Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex. The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity. Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015). In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016). However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS). Interestingly, spasticity is a major concern for the rehabilitation of these patients. The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.
Study Type
OBSERVATIONAL
Enrollment
70
Adult patients with spasticity due to traumatic brain injury, spinal cord injury, or MS, treated with Botulinum Toxin type A. As this is a non-interventional study, no diagnostic, therapeutic, or experimental intervention is involved. Subjects will receive clinical assessments, medications, and treatments solely as determined by their study physician.
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
RECRUITINGModified Ashworth Scale (MAS)
Percentage of patients with at least 1 point reduction of MAS in any treated muscle, 1 month after BoNT-A injection injection of Botulinum toxin A (responders)
Time frame: 1 month
Global Assessment of Efficacy scale)
Evaluation of treatment goal achievement by the physicians, patients and caregivers at 1 and 3 months after BoNT-A injection
Time frame: 1 month and 3 months after boNT-A injection
active range of motion
Documentation of active range of motion (a-ROM) for the treated joints in the overall study population at baseline, 1, 3 and 6 months or before new BoNT-A injection using a handheld goniometer.
Time frame: e, 1, 3 and 6 months or before new BoNT-A injection
passive range of motion
Documentation of passive range of motion (p-ROM) for the treated joints in the overall study population at baseline, 1, 3 and 6 months or before new BoNT-A injection using a handheld goniometer.
Time frame: e, 1, 3 and 6 months or before new BoNT-A injection
Numeric Rating Scale for pain
Pain will be assessed in the overall study population at baseline, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection using Numeric Rating Scale (pain).
Time frame: , 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
EQ5-D
Quality of life will be assessed in the overall study population at baseline, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection using EQ5-D questionnaire.
Time frame: 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
interval of time between BoNT-A reinjections
Documentation of the interval of time between reinjections will be assessed during 6-months follow up (if applicable)
Time frame: 3-6 months
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