Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain

Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids
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 botulinum toxin type a will be compared to
intra-articular injection of placebo ( lidocaine then 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 Shoulder joint 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 Shoulder 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.