Knee Osteoarthritis
Conditions
Brief summary
This study will examine the effects, if any, of using muscle stimulation on the quadriceps following a total knee replacement. Secondary objectives will be to evaluate and compare pain levels, qualitative outcomes, and the impact of NMES on pain medication requests between groups. It is possible that strengthening the quadriceps muscles and improving their activation will reduce postoperative pain and help patients return to activities sooner than with standard therapy alone.
Detailed description
Neuromuscular electrical stimulation (NMES) for muscle strengthening and training has been in use since the 1970s, but questions still remain regarding its effectiveness with different patient populations, the duration of use and specifics regarding the stimulation itself, such as length and type of electrical impulse. NMES works by passing electrical impulses through the muscles to get them to contract. These impulses mimic the body's natural neural activity (action potential) to cause a contraction. The goal with NMES is to strengthen the muscle sooner by using muscle re-education. The quadriceps is weakened and sometimes slow to respond after knee surgery. A weak quadriceps muscle after surgery can be a contributing factor to dissatisfaction with the surgical result. When the quadriceps are weak or not firing properly, forces are transferred to areas such as the knee joint placing an additional strain on the replaced joint and contributing to knee pain, swelling and inflammation. If we can get patients' quads firing better and sooner, we hope we would also see better short-term and long-term functional outcomes and more long-term satisfaction than is presently reported. Study Enrollment We are looking for 60 patients to participate. We are randomly assigning 30 participants to receive the standard therapy regimen and 30 to follow the standard therapy regimen with the addition of using an NMES treatment twice a day, every day, for a ten-week period. Patients in the therapy with NMES treatment group will keep a tracking log of their use at home and will turn in the units at the 10-week appointment. The unit is easy to use and all participants are given specific instructions on its use. All participants complete baseline muscle testing before their surgery and then again at two-week, six-week, ten-week, and one-year appointments. The muscle testing consists of a battery of functional measures to assess the quadriceps such as the Timed Up and Go test (TUG), Six Minute Walk test (6MWT), Single Limb Stance (SLS) and others. All testing is conducted at Indiana Orthopaedic Hospital South's physical therapy department. When designing this study we worked closely with the department to make sure the intended tests were appropriate both for our study and the facility; the input from the staff was and continues to be integral to this study's success. It is too early to report any findings and we are still enrolling patients. If effective, the NMES treatment should improve quadriceps activation and functioning early on after surgery, which will hopefully allow the patient to experience less pain and have a quicker functional recovery than a patient who did not use the NMES. Only time will tell if this is a logical conclusion and if NMES as a standard postoperative therapy would be beneficial for our patients. We anxiously await the outcome of the study.
Interventions
DEVICECompex Rehab
Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.
Sponsors
DJO Incorporated
Orthopaedic Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is a candidate for unilateral primary total knee arthroplasty and has a primary diagnosis of osteoarthritis. * Patient is a male or non-pregnant female age 18 and older at time of surgery. * Patient has signed an Institutional review board (IRB)-approved, study-specific informed consent form. * Patient is willing and able to comply with the postoperative scheduled clinical evaluations and rehabilitation.
Exclusion criteria
* Patient has active infection within the affected knee joint. * Patient requires revision surgery of a previously implanted total knee arthroplasty. * Patient is morbidly obese, defined as having a body mass index (BMI) greater than or equal to 36. * Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the intervention. * Patient has been diagnosed with a systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (e.g. Paget's disease, renal osteodystrophy, etc.). * Patient has a history of cardiac issues including myocardial infarction and/or has a pacemaker. * Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day. * Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule. * Patient is a prisoner. * Patient has indication for contralateral total knee arthroplasty within the evaluation window.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quadriceps Force | Baseline and 1-year Follow-up | Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 1-year postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline measurement to 1-year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS Pain Scores | Baseline and 1-year Follow-up | Average Visual Analog Scale (VAS) pain scores were computed for baseline and 1-year visits for each study arm. This measure is the difference between the average pain score at the baseline and 1-year follow-ups (1-year minus Baseline), stratified by study arm. The scale ranges from 0 to 10, with 0 being No Pain and 10 being Pain as bad as it could possibly be. Lower scores indicate lower levels of reported pain. Negative scores indicate a reduction in pain from baseline to 1-year. |
Countries
United States
Participant flow
Pre-assignment details
60 patients were consented, but due to the gap between the consenting appointment and the baseline appointment, many patients failed to complete their baseline appointment or rescheduled/canceled their surgeries. Only patients attending the baseline appointment were considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Standard Therapy This arm of the study will follow the standard therapy course after total knee arthroplasty. | 19 |
| Standard Therapy + NMES This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device.
Compex Rehab: Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated. | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Standard Therapy | Standard Therapy + NMES | Total |
|---|---|---|---|
| Age, Continuous | 61 years | 62 years | 62 years |
| Quad Force | 276.8 Newtons (N) | 291.1 Newtons (N) | 282.38 Newtons (N) |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 2 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 1 / 21 |
Outcome results
Primary
Change in Quadriceps Force
Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 1-year postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline measurement to 1-year.
Time frame: Baseline and 1-year Follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Therapy | Change in Quadriceps Force | 49.0 Newtons (N) |
| Standard Therapy + NMES | Change in Quadriceps Force | 28.4 Newtons (N) |
Secondary
Change in VAS Pain Scores
Average Visual Analog Scale (VAS) pain scores were computed for baseline and 1-year visits for each study arm. This measure is the difference between the average pain score at the baseline and 1-year follow-ups (1-year minus Baseline), stratified by study arm. The scale ranges from 0 to 10, with 0 being No Pain and 10 being Pain as bad as it could possibly be. Lower scores indicate lower levels of reported pain. Negative scores indicate a reduction in pain from baseline to 1-year.
Time frame: Baseline and 1-year Follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Therapy | Change in VAS Pain Scores | -1.06 score on a scale |
| Standard Therapy + NMES | Change in VAS Pain Scores | -1.07 score on a scale |