Ankle Osteoarthritis
Conditions
Keywords
osteoarthritis, botulinum toxin, hyaluronate
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.
Interventions
patients received intraarticular injections by the same experienced physician using aseptic procedures.
DRUGHyalgan (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.
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Taiwan
Outcome results
None listed