Back to resultsEffects of Electrical Stimulation on Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
InterX 5000
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- 50 years of age or older
- Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
- Knee pain of at least six months duration
- Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
- Willing to abide by protocol and treatment schedule.
Exclusion Criteria:
- Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
- Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
- Pregnant or breast-feeding
- Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
- Arthroscopy of the knee within the past year
- Significant injury to the knee within the past 6 months
- Use of assistive devices other than a cane or knee brace
- Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Knee Pain
Secondary Outcome Measures
Knee function
Knee stiffness
Patient global assessment
Health-related quality of life
Full Information
NCT ID
NCT00601497
First Posted
January 12, 2008
Last Updated
January 25, 2008
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT00601497
Brief Title
Effects of Electrical Stimulation on Osteoarthritis of the Knee
Official Title
Effects of Electrical Stimulation on Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
InterX 5000
Other Intervention Name(s)
Noninvasive Interactive Neurostimulation
Intervention Description
20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
Primary Outcome Measure Information:
Title
Knee Pain
Time Frame
Baseline, Week 4, Week 8, and Week 12
Secondary Outcome Measure Information:
Title
Knee function
Time Frame
Baseline, Week 4, Week 8, and Week 12
Title
Knee stiffness
Time Frame
Baseline, Week 4, Week 8, and Week 12
Title
Patient global assessment
Time Frame
Baseline, Week 4, Week 8, and Week 12
Title
Health-related quality of life
Time Frame
Baseline, Week 4, Week 8, and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50 years of age or older
Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
Knee pain of at least six months duration
Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
Willing to abide by protocol and treatment schedule.
Exclusion Criteria:
Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
Pregnant or breast-feeding
Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
Arthroscopy of the knee within the past year
Significant injury to the knee within the past 6 months
Use of assistive devices other than a cane or knee brace
Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann G Taylor, RN, EdD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Electrical Stimulation on Osteoarthritis of the Knee
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