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Intra-articularInjection of Botulinum Toxin Type
This study is currently recruiting participants.
Verified by Minneapolis Veterans Affairs Medical Center, July 2005
Sponsors and Collaborators: Minneapolis Veterans Affairs Medical Center
Allergan
Minnesota Veterans Research Institute
Information provided by: Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00211679
  Purpose

The purpose of this study is to determine whether intra-articular injection of botulinum toxin is effective in the treatment of chronic knee paindue to arthritis.


Condition Intervention Phase
Arthritis
Pain
Drug: Botulinum Toxin Type A
Phase II

MedlinePlus related topics: Botox
Drug Information available for: Clostridium botulinum toxin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in Pain Score
  • Change in Joint Function
  • Patient Global Assessment

Secondary Outcome Measures:
  • Pain Relief
  • Change in Health Status Quality of Life-SF36
  • Change in Disease specific Health Related QOL-WOMAC
  • Function improvement by Timed Stands Test and Range of Motion
  • Physican Assessment of Pain and Global Assessment of Improvement
  • Safety Measure,

Estimated Enrollment: 40
Study Start Date: June 2004
Estimated Study Completion Date: June 2007
Detailed Description:

Chronic knee pain unresponsive to oral medications and intra-articular corticosteroids and viscosupplements is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter.

Comparisons: Intra-articular injection of bootulinum toxin type a will be compared to intra-articular injection of lidocaine the saline.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older.

    • Written informed consent and written authorization for use or release of health and research study information have been obtained.
    • Subject has chronic Knee pain for more than 1 year.
    • Subject has pain >4.5 on numerical rating scale of 0 to 10.
    • Ability to follow study instructions and likely to complete all required visits.
    • Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable)
    • Patients previously treated with intra-articular corticosteroid or viscosupplementation injections.
    • Patients with rheumatoid arthritis must have failed therapy with standard DMARDs (disease modifying anti-rheumatic drugs) and anti-TNF agents unless they have a contraindication to TNF blockers.
    • Patients who were considered not to be candidates for Knee joint replacement because of young age, abnormalities in periarticular tissues or because of co-morbid conditions.
    • Must be ambulatory and able to perform sit to stand.

Exclusion Criteria:

  • Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
  • Any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy.
  • Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
  • Known allergy or sensitivity to any of the components in the study medication.
  • Evidence of recent alcohol or drug abuse.
  • Infection at injection site or systemic infection (postpone study entry until one week following recovery.
  • Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months.
  • Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit
  • Patients on coumadin or heparin because of increased risk of bleeding in the joint
  • Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211679

Contacts
Contact: Maren L Mahowald, MD 6124674190 mahow001@umn.edu
Contact: Jasvinder A Singh, MD, MPH 6124674190 Jasvinder.Singh@va.gov

Locations
United States, Minnesota
Minneapolis VAMC Recruiting
Minneapolis, Minnesota, United States, 55417
Principal Investigator: Maren L Mahowald, MD            
Sub-Investigator: Jasvinder A Singh, MD MPPH            
Sub-Investigator: Hollis E Krug, MD            
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Allergan
Minnesota Veterans Research Institute
Investigators
Principal Investigator: Maren L Mahowad, MD Minneapolis VAMC
  More Information

Study ID Numbers: Protocol Number 03393B
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00211679  
Health Authority: United States: Food and Drug Administration

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Joint pain
Knee Pain
Arthritis
Intra-articular Botulinum Toxin Type A

Study placed in the following topic categories:
Botulinum Toxins
Musculoskeletal Diseases
Joint Diseases
Arthritis
Pain
Botulinum Toxin Type A
Arthralgia

Additional relevant MeSH terms:
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009