Effects of Electrical Stimulation on Osteoarthritis of th... | NCT00601497

Studies
Effects of Electrical Stimulation on Osteoarthritis of the Knee

NCT00601497

Sponsor

University of Virginia

Status

Completed

Last Update Posted

Jan 28, 2008Estimated

Enrollment

39Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Knee

Interventions

InterX 5000

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Jan 12, 2008

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2008

Last Update Posted Date

Jan 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: InterX 5000
2	Placebo Comparator		Device: InterX 5000

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Pain		Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Knee function		Baseline, Week 4, Week 8, and Week 12
Knee stiffness		Baseline, Week 4, Week 8, and Week 12
Patient global assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann G Taylor, RN, EdD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22903	United States

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided