The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for
      the novel indication of treating neuromuscular activation in individuals with knee
      osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to
      improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced
      rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating
      underlying neuromuscular activation deficits. The investigators seek to use TENS to excite
      neural pathways that immediately increase neuromuscular activation as well as cause sustained
      improvements in neuromuscular activation and greater strength gains in knee OA patients
      compared to traditional TE. The investigators will evaluate the effect of TENS+TE on muscle
      strength, neuromuscular activation, gait biomechanics, physical function, physical activity,
      self-efficacy of physical activity, self-reported quality of life, disability and pain. The
      central hypothesis is that an enhanced TENS+TE intervention will lead to better clinical
      outcomes, increased physical activity, and improved general health. The rationale for
      conducting a small clinical trial, which demonstrates the feasibility and establishes the
      preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the
      development of a future larger clinical trial to establish the efficacy of an enhanced
      rehabilitation strategy for knee OA. This hypothesis will be tested through two specific
      aims: 1) to collect and report data on the feasibility of conducting a clinical trial to
      evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating
      patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a
      4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength,
      neuromuscular activation, gait biomechanics, physical function, physical activity,
      self-efficacy of physical activity, self reported quality of life, disability, and pain in
      knee OA patients. Posttests will be at 4 and 8-weeks following baseline.
    


Intervention name(s): Transcutaneous Electrical Nerve Stimulation; Therapeutic Exercise; Sham Transcutaneous Electrical Nerve Stimulation
Intervention type(s): Device; Other; Device
Intervention description(s): 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).; 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 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.
Other intervention name(s): TENS; Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment