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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00211718
• Other study ID #: IRB Protocol Number 03404B
• Status: Recruiting
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: November 2, 2005
• Start date: July 2004
• Est. completion date: June 2007

Study information

• Verified date: August 2005
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: Maren L Mahowald, MD
• Phone: 6124674190
• Email: mahow001[@]umn.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Shoulder Pain

Intervention

Drug:
• intra-articular botulinum toxin type a

Locations

Country	Name	City	State
United States	Minneapolis VAMC	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Allergan, Minnesota Veterans Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	: Primary Outcomes:
Primary	Change in Pain Score
Primary	Change in Joint Function
Primary	Patient Global Assessment
Secondary	Secondary Outcomes:
Secondary	Pain Relief
Secondary	Change in Health Status Quality of Life-SF36
Secondary	Change in Disease specific Health Related QOL-WOOS
Secondary	Function improvement - Range of Motion, SPADI, Simple Shoulder tes
Secondary	Physican Assessment of Pain and Global Assessment of Improvement
Secondary	Safety Measure,