Recruiting
Phase 2

Botulinum Toxin

Sponsor:

Minneapolis Veterans Affairs Medical Center

Code:

NCT00211679

Conditions

Arthritis

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Botulinum Toxin Type A

Study Details

Brief summary:

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.

Conditions

Arthritis

Pain

Study ID

NCT00211679

Start date

Jun, 2004

Status verified date

Jul, 2005

Completion date

Jun, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Botulinum Toxin Type A

Primary outcome measure

  • Change in Pain Score [ Time Frame: undefined ]
  • Change in Joint Function [ Time Frame: undefined ]
  • Patient Global Assessment [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Maren L Mahowald, MD

6124674190mahow001@umn.edu

Jasvinder A Singh, MD, MPH

6124674190Jasvinder.Singh@va.gov

Locations

Minneapolis VAMC

Recruiting

Minneapolis, Minnesota, United States, 55417

Principal Investigator:

Maren L Mahowald, MD

More Information

Sponsor

Minneapolis Veterans Affairs Medical Center

Last update posted

Sep 21, 2005

Last verified

Jul, 2005

Keywords

  • Joint pain
  • Knee Pain
  • Arthritis
  • Intra-articular Botulinum Toxin Type A

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Veterans Affairs Medical Center on 2005-09-21.