Clinical trials of at least 10 participants that evaluated treatments for upper limb spasticity secondary to stroke in adults were eligible for inclusion. Studies of treatment for both lower and/or upper limb spasticity were included if the results for patients with upper limb spasticity were reported separately. Case reports, case series, cost-effectiveness analyses, meta-analyses, pooled analyses, systematic reviews, commentaries, editorials and abstracts were excluded. Also excluded were studies that involved lower extremity spasticity only, used botulinum toxin (BTX) formulations not commercially available in USA, focused on treatments for spasticity secondary to diseases other than stroke or included a majority of patients whose spasticity was not secondary to stroke.
The included trials primarily studied BTX (onabotulinumtoxinA, abobotulinumtoxinA and rimabotulinumtoxinB). Some studies also considered tizanidine (TZD) or intrathecal baclofen (ITB). Controls were primarily placebo; some studies used an active comparator such as triamcinolone acetonide or TZD. The reported outcomes included muscle tone and/or spasticity as assessed using the Modified Ashworth Scale or the Ashworth Scale and disability, range of motion, pain, quality of life, adverse events and other clinical outcomes.
One reviewer performed study selection. Any uncertainties were resolved by consensus of the review team.