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Completed

NCT Number: NCT01760577

Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

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.

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Key information

Conditions

Ankle Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum Toxin A (Allergan, Inc, Irvine CA)

Drug

patients received intraarticular injections by the same experienced physician using aseptic procedures.

Other names: 100 units of Botulinum Toxin A in 2 cc NS

Hyalgan (Hyalgan, Fidia , Italy)

Drug

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 names: 2 ml Hyalgan, molecular weight 500-730kDa, Fidia , Italy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 4, 2013
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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