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

NCT ID: NCT00211718

Last Updated: 2005-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-06-30

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.

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).

Conditions

Arthritis; Shoulder Pain

Keywords

shoulder pain; arthritis; intra-articular botulinum toxin a; joint pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

intra-articular botulinum toxin type a

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Center for Veterans Research and Education

OTHER

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: lead

Principal Investigators

Maren L Mahowald, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VAMC

Locations

Minneapolis VAMC

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maren L Mahowald, MD

Role: CONTACT

Phone: 6124674190

Email: mahow001@umn.edu

Jasvinder A Singh, MD MPH

Role: CONTACT

Phone: 6124674190

Email: Jasvinder.Singh@va.gov

Facility Contacts

Maren l Mahowald, MD

Role: primary

Jasvinder A Singh, MD MPH

Role: backup

Other Identifiers

IRB Protocol Number 03404B

Identifier Type: -

Identifier Source: org_study_id