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Spasticity, defined as a velocity dependent increase of tonic stretch reflexes (muscle tone) with exaggerated tendon jerks can be painful, interfere with functional recovery and hinder rehabilitation efforts. If not managed appropriately, stroke survivors may experience a loss of range of motion at involved joints of the arms, which can result in contracture. Although it is a common in clinical practice to use range-of-motion or stretching exercises and splints to prevent or treat spasticity or contracture following stroke, there is a lack of evidence supporting their benefit.
Turton & Britton (2005) randomized 13 participants with no hand function, admitted to a stroke rehabilitation unit, within 4 weeks of stroke to a program of twice daily stretches for wrist and finger flexors and shoulder adductors and internal rotators, for up to 12 weeks post stroke. By the end of follow-up, patients in both groups had lost an average of 30 degrees of wrist extension and shoulder external rotation ROM of the affected side, but the difference between groups was not significant. Compliance with treatment was poor. Horsley et al. (2007) recruited 40 patients admitted to a rehabilitation service (19 with stroke). All patients received routine upper-limb retraining five days a week. In addition, the experimental group (n=20) received 30 minutes daily stretch of the wrist and finger flexors five days a week for four weeks. There was no difference in the development of contracture, the primary outcome, five weeks after treatment. There were also no differences in pain at rest measured on a 10-cm visual analogue scale, or upper-limb activity measured using the Motor Assessment Scale.
Splints have been widely-used in clinical practice with the aim of the prevention of contractures and reducing spasticity; however, evidence of their effectiveness is lacking. The results from 3 small RCTs suggest that splinting is not effective (Harvey et al. 2006, Lanin et al. 2007, and Basaran et al. 2012). Most recently, Basaran et al. (2012) randomized 39 participants to participate in a 5 week, home-based exercise program in which patients were advised to stretch wrist and finger flexors for 10 repetitions and to try reaching and grasping an object for 10 repetitions 3x/day, in addition to conventional therapy. Patients in the 2 experimental groups wore either a volar or dorsal splint for up to 10 hours overnight throughout the study period, while patients in the control group wore no splint. At the end of the study period, there were no significant differences among groups in terms of reductions in spasticity or wrist passive range of motion. Furthermore, Doucet et al. (2013) evaluated 6 participants, on average, 67.92 months post stroke using a pre-post design. Custom-fitted dynamic progressive wrist extension orthotic was worn for 4 hours daily, 4 times a week for 12 weeks. Modified Ashworth Scale (MAS) scores of the wrist were assessed at baseline and 12 weeks. Half of the sample demonstrated improvement in MAS scores. Andringa et al. (2013) conducted a pre-post study among 6 participants, on average 64 months (range: 22-110) post stroke. Custom-made dynamic orthotics was worn 8 hours daily, for 6 months. MAS scores of the elbow, wrist and fingers were assessed at baseline, 3 months and 6 months. There were no significant differences within or among groups on MAS.
While it is well-established that treatment with Botulinum toxin–type A (BTX-A) reduces focal spasticity in the finger, wrist and elbow, it remains uncertain whether there is also improvement in upper-limb function. In 2 recent, large placebo-controlled RCTs, one which recruited participants within the first month (Shaw et al. 2012) and the other an average of 6 years following stroke (McCrory et al. 2009), significant reductions in spasticity, assessed using the Modified Ashworth Scale scores were reported in both studies. Shaw et al. (2012) reported there was no significant difference in the percentage of patients who had achieved a successful outcome (defined by 3 different levels of improvement on the Action Research Arm Test, depending on baseline arm function) at one month following treatment: 25% of patients in the treatment group compared with 19.5% of patients in the control group (p=0.232). However, significant differences in favor of the intervention group were seen in muscle tone at 1 month; upper limb strength at 3 months; basic arm functional tasks (hand hygiene, facilitation of dressing) at 1, 3, and 12 months, and pain at 12 months. McCrory et al. (2009) reported there were no significant between group differences in Assessment of Quality of Life scale change scores, pain, mood, disability or carer burden at 20 weeks. Coban et al. (2014) reported results from a pre-post study of 17 patients with upper limb spasticity at least 1 year post-stroke. Two preparations of Botox and Dysport were used. Injections were administered in one distal part of the upper limb (the upper limb spasticity group, 15 patients) or lower limb (the lower limb spasticity group, 12 patients). MAS of elbow flexors, forearm pronators, wrist flexors and finger flexors were assessed after the first, second, and fifth injection. Only forearm pronators showed a statistically significant change in MAS scores between the first versus second injection (p=0.021) and first versus fifth injection (p=0.021). An RCT evaluating 18 participants with upper limb spasticity (MAS=1-2) who were 4-6 months post stroke was conducted (Hesse et al. 2012). Participants were randomized into two groups: 1) 150 U BTX-A injected into the deep and superficial finger (100 U) and wrist flexors (50 U), or 2) no injection. MAS of fingers were assessed at baseline, 4 weeks and 6 months. Individuals in the treatment group experienced significantly less finger flexor stiffness at 4 weeks (p<0.001) and 6 months (p=0.025) (Hesse et al. 2012).
Santamoto et al. (2013) conducted a pre-post of 25 patients with upper limb spasticity (AS ≥2) who were ≥ 6 months post stroke. Participants received one set of injections of BTX-A, in their hypertonic upper and lower limb; maximum total dosage in the upper limbs was 840 U (range 750-840 U). Disability Assessment Scale (DAS) was assessed 30- and 90-days post injections. Mean DAS scores decreased at 30 and 90 days after treatment (p<0.05). However, the rate of response was higher for investigators than patients; 40% of investigators and 28% of patients rated their clinical picture as “marked improvement.” Takekawa et al. (2013) studied participants with upper limb spasticity 64.8 months post stroke. BTX-A was injected into the elbow flexors, wrist flexors, forearm pronators or finger flexors with a total dosage less than 240 U. After the injection, participants participated in one-on-one home-based functional training for 15 minutes with an occupational therapist. MAS of elbow flexors, wrist flexors, forearm pronators and finger flexors were assessed at baseline, and at 1-, 3- and 6-month follow-up. A significant reduction in MAS scores were noted in all muscles examined, at 1-, 3-, and 6-month follow-up compared to baseline (p<0.001 for all).
In cases where spasticity is generalized, and it would be impractical, or contrary to patients’ wishes to inject multiple muscle groups with BTX-A, the use of oral agents may be considered as an alternative treatment. Traditional pharmacotherapies for spasticity include centrally acting depressants (baclofen and tizanidine) and muscle relaxants; (dantrolene) however; these treatments are only partially effective in treating spasticity and have the negative side effects of weakness and sedation. Treatment with oral baclofen has not been studied in the stroke population and is used more frequently in patients recovering from spinal cord injury. Tizanidine has been well-studied in other conditions including multiple sclerosis and acquired brain injury, and has a better side effect profile than other oral agents. There is only a single open-label trial of the use of tizanidine post stroke (Gelber et al. 2001). Following 16 weeks of treatment in which 47 patients received a maximum daily dose of 36 mg (mean 20 mg), there was a decrease in mean combined total modified Ashworth Scale scores (9.3 vs. 6.5, p=0.038). There were also significant improvements in pain, quality of life, and physician assessment of disability.