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

This study is currently recruiting participants.
Verified by Minneapolis Veterans Affairs Medical Center, August 2005

Sponsors and Collaborators: Minneapolis Veterans Affairs Medical Center
Allergan
Minnesota Veterans Research Institute
Information provided by: Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00211718
  Purpose

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 Intervention Phase
Arthritis
Shoulder Pain
Drug: intra-articular botulinum toxin type a
Phase III

MedlinePlus related topics:   Botox   

ChemIDplus related topics:   Clostridium botulinum toxin    Botulinum toxin A   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

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

Secondary Outcome Measures:
  • Secondary Outcomes:
  • Pain Relief
  • Change in Health Status Quality of Life-SF36
  • 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,

Estimated Enrollment:   40
Study Start Date:   July 2004
Estimated Study Completion Date:   June 2007

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

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211718

Contacts
Contact: Maren L Mahowald, MD     6124674190     mahow001@umn.edu    
Contact: Jasvinder A Singh, MD MPH     6124674190     Jasvinder.Singh@va.gov    

Locations
United States, Minnesota
Minneapolis VAMC     Recruiting
      Minneapolis, Minnesota, United States, 55417
      Contact: Maren l Mahowald, MD     612-467-4190     mahow001@umn.edu    
      Contact: Jasvinder A Singh, MD MPH     6124674190     Jasvinder.Singh@va.gov    
      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
Allergan
Minnesota Veterans Research Institute

Investigators
Principal Investigator:     Maren L Mahowald, MD     Minneapolis VAMC    
  More Information


Study ID Numbers:   IRB Protocol Number 03404B
First Received:   September 14, 2005
Last Updated:   November 2, 2005
ClinicalTrials.gov Identifier:   NCT00211718
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Signs and Symptoms
Botulinum Toxins
Musculoskeletal Diseases
Shoulder Pain
Joint Diseases
Arthritis
Pain
Botulinum Toxin Type A
Arthralgia

Additional relevant MeSH terms:
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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