involved 18 participants and demonstrated that ESWT led to measurable changes in muscle characteristics, such as muscle fascicle length and pennation angle, indicating its potential efficacy in managing spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonographic Evaluation for the Effect of Extracorporeal Shock Wave Therapy on Gastrocnemius Muscle Spasticity in Patients With Chronic Stroke. Lee, CH., Lee, SH., Yoo, JI., et al.[2020]

In a study of 30 post-stroke patients, combining botulinum toxin type A with radial Extracorporeal Shock Wave Therapy (rESWT) showed significant improvements in spasticity and muscle tone compared to botulinum toxin alone, particularly noticeable after one month.

Both treatment groups experienced reductions in spasticity and pain over three months, but the combination therapy group had more pronounced effects at the one-month mark, suggesting rESWT may enhance the efficacy of traditional treatments for spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and Muscles Properties Modifications After Botulinum Toxin Type A (BTX-A) and Radial Extracorporeal Shock Wave (rESWT) Combined Treatment. Megna, M., Marvulli, R., Farì, G., et al.[2020]

Increasing the use of abobotulinumtoxinA for treating upper limb spasticity (ULS) could save the UK healthcare system approximately £6.28 million over five years, compared to other formulations of botulinum toxin A.

AbobotulinumtoxinA is more cost-effective than onabotulinumtoxinA and incobotulinumtoxinA, with annual treatment costs of £19,800 compared to £20,861 and £20,717 respectively, indicating a financial benefit for patients and the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget impact analysis of botulinum toxin A therapy for upper limb spasticity in the United Kingdom. Abogunrin, S., Hortobagyi, L., Remak, E., et al.[2020]

Citations

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Researchers demonstrated the use of ESWT to reduce pain and promote healing in bone, tendon, ligament and fascia in patients with musculoskeletal disorders.

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The primary outcome was upper limb spasticity and functionality, although additional outcomes measured before and at any time following extra- corporeal shock ...

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Conclusions: ESWT may be an effective and safe treatment for spasticity after upper motor neuron injury. However, due to poor methodological ...