90
Participants
Start Date
October 31, 2015
Primary Completion Date
November 30, 2017
Study Completion Date
November 1, 2017
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).
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.
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."
University of North Carolina at Chapel Hill, Chapel Hill
University of North Carolina, Chapel Hill
OTHER