Effects of Electrical Stimulation on Osteoarthritis of the Knee
This study has been completed.
Sponsor:
University of Virginia
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00601497
First received: January 12, 2008
Last updated: January 25, 2008
Last verified: January 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis, Knee |
Device: InterX 5000 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effects of Electrical Stimulation on Osteoarthritis of the Knee |
Resource links provided by NLM:
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- Knee Pain [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Knee function [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]
- Knee stiffness [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]
- Patient global assessment [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]
- Health-related quality of life [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ] [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Start Date: | December 2004 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: InterX 5000
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.
Other Name: Noninvasive Interactive Neurostimulation
|
| Placebo Comparator: 2 |
Device: InterX 5000
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.
Other Name: Noninvasive Interactive Neurostimulation
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601497
Locations
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22903 | |
Sponsors and Collaborators
University of Virginia
Investigators
| Principal Investigator: | Ann G Taylor, RN, EdD | University of Virginia |
More Information
No publications provided
| Responsible Party: | Ann Gill Taylor, RN, EdD, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00601497 History of Changes |
| Other Study ID Numbers: | HIC 11630 |
| Study First Received: | January 12, 2008 |
| Last Updated: | January 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013