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.
Acquired brain injury (of at least 1 year following the event);
Stroke;
Cerebral Palsy (CP);
Male and females over 18 years of age.
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;
Parallel
ESWT (extra-corporeal shock wave therapy)
DeviceThe ESWT device (Storz Medical Duolith SD1),
Sham : The ESWT device (Storz Medical Duolith SD1),
DeviceIn 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.
Change from baseline in patient reported outcomes of spasticity on Numerical Rating Scale (NRS) for Spasticity at weeks 4, 12 and 24.
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.
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
Change from baseline of patient reported outcomes quality of life on EQ-5D-5L questionnaire at weeks 4, 12 and 24.
The secondary patient reported outcome will be the EQ-5D-5L. It is a validated five dimensional quality of life questionnaire recording variance using a five points scale to determine the participant's self-perception of mobility, self-care, usual activities, pain/discomfort, anxiety/depression
Change from baseline on spasticity level on Modified Ashworth Scale (MAS) at 4, 12 and 24 weeks
The secondary clinical outcomes variables will be the Modified Ashworth Scale (MAS) provides a simple, validated and easily replicable method of assessing objectively the participants level of spasticity in the target joint. This will be compared with the NRS to support correlation between the subjective and objective nature of the two assessment tools.
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.
Feasibility of the project will be mainly determine by the adherence to the protocol. To measure it we will use: 1. Percentage of number of participants without any missing data at the end of the study (all measurements and questionnaires have be done and recorded). 2. Percentage of number of participants who drop-out of the study at the end of the study.
Measure the acceptability of the procedure (ESWT) throughout the study using a pain numerical rating scale (NRS).
Acceptability of the procedure, defined as the extent to which participants considered ESWT reasonable and appropriate in terms of their experience. We will use : measured as self-reported symptoms of pain during each of the assessments using a numerical rating scale ranging from 0 \[no discomfort\] to 10 \[worst pain imaginable\]
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