Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Ankle Osteoarthritis

Treatments: Drug: Hyalgan (Hyalgan, Fidia , Italy); Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01760577

VGHKS100-061

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

The Botulinum Toxin A group

Experimental group

Description:

The Botulinum Toxin A group received intraarticular injections of 100 units of Botulinum Toxin A (Allergan, Inc, Irvine CA) reconstituted in 2 cc normal saline.

Treatment:

Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)

The hyaluronate group (Hyalgan, Italy)

Active Comparator group

Description:

The hyaluronate group received intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, molecular weight 500-730kDa, Fidia Pharmaceutical Corporation, Abano Terme, Italy) and subsequent 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise for 2 weeks .

Treatment:

Drug: Hyalgan (Hyalgan, Fidia , Italy)