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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
patients received intraarticular injections by the same experienced physician using aseptic procedures.
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.
Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road
Kaohsiung City, Taiwan
Ankle Osteoarthritis Scale (AOS) score
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
Time frame: at 6 months after the injection
AOFAS ankle/hindfoot score
AOFAS ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment.
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.
Visual analog scale (VAS)
The patient rate the intensity of average ankle movement pain in the previous week using a 10-cm horizontal Visual analog scale (VAS)
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
Single-leg stance test (SLS)
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
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
Timed " Up-and-Go" test (TUG)
A Timed " Up-and-Go" test (TUG) measures functional mobility and the dynamic balance of an individual.
Time frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
global Patients satisfaction
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.
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Time frame: at 2 weeks, 1 month, 3 months, and 6 months post injection.
adverse effects
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.
Time frame: at 2 weeks, 1 month, 3 months, and 6 months post injection.