Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

Not Applicable

Completed

• Conditions: Ankle Osteoarthritis
• Interventions: Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA); Drug: Hyalgan (Hyalgan, Fidia , Italy)

• Registration Number: NCT01760577
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief 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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-05
• Study Completion: 2012-11
• Study First Submitted: 2012-12-30
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Botulinum Toxin A group	Botulinum Toxin A (Allergan, Inc, Irvine CA)	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.
The hyaluronate group (Hyalgan, Italy)	Hyalgan (Hyalgan, Fidia , Italy)	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 .

Primary Outcome Measures

Name	Time	Method
Ankle Osteoarthritis Scale (AOS) score	at 6 months after the injection	The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale.Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable

Secondary Outcome Measures

Name	Time	Method
adverse effects	at 2 weeks, 1 month, 3 months, and 6 months post injection.	patients recorded any systemic and local adverse effects (defined as any unwanted effect whether it was thought to be related to the study or not) on a diary card.
AOFAS ankle/hindfoot score	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.	AOFAS ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment.
Visual analog scale (VAS)	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection	The patient rate the intensity of average ankle movement pain in the previous week using a 10-cm horizontal Visual analog scale (VAS)
Single-leg stance test (SLS)	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection	Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with ankle OA and maintain balance for as long as possible
Timed " Up-and-Go" test (TUG)	pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection	A Timed " Up-and-Go" test (TUG) measures functional mobility and the dynamic balance of an individual.
global Patients satisfaction	at 2 weeks, 1 month, 3 months, and 6 months post injection.	This rating is based on a 7-point categorical scale ranging from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road; 🇨🇳 Kaohsiung, Taiwan