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

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

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

Study Overview

• Status: Unknown
• Conditions: Arthritis; Shoulder Pain
• Intervention / Treatment: Drug: intra-articular botulinum toxin type a

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).

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Maren L Mahowald, MD; Phone Number: 6124674190; Email: mahow001@umn.edu
• Study Contact Backup: Name: Jasvinder A Singh, MD MPH; Phone Number: 6124674190; Email: Jasvinder.Singh@va.gov

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Minneapolis VAMC
      • Principal Investigator: Maren L Mahowald, MD
      • Sub-Investigator: Hollis E Krug, MD
      • Contact: Jasvinder A Singh, MD MPH; Phone Number: 6124674190; Email: Jasvinder.Singh@va.gov
      • Contact: Maren l Mahowald, MD; Phone Number: 612-467-4190; Email: mahow001@umn.edu
      • Sub-Investigator: Jasvinder A Singh, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in Pain Score
Change in Joint Function
Patient Global Assessment
: Primary Outcomes:

Secondary Outcome Measures

Outcome Measure
Pain Relief
Change in Health Status Quality of Life-SF36
Physican Assessment of Pain and Global Assessment of Improvement
Safety Measure,
Secondary Outcomes:
Change in Disease specific Health Related QOL-WOOS
Function improvement - Range of Motion, SPADI, Simple Shoulder tes

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Collaborators: Allergan; Center for Veterans Research and Education
• Investigators: Principal Investigator: Maren L Mahowald, MD, Minneapolis VAMC

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion: June 1, 2007

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): November 3, 2005
• Last Update Submitted That Met QC Criteria: November 2, 2005
• Last Verified: August 1, 2005

More Information

Terms related to this study

• Keywords: joint pain; arthritis; shoulder pain; intra-articular botulinum toxin a
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Arthritis; Shoulder Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: IRB Protocol Number 03404B