Clinical trial NCT00211718: Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain
Official title: Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arthritis
Shoulder Pain
Keywords: shoulder pain
arthritis
intra-articular botulinum toxin a
joint pain
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Allergan
name: Center for Veterans Research and Education
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: : Primary Outcomes:
measure: Change in Pain Score
measure: Change in Joint Function
measure: Patient Global Assessment
Secondary outcomes:
measure: Secondary Outcomes:
measure: Pain Relief
measure: Change in Health Status Quality of Life-SF36
measure: Change in Disease specific Health Related QOL-WOOS
measure: Function improvement - Range of Motion, SPADI, Simple Shoulder tes
measure: Physican Assessment of Pain and Global Assessment of Improvement
measure: Safety Measure,
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
Study officials:
affiliation: Minneapolis VAMC
name: Maren L Mahowald, MD
role: PRINCIPAL_INVESTIGATOR
References: