Knee Osteoarthritis Clinical Trial
Official title:
Phase III Study Investigating the Effects of 6-weeks of Neuromuscular Electrical Stimulation (NMES) Peri-total Knee Arthroplasty (TKA).
Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test.
Knee osteoarthritis is a severe debilitating condition that greatly impacts patient quality
of life, function, emotional well-being and everyday pain levels. Total knee arthroplasty
(TKA) is performed as a means of alleviating these symptoms in the long term however short
term muscle weakness following surgery can elicit its own detrimental effect on performance
and activities of daily living. This underlines the importance of mitigating strength loss
in the immediate post-operative period.
Recent reviews suggest that Neuromuscular Electrical Stimulation (NMES) of the quadriceps
femoris muscle can be beneficial in the rehabilitation period following knee surgery. It
appears that early use of NMES can help to recover exercise capacity in the muscle, thus
allowing the patient to benefit more from volitional exercise therapy later in the
rehabilitation period1. This in turn can lead to accelerated recovery and improved outcomes.
A recent and as yet unpublished study of 96 patients following ACL reconstruction has
demonstrated a clear benefit to the use of Kneehab. The benefit seemed to accrue in the
six-week post-operative period.
A recent pilot study by Walls 2 also suggests that NMES applied in the immediate
pre-operative period before TKA leads to increased muscle strength and improved functional
abilities. Previously, Mizner (2005) has shown pre operative strength to be a good predictor
of functional outcome 1 year after surgery3. This proposed study aims to examine whether
NMES applied in the peri-operative timeframe, 6 weeks before and 6 weeks after, can improve
outcomes for patients undergoing total knee replacement. The rationale for this approach is
that NMES can help prepare the quadriceps muscle for the rehabilitation phase by building
exercise capacity before the operation. The immediate deficit, which normally follows knee
surgery, would therefore be compensated to some extent and the post-operative NMES treatment
would be expected to counteract the activation inhibition that is thought to occur in the
early weeks following surgery. Overall, the patient would be in a better position to benefit
from conventional rehabilitation exercises aimed at improved co-ordination and functional
performance.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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