Arthroplasty, Knee ReplacementTKRNCT05416294
Neurostimulation an Adjuvant Postoperative Analgesic in Total Knee Replacement (TKR) Surgeries
A study testing Primary Relief and Inactive Primary Relief in people with Arthroplasty, Knee Replacement, run by DyAnsys, Inc..
Trial summary
To study and evaluate the effect of using the Primary Relief PENS treatment as adjuvant analgesia for reducing pain in total knee replacement (TKR) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Knee Replacement
- What is being tested?
- Primary Relief and Inactive Primary Relief
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing TKR under regional or general anesthesia and femoral nerve block who consent to participate in the study.
Who cannot join
- 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.
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- 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.
About this study
To study and evaluate the effect of using the Primary Relief PENS treatment as adjuvant analgesia for reducing pain in total knee replacement (TKR) patients.
Read the detailed description
It is a common knowledge that total knee replacement (TKR) surgeries produce great deal of pain in the postoperative period. Superior pain relief is justifiably needed and usually provided. In addition to the conventional methods of pain relief such as continuous epidural block, intrathecal adjuvants, femoral nerve block ± sciatic nerve block, transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical neurostimulation (PENS) have been reported effective by various authors. Recently neurostimulation of auricular nerves via the external auricular surface has shown to alleviate pain after caesarian section. Primary Relief® is percutaneous electrical neuro stimulator designed to administer auricular neurostimulation treatment over 240 hours. Stimulation is performed by sending electrical pulses emitted through needles strategically positioned in the ear. The ear provides numerous points for stimulation within a small area Based on the area of pain relief, chosen points are stimulated. Primary Relief is a miniaturized device designed to administer PENS treatment. Use of this device is recommended for pre-operative, intra-operative and post-operative pain therapy as well as for the treatment of chronic pain.
An advantage over drug therapy is that it avoids the possible side-effects of analgesics and helps in early mobilization following orthopedic surgeries including total knee replacement (TKR), total hip replacement (THR) and shoulder surgeries. Therefore, this study is being undertaken to assess the effect of Primary Relief ® in augmenting pain relief after TKR surgery.
- Conditions
- Arthroplasty, Knee Replacement
- Being tested
- Primary Relief, Inactive Primary Relief
- Keywords
- Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary ReliefDevice
The group will receive PENS treatment using Primary Relief in addition to the multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline) including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine).
Inactive Primary ReliefDevice
The group will receive a sham device with multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline), including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine).
| Study group | Role | What they receive |
|---|---|---|
| Active Device | Experimental | Participants in this arm will receive an active Primary Relief device placed following the total knee replacement surgery. Receives: Device: Primary Relief |
| Placebo Device | Sham comparator | Participants in this arm will receive an inactive (sham) Primary Relief device placed following the total knee replacement surgery. Receives: Device: Inactive Primary Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
To evaluate the pain score in the immediate postoperative period. Pain Score with will be measured on a scale (0 = no pain; 10 = worst imaginable pain).
Measured: 0 - 3 days ; 0,2,4,6,8,10,12,18,24,36,48,60,72 hrs from the time of completion of surgery
Secondary outcomes (3)
NPRS Numerical Pain Rating Scale score post-mobilization
To evaluate the effect of treatment in reducing the average NPRS scores after mobilization. The measurement will record the daily NPRS scores from day three to ten days.
Measured: 4 - 10 days ; 96,120,144,168,192,216,240 hrs from the time of completion of surgery)
Total Use of Analgesics and Opioids
To evaluate the effect of treatment in reducing the overall analgesic and opioid requirement in the immediate postoperative period. The measurement will record the total dose and number of additional analgesics required during the immediate postoperative period at rest.
Measured: OVERALL DOSE IN FIRST 3 DAYS & OVERALL DOSE REQUIRED BETWEEN 4 TO 10 DAYS
KOOS Score The Knee injury and Osteoarthritis Outcome Score ( koos)
To assess the effect of treatment in Quality of life during postoperative period, using the knee injury and osteoarthritis outcome score (KOOS)
Measured: 5 times planned from 0 - 10 day; (i) 24 hrs before Surgery; (ii) 24 Hrs after completion of surgery; (iii) 72 hrs after completion of Surgery; (iv) 120 hrs after completion of Surgery; (v) At the time of device removal -@240 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start15 Aug 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Trial never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Knee ReplacementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DyAnsys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416294
- Sponsor's protocol ID
- CS014
- Acronym
- TKR
- Status last verified
- Sep 2026
- First submitted
- 26 May 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation an Adjuvant Postoperative Analgesic in Total Knee Replacement (TKR) Surgeries
- ClinicalTrials.gov ID
- NCT05416294
- Acronym / sponsor ID
- TKR / CS014
- Conditions
- Arthroplasty, Knee Replacement
- Keywords
- Knee Replacement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DyAnsys, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study and evaluate the effect of using the Primary Relief PENS treatment as adjuvant analgesia for reducing pain in total knee replacement (TKR) patients.
Detailed description
It is a common knowledge that total knee replacement (TKR) surgeries produce great deal of pain in the postoperative period. Superior pain relief is justifiably needed and usually provided. In addition to the conventional methods of pain relief such as continuous epidural block, intrathecal adjuvants, femoral nerve block ± sciatic nerve block, transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical neurostimulation (PENS) have been reported effective by various authors. Recently neurostimulation of auricular nerves via the external auricular surface has shown to alleviate pain after caesarian section. Primary Relief® is percutaneous electrical neuro stimulator designed to administer auricular neurostimulation treatment over 240 hours. Stimulation is performed by sending electrical pulses emitted through needles strategically positioned in the ear. The ear provides numerous points for stimulation within a small area Based on the area of pain relief, chosen points are stimulated. Primary Relief is a miniaturized device designed to administer PENS treatment. Use of this device is recommended for pre-operative, intra-operative and post-operative pain therapy as well as for the treatment of chronic pain.
An advantage over drug therapy is that it avoids the possible side-effects of analgesics and helps in early mobilization following orthopedic surgeries including total knee replacement (TKR), total hip replacement (THR) and shoulder surgeries. Therefore, this study is being undertaken to assess the effect of Primary Relief ® in augmenting pain relief after TKR surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Device | Experimental | Device: Primary ReliefParticipants in this arm will receive an active Primary Relief device placed following the total knee replacement surgery. |
| Placebo Device | Sham comparator | Device: Inactive Primary ReliefParticipants in this arm will receive an inactive (sham) Primary Relief device placed following the total knee replacement surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing TKR under regional or general anesthesia and femoral nerve block who consent to participate in the study.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Primary ReliefThe group will receive PENS treatment using Primary Relief in addition to the multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline) including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine). | Device | Active Device |
| Inactive Primary ReliefThe group will receive a sham device with multimodal analgesia (morphine, ketorolac, methyl, prednisolone, adrenaline), including the periarticular infiltration of local anaesthetic and/or femoral or epidural catheter for postoperative pain management (bupivacaine, ropivacaine). | Device | Placebo Device |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: 0 - 3 days ; 0,2,4,6,8,10,12,18,24,36,48,60,72 hrs from the time of completion of surgery
To evaluate the pain score in the immediate postoperative period. Pain Score with will be measured on a scale (0 = no pain; 10 = worst imaginable pain).
3 secondary outcomes
NPRS Numerical Pain Rating Scale score post-mobilization
Time frame: 4 - 10 days ; 96,120,144,168,192,216,240 hrs from the time of completion of surgery)
Total Use of Analgesics and Opioids
Time frame: OVERALL DOSE IN FIRST 3 DAYS & OVERALL DOSE REQUIRED BETWEEN 4 TO 10 DAYS
KOOS Score The Knee injury and Osteoarthritis Outcome Score ( koos)
Time frame: 5 times planned from 0 - 10 day; (i) 24 hrs before Surgery; (ii) 24 Hrs after completion of surgery; (iii) 72 hrs after completion of Surgery; (iv) 120 hrs after completion of Surgery; (v) At the time of device removal -@240 hrs)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Relief and Inactive Primary Relief in people with Arthroplasty, Knee Replacement, run by DyAnsys, Inc..
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 1 inclusion and 11 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: withdrawn, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numerical Pain Rating Scale (NPRS) (time frame: 0 - 3 days ; 0,2,4,6,8,10,12,18,24,36,48,60,72 hrs from the time of completion of surgery). 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 21 Sep 2026.