Knee OsteoarthritisNCT01844193
Early Postoperative Compex Rehab NMES Use for Total Knee Arthroplasty Patients
A study testing Compex Rehab in people with Knee Osteoarthritis, run by Orthopaedic Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Compex Rehab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-Month Prospective, Post-Market Study of Early Postoperative Compex® Rehab NMES Use in Total Knee Arthroplasty Patients
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Compex Rehab
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compex RehabDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | No intervention | This arm of the study will follow the standard therapy course after total knee arthroplasty. |
| Standard Therapy + NMES | Experimental | 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. Receives: Device: Compex Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1-year Follow-up
Secondary outcomes (1)
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.
Measured: Baseline and 1-year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
- Investigators
- Frank R Kolisek, MD, Principal investigator, OrthoIndy South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844193
- Sponsor's protocol ID
- DJO-NMES-12
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2013
- Last updated
- 12 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month Prospective, Post-Market Study of Early Postoperative Compex® Rehab NMES Use in Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT01844193
- Acronym / sponsor ID
- DJO-NMES-12
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Orthopaedic Research FoundationUniversity, hospital or other
- Collaborators
- DJO Incorporated
- Study start
- Jan 2013
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 12 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | No intervention | –This arm of the study will follow the standard therapy course after total knee arthroplasty. |
| Standard Therapy + NMES | Experimental | Device: Compex RehabThis 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compex RehabParticipants 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. | Device | Standard Therapy + NMES |
Primary outcome
Change in Quadriceps Force
Time frame: 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.
1 secondary outcome
Change in VAS Pain Scores
Time frame: Baseline and 1-year Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank R Kolisek, MD principal investigator
OrthoIndy South
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compex Rehab in people with Knee Osteoarthritis, run by Orthopaedic Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quadriceps Force (time frame: Baseline and 1-year Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.