Botulinum toxin A (BoNT-A, Botox) treatment prior to intensive physiotherapy may not induce additional benefits in terms of motor function, muscle strength, and pain in children with spastic cerebral palsy compared to physiotherapy alone, according to a Dutch study.
The study, “Intramuscular botulinum toxin prior to comprehensive rehabilitation has no added value for improving motor impairments, gait kinematics and goal attainment in walking children with spastic cerebral palsy,” was published in the Journal of Rehabilitation Medicine.
BoNT-A injections directly into the muscle have been widely used in combination with post activity-focused interventions such as intensive physiotherapy, and if necessary, casting or ankle-foot orthoses (plastic supports intended to maintain proper foot alignment) in ambulatory children with spastic cerebral palsy. This is the most common form of cerebral palsy that affects muscle control movement, mainly in the arms and legs.
Because BoNT-A injections reduce spasms, they are believed to improve the activity of children and reinforce the effects of these interventions.
This combined approach has been shown to be more effective than low-intensity standard care and to improve patients’ motor function, walking ability, self-care independence, and cerebral palsy-related pain.
But the real benefits of adding BoNT-A injections before activity-focused interventions remain poorly studied.
In addition, BoNT-A treatment is costly and burdensome — it involves the injection of a toxin, usually under anesthesia, and repeated treatments — supporting the importance of assessing its added therapeutic value.
A partly-randomized, multi-center study in Europe called SPACE BOP compared the effectiveness of BoNT-A treatment prior to a 12-week high-intensity physiotherapy program to the physiotherapy program alone in ambulatory children with spastic cerebral palsy.
Sixty-five children, ages 4-12, were enrolled between October 2009 and September 2013 in the Netherlands. Forty-one received the combination treatment, while 24 received only intensive physiotherapy. Casting or ankle-foot orthoses were also applied when necessary.
Previous results from the SPACE BOP study had shown that adding BoNT-A treatment to intensive physiotherapy did not benefit motor function, level of physical activity, and health-related quality of life compared to physiotherapy alone, after three months of treatment and at follow-up (an additional three months).
The combination approach was also more costly — $11,000 U.S vs. $7,590 for physiotherapy alone.
Researchers now evaluated the added value of providing botulinum toxin treatment prior to a period of comprehensive rehabilitation in terms of leg muscle strength and spasticity, walking ability, cerebral palsy-related pain, the degree to which individual therapy goals were achieved, and parent-reported general function, compared to intensive physiotherapy alone.
While both treatments showed a trend toward improvement in all evaluated parameters, both at the end of treatment and at follow-up, the combination therapy did not induce any additional statistically significant benefits.
The only parameter statistically different between patients in each group was the angle at which a catch sensation developed during the fast stretch of the rectus femoris — a leg muscle — which was, in fact, in favor of physiotherapy alone.
According to the researchers, the results suggest the need to seriously reconsider the “widespread prescription and use of botulinum toxin for spastic cerebral palsy in this age and severity subgroup.”