Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01760577|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ankle Osteoarthritis||Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA) Drug: Hyalgan (Hyalgan, Fidia , Italy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||November 2012|
Experimental: The Botulinum Toxin A group
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.
Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)
patients received intraarticular injections by the same experienced physician using aseptic procedures.
Other Name: 100 units of Botulinum Toxin A in 2 cc NS
Active Comparator: The hyaluronate group (Hyalgan, 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 .
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.
Other Name: 2 ml Hyalgan, molecular weight 500-730kDa, Fidia , Italy
- Ankle Osteoarthritis Scale (AOS) score [ Time Frame: 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
- AOFAS ankle/hindfoot score [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760577
|Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road|
|Kaohsiung, Taiwan, 813|
|Principal Investigator:||Shu-Fen Sun, MD||Kaohsiung Veterans General Hospital, Taiwan|