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Tiny electric pulses tested to curb pain after knee replacement
NCT ID NCT05416294
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether a device that sends mild electrical pulses through the skin, called PENS, can ease pain after total knee replacement. Patients having knee replacement surgery receive either the real PENS device or a sham device, both alongside standard pain medicines. The trial measures pain scores right after surgery and during movement in the days that follow, and tracks how much opioid painkiller patients use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PENS treatment using the Primary Relief device
- What this could lead to
- If it works, PENS could become an added option for easing pain after knee replacement and cutting how much opioid painkiller patients need.
- What could go wrong
- This is an early device study, so results may not hold up in larger groups. Nerve stimulation can cause skin irritation or discomfort at the electrode site, and some patients may not respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
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Aug 2022
An estimate. Start dates often move.
- Expected to finish
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Dec 2024
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients undergoing TKR under regional or general anesthesia and femoral nerve block who consent to participate in the study. Exclusion Criteria: * ASA 3 or 4 * Those receiving psychiatric medication * Those with infection at the site of application. The following data will be collected * Intraoperative use of local anesthetics, opioids and other analgesics * Postoperative details as to the time of application of the device. NPRS in both the groups at multiple intervals, on demand analgesic requirement, overall analgesic consumption during the study period, quality of life questionnaire at the end of the study period and relevant postoperative complications will be noted. * Rescue analgesics will be considered for breakthrough pain or NPRS \> 4. Intravenous Tramadol 50mg will be the first rescue analgesic and if pain is not relieved with Tramadol, opiods will be considered. Non steroidal anti inflammatory drugs will be considered to supplement the above medications if there is no contraindication and if need arises. * NPRS score will be noted at multiple intervals for 10 days. * Any nausea, vomiting, giddiness, intolerance to the device will also be noted. * During the follow up, quality of life questionnaire would be administered and the result noted. The device will be removed after 10 days of its application. Any redness at the site of application or pain at the site are noted. The study will end with the removal of the device.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.