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Clinical Trials/NCT00601497
NCT00601497CompletedNot Applicable

Effects of Electrical Stimulation on Osteoarthritis of the Knee

University of Virginia1 site in 1 country39 target enrollmentStarted: December 1, 2004Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
1
Primary Endpoint
Knee Pain
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Intervention: InterX 5000 (Device)

2

Placebo Comparator

Intervention: InterX 5000 (Device)

Outcomes

Primary Outcomes

Knee Pain

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (1)

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