Intra-articularInjection of Botulinum Toxin Type

Sponsor

Minneapolis Veterans Affairs Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00211679

Collaborator

Allergan (Industry), Center for Veterans Research and Education (Other)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Pain	Drug: Botulinum Toxin Type A	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study

Study Start Date :

Jun 1, 2004

Study Completion Date :

Jun 1, 2007

Outcome Measures

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, []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.