Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis

The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.

Recent pilot studies report that intraarticular injection of Botulinum Toxin A into painful joints of patients with various types of arthritis leads to significant and durable improvement in pain and function and is safe to use. To date, there is no published literature that evaluate the effects of intraarticular Botulinum Toxin A in the treatment of ankle OA. Sun el al reported that 3 or 5 weekly injection of hyaluronate may improve pain and physical function in patients with ankle OA and the treatment effects may last for 6 months. The effect of one injection of hyaluronate plus exercise had never been studied. The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise for patients with ankle OA.

Inclusion Criteria:

• an age of 20-85 years with diagnosis of ankle osteoarthritis
• 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
• ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence grading system
• a current total Ankle Osteoarthritis Scale (AOS) score of >3 and < 9 (possible range, 0-10)
• a normal activity level-i.e., not bedridden or confined to a wheelchair, and are able to walk 30 meters without the aid of a walker, crutches or cane
• no changes in shoes or orthotic devices during the study period.

Exclusion Criteria:

• pregnancy or lactation in women
• lower leg trauma other than ankle trauma
• previous surgery involving the spine, hip or knee
• the presence of an active joint infections of foot or ankle
• previous surgery or arthroscopy on the ankle within 12 months
• history of chicken or egg allergy
• intraarticular steroid or hyaluronate injection in the treated ankle within the previous 6 months
• treatment with anticoagulants or immunosuppressives
• a history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
• the presence of other comorbidity (such as neoplasms, diabetes mellitus, paresis or recent trauma) or poor health status that would interfere with the clinical assessments during the study.