Surgery versus botulinum toxin for poststroke upper extremity spasticity: a prospective randomized trial on function, care, and quality of life

Background Over 93 million people worldwide live with stroke sequelae. Surgery is an effective and safe approach to poststroke upper extremity spasticity, which is usually treated by botulinum toxin type A (BoNT-A) injections. Surgery is commonly restricted to the most severe patients, but no clinical trial has compared the outcomes of these procedures. Materials and Methods A randomized, controlled, parallel-group clinical trial with 12-month follow-up was conducted in adults with poststroke upper extremity spasticity and eligibility for surgery, recruited from two third-level hospitals in southern Spain. The objective was to compare functional, hygienic, and pain outcomes and the effects on emotional status, quality of life, and care burden between surgery and BoNT-A. For continuous outcomes, mixed-effects generalized linear models were developed with fixed effects for group, time, and their interaction, adjusted for baseline, with a random intercept for each subject to account for within-patient correlation. For ordinal outcomes, mixed-effects cumulative-link models were used with a complementary log–log link function, adjusted for baseline. Results Significantly greater improvements in Fugl-Mayer and modified Ashworth spasticity scale scores and a significantly higher patient satisfaction rate were obtained in the surgery group ( n = 21) than in the botulinum toxin (BoNT) group ( n = 24). Unlike BoNT-A, surgery significantly reduced the care burden and 36-item Short Form Health Survey (SF-36)-assessed pain of patients. The treatments did not significantly differ in their impact on emotional status or overall quality of life. The postsurgery complication rate was 23.8%, most frequently incomplete deformity correction requiring repeat surgery. Conclusions In comparison to BoNT-A, surgery offers significantly greater spasticity reduction and functional improvement in patients with poststroke upper extremity spasticity, and it significantly decreases the caregiver burden. These findings support a greater role for upper extremity surgeons in a multidisciplinary approach to these patients. Trials with longer follow-ups are warranted to further explore the durability of these outcomes. Level of evidence: I Trial registration: the trial is registered on Clinical Trials.gov with the registration no. NCT06392633. Retrospectively registered on 30 April 2024.