Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

January 3, 2013 updated by: Shu-Fen Sun, Kaohsiung Veterans General Hospital.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital, No 386, Ta-Chung 1st Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 2 ml Hyalgan, molecular weight 500-730kDa, Fidia , Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 6 months after the injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.
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)
pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
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
pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
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.
pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection
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.
at 2 weeks, 1 month, 3 months, and 6 months post injection.
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.
at 2 weeks, 1 month, 3 months, and 6 months post injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Shu-Fen Sun, MD, Kaohsiung Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 30, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS100-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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