The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- All knee OA participants must exhibit symptomatic knee OA, which we will define as a normalized, person based, Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 31 (out of 100 points, indicating most dysfunction),38 radiographic evidence of tibiofemoral OA (2-4 on the Kellgren - Lawrence scale) 39 and neuromuscular activation deficits, defined as quadriceps neuromuscular activation of less than 90% in the involved leg.3 Participants between the ages of 40 and 75 years old will be included.
Exclusion Criteria:
- Patients will also be excluded if they have: 1) been diagnosed with a cardiovascular condition restricting exercise; 2) had a corticosteroid or hyaluronic acid injection in the involved knee in the previous 6-months; 3) a pacemaker; 4) a neurodegenerative condition; 5) rheumatoid arthritis; 6) cancer; 7) neural sensory dysfunction over the knee 8) a BMI over 35; 9) history of lower extremity orthopaedic surgery in the past year; 10) a history of a traumatic knee injury in the past 6 months; 11) any history of a total knee arthroplasty in either extremity; or 12) a diagnosed, non-reconstructed knee ligament tear. Patients needing an assistive device to walk and pregnant females will also be excluded.
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Sham Comparator
Active Comparator
TENS and Therapeutic Exercise
Sham TENS and Therapeutic Exercise
Therapeutic Exercise Only
Patients assigned to the TENS+Therapeutic Exercise (TE) group will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN), and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). 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.
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. 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 role of the comparison group is to provide data on how traditional TE affects the outcome measures. The TE only group will allow us to assess how the addition of TENS to traditional TE will augment the effects of traditional TE. 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.