Efficacy of intraarticular botulinum toxin A and intraarticular hyaluronate plus rehabilitation exercise in patients with unilateral ankle osteoarthritis: a randomized controlled trial.

Background: There was an increasing requirement for novel treatments of osteoarthritis (OA). The aim was to compare the efficacy of intraarticular Botulinum toxin type A (BoNT-A) and intraarticular hyaluronate plus rehabilitation exercise in patients with ankle OA.
Methods: This was a prospective, randomized, assessor-blinded study with a 6-month follow-up period, conducted in the outpatient rehabilitation department at a university-affiliated tertiary care medical center. Seventy-five patients with symptomatic ankle OA (Kellgren-Lawrence grade 2) were randomized to receive either a single 100-unit BoNT-A injection into the target ankle (n = 38) or a single hyaluronate injection plus 12 sessions of rehabilitation exercise (30 minutes/day, 3 times/week for 4 weeks) (n = 37). The primary outcome measure was the Ankle Osteoarthritis Scale (AOS). Secondary outcome measures included American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score, visual analog scale (VAS) for ankle pain, single leg stance test (SLS), Timed "Up-and-Go" test (TUG), consumption of rescue analgesics and global patient satisfaction.
Results: There were no significant between-group differences in total AOS scores, pain subscale and disability subscale scores (adjusted mean difference AMD = -0.2, 95% CI = (-0.5, 0.2), p = 0.39; AMD = -0.1, 95% CI = (-0.5, 0.3), p = 0.57; AMD = -0.2, 95% CI = (-0.6, 0.2), p = 0.36). The 2 groups showed no significant differences in AOFAS, VAS, SLS, TUG scores and consumption of rescue analgesics at each follow-up visit, except that the hyaluronate group improved more in SLS than the BoNT-A group at 1-month follow-up. Patients' satisfaction rate was high, with no serious adverse events. There was no difference in adverse events between the two groups (p = 1.00).
Conclusions: Treatment with intraarticular BoNT-A or hyaluronate injection plus rehabilitation exercise was associated with improvements in pain, physical function and balance in patients with ankle OA. These effects were rapid at 2 weeks and might last for at least 6 months. There was no difference in effectiveness between the two interventions.
Trial Registration: The trial was registered at clinical trials.gov (Registry number NCT01760577).