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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
Sponsor:
Information provided by (Responsible Party):
Shu-Fen Sun, Kaohsiung Veterans General Hospital.

Tracking Information
First Submitted Date  ICMJE December 30, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis
Official Title  ICMJE Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ankle Osteoarthritis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)
  • 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 .
    Intervention: Drug: Hyalgan (Hyalgan, Fidia , Italy)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760577
Other Study ID Numbers  ICMJE VGHKS100-061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shu-Fen Sun, Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shu-Fen Sun, MD Kaohsiung Veterans General Hospital, Taiwan
PRS Account Kaohsiung Veterans General Hospital.
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP