The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

November 30, 2017

Study Completion Date

November 1, 2017

Conditions
Knee Osteoarthritis
Interventions
DEVICE

Transcutaneous Electrical Nerve Stimulation

TENS is FDA approved for the purposes in which we will be applying the modality (21CFR882.5890; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=882.5890, these TENS Units have been acquired by the PI, who is a licensed Allied Health Professional in the state of North Carolina).

OTHER

Therapeutic Exercise

Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. The intervention will consist of 10 45-minute sessions.

DEVICE

Sham Transcutaneous Electrical Nerve Stimulation

"Sham TENS+TE patients will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN) specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (\~20 seconds) that will become sub-sensory in nature. The participants will wear the Sham TENS for 8 hours per day."

Trial Locations (1)

27599

University of North Carolina at Chapel Hill, Chapel Hill

All Listed Sponsors
lead

University of North Carolina, Chapel Hill

OTHER

NCT02634814 - The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis | Biotech Hunter | Biotech Hunter