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

Official Title

Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial.

Conditions

  • Arthritis
  • Shoulder Pain

Study Type

Interventional

Study Design

Treatment, Randomised, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

  • Change in Pain Score
  • Change in Joint Function
  • Patient Global Assessment

Secondary Outcome Measures:

  • Secondary Outcomes:
  • Pain Relief
  • Change in Disease specific Health Related QOL-WOOS
  • Function improvement – Range of Motion, SPADI, Simple Shoulder tes
  • Physican Assessment of Pain and Global Assessment of Improvement
  • Safety Measure,

Study Start

July 2004

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older.
  • Written informed consent and written authorisation 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.

Total Enrolment

40

Contact Details

Maren L Mahowald, MD
6124674190
mahow001@umn.edu   

Jasvinder A Singh, MD MPH
6124674190
Jasvinder.Singh@va.gov 

Location:

Minneapolis VAMC
Minneapolis, Minnesota
United States, 55417