Skip to main content
OpenTrials
Completed

NCT Number: NCT00601497

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InterX 5000

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.

Other names: Noninvasive Interactive Neurostimulation

Primary outcomes

  1. Knee Pain

    Time frame: Baseline, Week 4, Week 8, and Week 12

Secondary outcomes

  1. Knee function

    Time frame: Baseline, Week 4, Week 8, and Week 12

  2. Knee stiffness

    Time frame: Baseline, Week 4, Week 8, and Week 12

  3. Patient global assessment

    Time frame: Baseline, Week 4, Week 8, and Week 12

  4. Health-related quality of life

    Time frame: Baseline, Week 4, Week 8, and Week 12

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 28, 2008
Registry last updated
Jan 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.