Effects of Electrical Stimulation on Osteoarthritis of the Knee

Osteoarthritis, Knee Clinical Trial

Official title:

Effects of Electrical Stimulation on Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601497
• Other study ID #: HIC 11630
• Status: Completed
• Phase: N/A
• First received: January 12, 2008
• Last updated: January 25, 2008
• Start date: December 2004
• Est. completion date: July 2006

Study information

• Verified date: January 2008
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Pain		Baseline, Week 4, Week 8, and Week 12	No
Secondary	Knee function		Baseline, Week 4, Week 8, and Week 12	No
Secondary	Knee stiffness		Baseline, Week 4, Week 8, and Week 12	No
Secondary	Patient global assessment		Baseline, Week 4, Week 8, and Week 12	No
Secondary	Health-related quality of life		Baseline, Week 4, Week 8, and Week 12	No