Objective: To review the available evidence on the effectiveness of intrathecal baclofen in the treatment of spasticity in individuals with spinal cord injuries (SCIs) at least 6 months post-injury or diagnosis.
Data sources: A literature search of multiple databases (Pub Med, CINAHL, EMBASE) was conducted to identify articles published in the English language.
Study selection: Studies were included for review if: (1) more than 50% of the sample size had suffered a traumatic or non-traumatic SCI; (2) there were more than three subjects; (3) subjects received continuous intrathecal baclofen via an implantable pump aimed at improving spasticity; and (4) all subjects were ≥6 months post-SCI, at the time of the intervention.
Data extraction: Data extracted from the studies included patient and treatment characteristics, study design, method of assessment, and outcomes of the intervention.
Data synthesis: Methodological quality was assessed using the PEDro for randomized-controlled trials (RCTs) and the Downs and Black (D&B) tool for non-RCTs. A level of evidence was assigned to each intervention using a modified Sackett scale.
Conclusion: The literature search resulted in 677 articles. No RCTs and eight non-RCTs (D&B scores 13-24) met criteria for inclusion, providing a pooled sample size of 162 individuals. There was substantial level 4 evidence that intrathecal baclofen is effective in reducing spasticity. Mean Ashworth scores reduced from 3.1-4.5 at baseline to 1.0-2.0 (P < 0.005) at follow-up (range 2-41 months). Average dosing increased from 57-187 µg/day at baseline to 218.7-535.9 µg/day at follow-up. Several complications from the use of intrathecal baclofen or pump and catheter malfunction were reported.
Keywords: Activities of daily living; Ashworth scale; Baclofen; Muscle spasticity; Spinal cord injuries.