The KNEEhabilitation Study: Improving Disability in Individuals With Knee Osteoarthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 3/8/2019 |
| Start Date: | October 2015 |
| End Date: | November 1, 2017 |
Improving Disability in Knee Osteoarthritis by Targeting Neuromuscular Deficits
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.
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.
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.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-962-3617
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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