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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Veterans General Hospital.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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