Effects of Electrical Stimulation on Osteoarthritis of the Knee

NCT00601497 | Completed

• 1 other identifier: HIC 11630
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Knee Pain

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Device: InterX 5000

2

PLACEBO COMPARATOR

Device: InterX 5000

Interventions

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.

Also known as: Noninvasive Interactive Neurostimulation

1; 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ann G Taylor, RN, EdD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2008
• First Posted: January 28, 2008
• Study Start: December 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: January 28, 2008

Record last verified: 2008-01

Locations

US (1)