Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shu-Fen Sun, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01760577
First received: December 30, 2012
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Ankle Osteoarthritis
Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)
Drug: Hyalgan (Hyalgan, Fidia , Italy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Ankle Osteoarthritis Scale (AOS) score [ Time Frame: at 6 months after the injection ] [ Designated as safety issue: No ]
    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:
  • AOFAS ankle/hindfoot score [ Time Frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 70
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760577

Locations
Taiwan
Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Shu-Fen Sun, MD Kaohsiung Veterans General Hospital, Taiwan
  More Information

Publications:
Sun SF, Hsu CW, Sun HP, et al. The effect of three weekly intra-articular injections of hyaluronate on pain, function, and balance in patients with unilateral ankle arthritis . J Bone Joint Surg Am 2011;93:1720-6.

Responsible Party: Shu-Fen Sun, MD, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01760577     History of Changes
Other Study ID Numbers: VGHKS100-061
Study First Received: December 30, 2012
Last Updated: January 3, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
osteoarthritis, botulinum toxin, hyaluronate

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Hyaluronic Acid
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 18, 2014