Effects of Electrical Stimulation on Osteoarthritis of the Knee

NCT ID: NCT00601497

Last Updated: 2008-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

InterX 5000

Intervention Type DEVICE

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.

2

Group Type PLACEBO_COMPARATOR

InterX 5000

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Noninvasive Interactive Neurostimulation

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia

Principal Investigators

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Ann G Taylor, RN, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HIC 11630

Identifier Type: -

Identifier Source: org_study_id

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