Intrathecal baclofen for intractable cerebral spasticity: A prospective placebo-controlled, double-blind study

OBJECTIVE: To conduct a placebo-controlled prospective study of the effecti veness of intrathecal bolus injections and continuous administration of bac lofen on functional parameters in patients with severe spasticity of cerebr al origin. To compare this functional evaluation with spasticity scores in different muscle groups. METHODS: In 11 patients with spasticity of cerebral origin (mainly cerebral palsy), double-blind scoring of spasticity (Ashworth scale score and visua l analog score), spasms, pain, and functional abilities was performed durin g tests with bolus injections including a placebo control. Eight patients w ere considered good responders and received a subcutaneous device for intra thecal drug delivery. Six of these patients were followed up for 2 years, d uring which they underwent the same scoring procedures as after their bolus injections. These patients were subjected to a blinded dose reduction test . RESULTS: There was a noticeable placebo effect on spasticity scores during tests with bolus injections. Eight patients demonstrated a significant bene ficial effect of intrathecal bolus injections compared with this placebo ef fect, Functional improvements were noted in most patients. During continuou s infusion, Ashworth scale scores were less favorable but still significant ly lower than at baseline. Subjective evaluation (visual analog scores) rem ained positive, functional improvements were maintained, and patient comfor t was invariably and significantly improved. CONCLUSION: Intrathecal administration of baclofen is a safe and effective treatment for spasticity of cerebral origin. Functional improvement was dem onstrated. The presence of a placebo effect on the spasticity scores sugges ts the need for double-blind screening in each patient.