Effects of Electrical Stimulation on Osteoarthritis of the Knee

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: InterX 5000

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Noninvasive Interactive Neurostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knee Pain	Baseline, Week 4, Week 8, and Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Ann G Taylor, RN, EdD, University of Virginia

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: January 12, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Estimate): January 28, 2008
• Last Update Submitted That Met QC Criteria: January 25, 2008
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HIC 11630