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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Minneapolis Veterans Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Allergan
Minnesota Veterans Research Institute
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00211718
First received: September 14, 2005
Last updated: November 2, 2005
Last verified: August 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00211718     History of Changes
Other Study ID Numbers: IRB Protocol Number 03404B
Study First Received: September 14, 2005
Last Updated: November 2, 2005
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

Additional relevant MeSH terms:
Arthritis
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014