Abstract
Purpose: Ankle osteoarthritis (OA) can cause substantial pain and functional limitations. Effective therapy has been a key therapeutic challenge. The aim of this pilot study is to investigate the effects of intra articular Botulinum toxin type A (BoNT-A) for the treatment of patients with painful ankle OA. Methods: This was a prospective study conducted in a university-affiliated tertiary care medical center with 6- month follow-up. Patients with painful ankle OA for at least 6 months and radio graphically verified as having stage II OA according to the Kellgren-Lawrence classification were enrolled. Eligible patients received single intraarticular injections of BoNT-A (100 units). The primary outcome was the Ankle Osteoarthritis Scale (AOS) score at 6-month follow-up. Secondary outcomes measures included American Orthopaedic 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) and consumption of rescue analgesics. Patients were evaluated at baseline, 2 weeks, 1 month, 3 months, and 6 months post injection. Patients’ global satisfaction about therapy was assessed at 2 weeks, 1 month, 3 months, and 6 months post injection. Adverse events during the study period were recorded also. Results: Thirty-six patients completed the study. All patients showed significant improvements in AOS, AOFAS, VAS, SLS, TUG scores and consumption of rescue analgesics at 2 weeks, 1, 3 and 6 months respectively after the injection (p < 0.001 for each value compared with baseline). Patients’ global satisfaction rate was high with no serious adverse events. Conclusion: BoNT-A injection to the ankle joint is associated with improvement in pain, function and balance in patients with painful ankle OA. These effects can last for 6 months. This pilot study supports a possible role for BoNT-A as a treatment option for painful ankle OA. Future studies are needed to confirm the results.
Highlights
Ankle osteoarthritis (OA) can cause pain and disability
The purpose of this study is to investigate the effects of intra articular Botulinum toxin type A (BoNT-A) for the treatment of patients with painful ankle OA
All patients met the following inclusion criteria:(1) an age of 20-85 years, 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; (2) ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence grading system [8]; (3) a current total Ankle Osteoarthritis Scale (AOS) score of of >3 and < 9; (4) a normal activity leveli.e., not bedridden or confined to a wheelchair, and are able to walk 30 meters without the aid of a walker, crutches or cane; and (5) no physical therapy, shoe changes or orthotic devices used during the study period
Summary
Ankle osteoarthritis (OA) can cause pain and disability. Current treatment options include analgesics, non-steroidal anti-inflammatory medication (NSAIDs), weight loss, physical therapy, exercise, activity modification, assistive devices, local injections, and surgical treatment. The treatment goals are to reduce pain and improve function. Oral analgesics have substantial limitations because they may not provide sufficient joint pain relief and often produce intolerable drug side effects and adverse drug interactions [1,2]. Intra articular therapies with corticosteroids or viscosupplements may reduce pain, but the duration of effect is variable [3]. Effective and safe treatments that may reduce pain and improve function yet avoid the toxic effects of medications should be fully exploited. A potential treatment option for patients may be the intra articular application of Botulinum toxin type A (BoNT-A)
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