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Effects of Electrical Stimulation on Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00601497
First received: January 12, 2008
Last updated: January 25, 2008
Last verified: January 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014