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Intra-articularInjection of Botulinum Toxin Type

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Allergan
Minnesota Veterans Research Institute
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00211679
First received: September 13, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted

September 13, 2005
September 13, 2005
June 2004
Not Provided
  • Change in Pain Score
  • Change in Joint Function
  • Patient Global Assessment
Same as current
No Changes Posted
  • 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,
Same as current
Not Provided
Not Provided
 
Intra-articularInjection of Botulinum Toxin Type
Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Arthritis
  • Pain
Drug: Botulinum Toxin Type A
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2007
Not Provided

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.
Both
18 Years and older
No
Contact: Maren L Mahowald, MD 6124674190 mahow001@umn.edu
Contact: Jasvinder A Singh, MD, MPH 6124674190 Jasvinder.Singh@va.gov
United States
 
NCT00211679
Protocol Number 03393B
Not Provided
Not Provided
Minneapolis Veterans Affairs Medical Center
  • Allergan
  • Minnesota Veterans Research Institute
Principal Investigator: Maren L Mahowad, MD Minneapolis VAMC
Minneapolis Veterans Affairs Medical Center
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP