Intra-articularInjection of Botulinum Toxin Type
Status: | Completed |
---|---|
Conditions: | Arthritis, Chronic Pain |
Therapuetic Areas: | Musculoskeletal, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | June 2004 |
End Date: | June 2007 |
Contact: | Maren L Mahowald, MD |
Email: | mahow001@umn.edu |
Phone: | 6124674190 |
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.
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.
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.
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.
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