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Intrathecal baclofen for intractable cerebral spasticity: a prospective placebo-controlled, double-blind study.
Neurosurgery. 2000 Mar; 46(3):603-9; discussion 609-12.N

Abstract

OBJECTIVE

To conduct a placebo-controlled prospective study of the effectiveness of intrathecal bolus injections and continuous administration of baclofen on functional parameters in patients with severe spasticity of cerebral 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 visual analog score), spasms, pain, and functional abilities was performed during tests with bolus injections including a placebo control. Eight patients were considered good responders and received a subcutaneous device for intrathecal drug delivery. Six of these patients were followed up for 2 years, during 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 beneficial effect of intrathecal bolus injections compared with this placebo effect. Functional improvements were noted in most patients. During continuous infusion, Ashworth scale scores were less favorable but still significantly lower than at baseline. Subjective evaluation (visual analog scores) remained positive, functional improvements were maintained, and patient comfort was invariably and significantly improved.

CONCLUSION

Intrathecal administration of baclofen is a safe and effective treatment for spasticity of cerebral origin. Functional improvement was demonstrated. The presence of a placebo effect on the spasticity scores suggests the need for double-blind screening in each patient.

Authors+Show Affiliations

Department of Neurosurgery, University Hospital Gasthuisberg, Leuven, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

10719857

Citation

Van Schaeybroeck, P, et al. "Intrathecal Baclofen for Intractable Cerebral Spasticity: a Prospective Placebo-controlled, Double-blind Study." Neurosurgery, vol. 46, no. 3, 2000, pp. 603-9; discussion 609-12.
Van Schaeybroeck P, Nuttin B, Lagae L, et al. Intrathecal baclofen for intractable cerebral spasticity: a prospective placebo-controlled, double-blind study. Neurosurgery. 2000;46(3):603-9; discussion 609-12.
Van Schaeybroeck, P., Nuttin, B., Lagae, L., Schrijvers, E., Borghgraef, C., & Feys, P. (2000). Intrathecal baclofen for intractable cerebral spasticity: a prospective placebo-controlled, double-blind study. Neurosurgery, 46(3), 603-9; discussion 609-12.
Van Schaeybroeck P, et al. Intrathecal Baclofen for Intractable Cerebral Spasticity: a Prospective Placebo-controlled, Double-blind Study. Neurosurgery. 2000;46(3):603-9; discussion 609-12. PubMed PMID: 10719857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intrathecal baclofen for intractable cerebral spasticity: a prospective placebo-controlled, double-blind study. AU - Van Schaeybroeck,P, AU - Nuttin,B, AU - Lagae,L, AU - Schrijvers,E, AU - Borghgraef,C, AU - Feys,P, PY - 2000/3/17/pubmed PY - 2000/4/29/medline PY - 2000/3/17/entrez SP - 603-9; discussion 609-12 JF - Neurosurgery JO - Neurosurgery VL - 46 IS - 3 N2 - OBJECTIVE: To conduct a placebo-controlled prospective study of the effectiveness of intrathecal bolus injections and continuous administration of baclofen on functional parameters in patients with severe spasticity of cerebral 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 visual analog score), spasms, pain, and functional abilities was performed during tests with bolus injections including a placebo control. Eight patients were considered good responders and received a subcutaneous device for intrathecal drug delivery. Six of these patients were followed up for 2 years, during 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 beneficial effect of intrathecal bolus injections compared with this placebo effect. Functional improvements were noted in most patients. During continuous infusion, Ashworth scale scores were less favorable but still significantly lower than at baseline. Subjective evaluation (visual analog scores) remained positive, functional improvements were maintained, and patient comfort was invariably and significantly improved. CONCLUSION: Intrathecal administration of baclofen is a safe and effective treatment for spasticity of cerebral origin. Functional improvement was demonstrated. The presence of a placebo effect on the spasticity scores suggests the need for double-blind screening in each patient. SN - 0148-396X UR - https://www.unboundmedicine.com/medline/citation/10719857/Intrathecal_baclofen_for_intractable_cerebral_spasticity:_a_prospective_placebo_controlled_double_blind_study_ L2 - https://academic.oup.com/neurosurgery/article-lookup/doi/10.1097/00006123-200003000-00017 DB - PRIME DP - Unbound Medicine ER -