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

Condition(s) studied

Investigational drug(s) / intervention(s)

ESWT (extra-corporeal shock wave therapy): The ESWT device (Storz Medical Duolith SD1),

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change from baseline in patient reported outcomes of spasticity on Numerical Rating Scale (NRS) for Spasticity at weeks 4, 12 and 24. — 4, 12 and 24 weeks from the baseline
  The primary patient reported outcome will be the Numerical Rating Scale (NRS) for Spasticity This is a 0-10 scale where the patients rate their spasticity over a 24hr period. Spasticity in this context is defined to the patients as the experience of muscle stiffness at the target joint over this specified period of time. (farrar et al). The NRS when used in spasticity has been shown to be valid and reliable by farrar et al 2008. It was also shown to correlate with objective scores such as the Modified Ashworth and Tardieu Scales for directly assessing spasticity at a given joint. This study also confirmed that the NRS for Spasticity is a reliable and valid tool in the assessment of spasticity. (Anwar and Barnes, 2009).
• Change from baseline in clinical passive range of motion at the elbow joint treated side with goniometer at weeks 4, 12 and 24. — 4, 12 and 24 weeks from the baseline
  The primary clinical outcome will be the passive range of motion available at the elbow on treated side with a goniometer. It is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. These measurements help accurately track progress in a rehabilitation program. At the elbow, the axis location will be on lateral epicondyle, the stationary arm parallel with the humerus and the movement arm of the goniometer parallel with the radius. Usually, the normal Range of motion at the elbow is around 150 degrees

Trial sites (1)

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