Abstract
BackgroundThere 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.MethodsThis 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.ResultsThere 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).ConclusionsTreatment 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 registrationThe trial was registered at clinical trials.gov (Registry number NCT01760577).
Highlights
There was an increasing requirement for novel treatments of osteoarthritis (OA)
All patients fulfilled the following inclusion criteria: (1) an age of 20–85 years; (2) unilateral ankle pain that had lasted for at least 6 months, with no significant benefit from conservative treatment or with an inability to tolerate the side effects of medications; (3) ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence grading system [17]; (4) a current total Ankle Osteoarthritis Scale (AOS) score of of >3 and ≤ 9 [18]; (5) a normal activity level—i.e., not bedridden or confined to a wheelchair, and able to walk 30 meters without the aid of a walker, crutches or cane; and (6) no changes in shoes or orthotic devices during the study period
Among the 75 patients who were originally in the study, ankle OA was attributed to primary OA in 21 patients
Summary
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. Ankle osteoarthritis (OA) can cause substantial pain and functional limitations. Symptomatic ankle OA is found in less than 1% of the adult population and recent research has indicated patients are being diagnosed with ankle OA with increasing frequency [1,2]. Long-term effective and safe alternative treatments that may reduce pain and improve function yet avoid the toxic effects of medications should be fully exploited. The potential treatment options include intraarticular injection of Botulinum toxin type A (BoNT-A) and hyaluronate injection plus rehabilitation exercise
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
