NCT01760577

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Ankle Osteoarthritis

Interventions

Type	Name	Description
DRUG	Botulinum Toxin A (Allergan, Inc, Irvine CA)	patients received intraarticular injections by the same experienced physician using aseptic procedures.
DRUG	Hyalgan (Hyalgan, Fidia , Italy)	The rehabilitation program consists of 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise program for another 2 weeks.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-05-01
• Completion: 2012-11-01
• First posted: 2013-01-04
• Last updated: 2013-01-04

Locations

1 site across 1 country: Taiwan