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Intra-articularInjection of Botulinum Toxin Type

Primary Purpose

Arthritis, Pain

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Joint pain, Knee Pain, Arthritis, Intra-articular Botulinum Toxin Type A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Knee 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 Knee 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.

Sites / Locations

  • Minneapolis VAMCRecruiting

Outcomes

Primary Outcome Measures

Change in Pain Score
Change in Joint Function
Patient Global Assessment

Secondary Outcome Measures

Pain Relief
Change in Health Status Quality of Life-SF36
Change in Disease specific Health Related QOL-WOMAC
Function improvement by Timed Stands Test and Range of Motion
Physican Assessment of Pain and Global Assessment of Improvement
Safety Measure,

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Allergan, Center for Veterans Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT00211679
Brief Title
Intra-articularInjection of Botulinum Toxin Type
Official Title
Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Allergan, Center for Veterans Research and Education

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether intra-articular injection of botulinum toxin is effective in the treatment of chronic knee paindue to arthritis.
Detailed Description
Chronic knee pain unresponsive to oral medications and intra-articular corticosteroids and viscosupplements 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 bootulinum toxin type a will be compared to intra-articular injection of lidocaine the saline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Pain
Keywords
Joint pain, Knee Pain, Arthritis, Intra-articular Botulinum Toxin Type A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Primary Outcome Measure Information:
Title
Change in Pain Score
Title
Change in Joint Function
Title
Patient Global Assessment
Secondary Outcome Measure Information:
Title
Pain Relief
Title
Change in Health Status Quality of Life-SF36
Title
Change in Disease specific Health Related QOL-WOMAC
Title
Function improvement by Timed Stands Test and Range of Motion
Title
Physican Assessment of Pain and Global Assessment of Improvement
Title
Safety Measure,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Knee 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 Knee 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maren L Mahowald, MD
Phone
6124674190
Email
mahow001@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jasvinder A Singh, MD, MPH
Phone
6124674190
Email
Jasvinder.Singh@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maren L Mahowad, MD
Organizational Affiliation
Minneapolis VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maren L Mahowald, MD
First Name & Middle Initial & Last Name & Degree
Jasvinder A Singh, MD MPPH
First Name & Middle Initial & Last Name & Degree
Hollis E Krug, MD

12. IPD Sharing Statement

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Intra-articularInjection of Botulinum Toxin Type

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