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

NCT00211718 | Unknown Phase 3

• 1 other identifier: IRB Protocol Number 03404B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Shoulder Pain

Keywords

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

Outcome Measures

Primary Outcomes (4)

• : Primary Outcomes:

• Change in Pain Score

• Change in Joint Function

• Patient Global Assessment

Secondary Outcomes (7)

• 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

Interventions

intra-articular botulinum toxin type a DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• Allergan: collaborator
• Center for Veterans Research and Education: collaborator

Study Sites (1)

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

RECRUITING

MeSH Terms

Conditions

Arthritis; Shoulder Pain; Arthralgia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Maren L Mahowald, MD

  Minneapolis VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maren L Mahowald, MD

CONTACT

6124674190; mahow001@umn.edu

Jasvinder A Singh, MD MPH

CONTACT

6124674190; Jasvinder.Singh@va.gov

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2004
• Study Completion: June 1, 2007
• Last Updated: November 3, 2005

Record last verified: 2005-08

Locations

US (1)