Effects of Electrical Stimulation on Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: InterX 5000

• Registration Number: NCT00601497
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-01
• Study First Submitted: 2008-01-12
• Study First Submitted QC: 2008-01-25
• Last Update Submitted: 2008-01-25
• Study First Posted: 2008-01-28
• Last Update Posted: 2008-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	InterX 5000	-
2	InterX 5000	-

Primary Outcome Measures

Name	Time	Method
Knee Pain	Baseline, Week 4, Week 8, and Week 12

Secondary Outcome Measures

Name	Time	Method
Knee function	Baseline, Week 4, Week 8, and Week 12
Knee stiffness	Baseline, Week 4, Week 8, and Week 12
Patient global assessment	Baseline, Week 4, Week 8, and Week 12
Health-related quality of life	Baseline, Week 4, Week 8, and Week 12

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States