Early physiotherapy after injection of botulinum toxin increases the beneficial effects on spasticity in patients with multiple sclerosis
ABSTRACT To determine whether additional physiotherapy increases botulinum toxin type A effects in reducing spasticity in patients with multiple sclerosis.
A single-blind, randomized, controlled pilot trial with a 12-week study period.
Thirty-eight patients with progressive multiple sclerosis affected by focal spasticity and who were observed at the Multiple Sclerosis Centre operating in the S. Andrea Hospital in Rome.
For intervention all patients received botulinum toxin type A; the treatment group also received additional physiotherapy to optimize management through passive or active exercise and stretching regimens.
To measure objective and subjective level of spasticity, patients were assessed at baseline, 2, 4 and 12 weeks post treatment by Modified Ashworth Scale and visual analogue scale.
When compared with the control group, we found a significant decrease of spasticity by Modified Ashworth Scale (P < 0.01 by t-test) in the treatment group at week 2 (2.73 versus 3.22), week 4 (2.64 versus 3.33) and week 12 (2.68 versus 3.33). The mean (%) difference in Modified Ashworth Scale score between baseline and the end of follow-up was -0.95 (26.1) in the treatment group and -0.28 (7.7) in the control group (P < 0.01). The combined treatment proved also to be more effective by visual analogue scale (P < 0.01) at week 4 (6.95 versus 5.50) and at week 12 (7.86 versus 6.56) but not at week 2 (5.18 versus 5.50; P = 0.41).
Our data suggest that physiotherapy in combination with botulinum toxin type A injection can improve overall response to botulinum toxin.
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ABSTRACT: Evaluate safety and efficacy of Incobotulinumtoxin A in elderly patients with dementia and paratonia. University-affiliated hospital, spasticity management Clinic. Ten subjects were enrolled. 1) severe cognitive impairment 2) diagnosis of Alzheimer's disease, vascular dementia, or frontotemporal dementia, and 3) score >3 on the paratonic assessment instrument, with posture in an arm(s) interfering with provision of care. 1) alternate etiologies for increased tone and 2) injection with botulinum toxin within the 6 months preceding the study. Single center, randomized, double blind, placebo-controlled, crossover trial with two treatment cycles of 16 weeks. Assessments occurred at 2, 6, 12 and16 weeks following injections. Subjects received up to 300 U of Incobotulinumtoxin A in arm(s). Primary outcome measure was the modified caregiver burden scale (mCBS); exploratory secondary outcome measures were also performed. Analysis of variance and mixed modeling techniques were used to evaluate treatment effects. Incobotulinumtoxin A treatment produced significant improvement in mCBS total score -1.11 (-2.04 to -0.18) (Treatment effect and 95% CI), dressing sub-score -0.36 (-0.59 to 0.12), and cleaning under the left and right armpits sub-score -0.5 (-0.96 to -0.04), -0.41 (-0.79 to -0.04) respectively. PROM in the left and right elbow increased by 27.67 degrees (13.32-42.02) and 22.07 degrees (9.76-34.39) respectively. PROM in the left and right shoulder increased by 11.92 degrees (5.46-18.38) and 8.58 degrees (3.73-13.43) respectively. No significant treatment effect was found for GAS, VAS and PAINAD scales or change in time to perform care. No adverse drug reactions occurred. Administration of Incobotulinumtoxin A in elderly people with advanced dementia and paratonia may be an efficacious and safe treatment to increase range of motion and reduce functional burden. Further studies are needed to confirm results. ClinicalTrials.Gov NCT02212119.PLoS ONE 12/2014; 9(12):e114733. DOI:10.1371/journal.pone.0114733 · 3.53 Impact Factor
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ABSTRACT: Objective: Although calf muscle spasticity is often treated with botulinum toxin type-A, the effects on balance and gait are ambiguous. Hereditary spastic paraplegia is characterized by progressive spasticity and relatively mild muscle weakness of the lower limbs. It is therefore a good model to evaluate the functional effects of botulinum toxin type-A. Design: Explorative pre-post intervention study. Subjects: Fifteen subjects with pure hereditary spastic paraplegia. Methods: Patients with symptomatic calf muscle spasticity and preserved calf muscle strength received botulinum toxin type-A injections in each triceps surae (Dysport®, 500-750 MU) followed by daily stretching exercises (18 weeks). Before intervention (T0), and 4 (T1) and 18 (T2) weeks thereafter, gait, balance, motor selectivity, calf muscle tone and strength were tested. Results: Mean comfortable gait velocity increased from T0 (0.90 m/s (standard deviation (SD) 0.18)) to T1 (0.98 m/s (SD 0.20)), which effect persisted at T2, whereas balance and other functional measures remained unchanged. Calf muscle tone declined from T0 (median 2; range 1-2) to T1 (median 0; range 0-1), which effect partially persisted at T2 (median 1; range 0-2). Calf muscle strength did not change. Conclusion: Botulinum toxin type-A treatment and subsequent muscle stretching of the calves improved comfortable gait velocity and reduced muscle tone in patients with hereditary spastic paraplegia, while preserving muscle strength. Balance remained unaffected.Journal of Rehabilitation Medicine 10/2014; 47(2). DOI:10.2340/16501977-1909 · 1.90 Impact Factor
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ABSTRACT: Objective: To examine the benefits of high intensity ambulatory rehabilitation programs over usual care following botulinum toxin A (BoNT-A) for post-stroke spasticity in Australian adults. Design: Prospective single centre, controlled clinical trial. Participants: Fifty-nine adults, median 61 years old and 2.5 years following stroke. Methods: Participants were dichotomised into high intensity ambulatory rehabilitation programs (≥ 3 × 1-h weekly sessions for approximately 10 weeks) or usual care programs (≤ 2 × 1-h weekly sessions) following BoNT-A injections for spasticity. A blinded assessor completed outcomes at 0 (baseline), 6, 12 and 24 weeks. Primary endpoints: proportion of participants achieving ≥ 50% of their goals (using Goal Attainment Scaling: GAS) and GAS T-score change at 12 weeks. Secondary outcomes: Modified Ashworth Scale (MAS), participant satisfaction, activity/participation measures and caregiver burden. Results: Both groups showed significant improvement in goal attainment and participant satisfaction up to 24 weeks, with no overall between-group significant differences. There was, however, a statistical trend (p = 0.052) for participants to achieve more upper limb goals in the high intensity therapy group. GAS and satisfaction benefits persisted beyond the duration of spasticity reduction as measured by MAS. Conclusions: While patient-centred outcomes following BoNT-A injections for post-stroke spasticity were not influenced by intensity of ambulatory rehabilitation programs, there was a trend for high intensity therapy to be associated with greater upper limb goal attainment. This suggests that the effects of more intensive therapy may be a modifier of the 'black box' of rehabilitation; however, further research is required to evaluate this effect and determine which elements of therapy programs optimise post-BoNT-A outcomes.Journal of Rehabilitation Medicine 07/2014; 46(8). DOI:10.2340/16501977-1842 · 1.90 Impact Factor