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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00211718
Recruitment Status : Unknown
Verified August 2005 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : September 21, 2005
Last Update Posted : November 3, 2005
Minnesota Veterans Medical Research and Education Foundation
Information provided by:
Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Arthritis Shoulder Pain Drug: intra-articular botulinum toxin type a Phase 3

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  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial
Study Start Date : July 2004
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Primary Outcome Measures :
  1. : Primary Outcomes:
  2. Change in Pain Score
  3. Change in Joint Function
  4. Patient Global Assessment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211718

Contact: Maren L Mahowald, MD 6124674190
Contact: Jasvinder A Singh, MD MPH 6124674190

United States, Minnesota
Minneapolis VAMC Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Maren l Mahowald, MD    612-467-4190   
Contact: Jasvinder A Singh, MD MPH    6124674190   
Principal Investigator: Maren L Mahowald, MD         
Sub-Investigator: Jasvinder A Singh, MD MPH         
Sub-Investigator: Hollis E Krug, MD         
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Minnesota Veterans Medical Research and Education Foundation
Principal Investigator: Maren L Mahowald, MD Minneapolis VAMC Identifier: NCT00211718     History of Changes
Other Study ID Numbers: IRB Protocol Number 03404B
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 3, 2005
Last Verified: August 2005

Keywords provided by Minneapolis Veterans Affairs Medical Center:
shoulder pain
intra-articular botulinum toxin a
joint pain

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents