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

40 Participants Needed

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment ESWT + BoNTA for Upper Limb Spasticity?

Research shows that combining extracorporeal shock wave therapy (ESWT) with botulinum toxin type A (BoNT-A) can be effective in reducing muscle tightness in conditions like cerebral palsy and post-stroke spasticity. Studies suggest that this combination may offer benefits over using BoNT-A alone. ^{1 2 3 4 5}

Is the combination of extracorporeal shock wave therapy and botulinum toxin safe for treating spasticity?

Research suggests that using extracorporeal shock wave therapy (ESWT) and botulinum toxin type A (BoNT-A) together is generally safe for treating spasticity in conditions like stroke, cerebral palsy, and multiple sclerosis. These treatments have been studied in both children and adults, and no major safety concerns have been reported. ^{1 2 3 4 6}

How is the ESWT + BoNTA treatment different from other treatments for upper limb spasticity?

The ESWT + BoNTA treatment combines extracorporeal shock wave therapy (ESWT) with botulinum toxin type A (BoNTA), which may enhance the effects of BoNTA and potentially prolong its benefits. This combination is unique because it uses both a physical therapy (ESWT) and a drug (BoNTA) to address spasticity, which could offer improved outcomes compared to using BoNTA alone. ^{1 2 4 6 7}

Research Team

Lalith Satkunam, MD

Principal Investigator

Alberta University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. England 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasonographic Evaluation for the Effect of Extracorporeal Shock Wave Therapy on Gastrocnemius Muscle Spasticity in Patients With Chronic Stroke. [2020]

4. Italy pubmed.ncbi.nlm.nih.gov

A systematic review on extracorporeal shock wave therapy and botulinum toxin for spasticity treatment: a comparison on efficacy. [2023]

5. United Arab Emirates 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. [2020]

6. Italy pubmed.ncbi.nlm.nih.gov

Synergic use of botulinum toxin injection and radial extracorporeal shockwave therapy in Multiple Sclerosis spasticity. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Budget impact analysis of botulinum toxin A therapy for upper limb spasticity in the United Kingdom. [2020]