A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients.

Abstract

Objective-To confirm the apparent effectiveness of botulinum toxin (BTX) in hemiparetic patients with ankle plantar flexor and foot invertor spasticity. Methods-Twenty three hemiparetic patients with spasticity of the ankle plantar flexors and foot invertors were included in a randomised double blind, placebo controlled study with BTX. Patients were examined on days 0, 30, 90, and 120 and received one injection of BTX and one of placebo in a random order at day 0 and day 90. Results-Patients reported a clear subjective improvement in foot spasticity after BTX (P = 0-0014) but not after placebo. Significant changes were noted in Ashworth scale values for ankle extensors (P < 0.0001) and invertors (P = 0.0002), and for active ankle dorsiflexion (P = 0-0001). Gait velocity was slightly but not significantly (P = 0-0731) improved after BTX injections. The severity of spasticity did not modify treatment efficacy, but BTX was less effective in patients with longer duration of spasticity (P = 0-0081). Conclusion-The efficacy of BTX injections in the treatment of spastic foot suggests that BTX may be particularly useful during the first year after a stroke.

Botulinum neurotoxins for post‐stroke spasticity in adults: A systematic review

“…A similar evaluation was not performed for the lower limb, as only one study on the lower limb spasticity could be included based on our strict criteria 27 ; the other available trials were excluded because the patients were also treated with casts, 17 or they did not all have post-stroke spasticity, 18 or the data were incomplete. 19 The results of the lower limb spasticity study included showed no significant improvement in walking or spasticity 27 following injection in the gastrocnemius muscle. This evidence is very limited, because several other muscles (including the tibialis anterior and posterior, flexor and extensor digitorum or the peroneal muscles) are involved in post-stroke lower limb spasticity.…”

“…Five studies were excluded because participants were treated with phenol block 15,16 or casts, 17 because not all patients had post-stroke spasticity, 18 or because the data were incomplete. 19 Two trials were reported both as full length publication and as abstract. 10,[20][21][22] Thence, the review assessed eleven randomized, placebo-controlled, double-blind trials (Table 1) involving a total of 782 patients.…”

Botulinum toxin in the management of spasticity in adults

“…Most of the research has been conducted in stroke. Double-blinded placebo-controlled trials have shown it to be safe and effective in the management of spasticity in both the upper limb 1,2 and the lower limb 3,4 . Studies in multiple sclerosis 5,6 have demonstrated functional benefits in the management of hip adductor spasticity.…”

Evaluation of Muscle Tension in Hemiplegia Patients with a Real-time Monitoring System during High Intensity Laser Therapy

“…We found that the treatment efficacy decreased exponentially as a function of the duration of illness. Some studies have reported a similar drop in efficacy as a function with the duration of the illness [30][31][32][33]. Recovery of muscle function has been shown to be the most significant during the first week after stroke, and rehabilitation is less effective when initiated more than 3 months after a stroke [30].…”

“…Recovery of muscle function has been shown to be the most significant during the first week after stroke, and rehabilitation is less effective when initiated more than 3 months after a stroke [30]. It has also been reported that the most significant factor affecting treatment efficacy is not the severity of the muscle tension, rather the duration of the illness [31][32][33]. Moreover, the ceiling effect; i.e., an increasing dose of a given medication or treatment having progressively smaller effect, may affect the efficacy of treatment [34][35][36][37].…”