Acute PainNCT03834142
NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries
A study testing NSS-2 Bridge in people with Acute Pain and Arthropathy of Knee, run by Jacques E. Chelly at 3 sites in United States.
Trial summary
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- NSS-2 Bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Mar 2019to 30 Jun 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Elective Total Knee OR Total Hip Arthroplasties OR Kidney transplant surgery OR Bariatric surgery
Who cannot join
- History of active depression, anxiety or catastrophizing
- Active alcoholism or drug abuse
- Severe chronic pain condition that requires daily preoperative opioid dependence
- History of hemophilia
- Patients with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators)
- Patients with psoriasis vulgaris diagnosis
- Women who are pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Pilot Study to Investigate the Feasibility and Tolerability of the Use of NSS-2-BRIDGE Device for Post-Operative Pain in Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. Therefore, in order to combat this growing health crisis at the ground level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical population in order to change the incidence of post-operative opioid addiction.
Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of auricular stimulation for the perioperative management of pain in surgical patients, despite the demonstration that auriculotherapy has been shown to relieve pain in the postoperative setting.
The NSS-2- BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major orthopedic surgery such as knee and hip arthroplasties. The use of the NSS-2 BRIDGE device has been demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and clinical trials are ongoing to assess the benefit of this approach for post-operative pain management. As compared to the present use of opioids for perioperative pain management, the use of a complementary, non-pharmacologic approach offers the advantage of analgesia without the associated side effects.
Read the detailed description
An open-label, pilot study will investigate forty individuals, ten of which will be scheduled for total hip arthroplasty, ten will be scheduled for total knee arthroplasty, ten scheduled for kidney transplant and ten for bariatric surgery, will be approached and consented for this trial. Their data in regards to their post-operative pain, nausea, and analgesia use will be compared to 10 historic subjects who had the same surgeries in January (TKA/THA) or September (kidney transplant/bariatric) of 2019. The subjects who receive the NSS-2-BRIDGE will also be monitored for comfort with the device for the tolerability and feasibility of utilizing this device in the future to treat post-operative pain.
Once a patient has given and signed informed consent to participate in the study, demographic information and medical history will be collected from each participant on the day of the joint replacement/kidney transplant/bariatric surgery. Data will be de-identified and kept in a locked cabinet in a locked office. The PI and the research coordinator have been trained in placing the NSS-2-BRIDGE and will apply the device in the immediate post-operative setting (post-anesthesia care unit, PACU). The device will be attached behind the ear with double-sided tape. It contains three electrodes which will be applied to the ear and a ground which will be placed on the patient's lobe. Each electrode and the ground will be secured with adhesive bandages. The patient will be informed at the time of consent and after the implantation of the device that they can have the device removed any time after its application. Once the device is placed patients will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" they must pinch down on the electrodes and ground to ensure they are still placed in their designated locations and have not come loose.
As per standard of care, at 24, 48, 72, 96 and 120 hours post-operatively pain scores will be collected at rest and movement, total opioid consumption, as well as the devise tolerability. Additionally as per other pain pilot IRB approved projects, we shall also collect common medical information including time to bowel movement, PONV, time to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain related issues, quality of recovery after joint replacement, overall patient satisfaction, and patient satisfaction related to pain management.
When the patient is discharged from the hospital, they will be asked to complete a patient satisfaction survey. If the patient should be discharged prior to 120 hours post-operatively, they will be asked to wear the device home. They will also be ask to remove the device at 120 hours (five days) after device placement and dispose of it in their home. We will provide removal instructions. Data post- hospital discharge regarding pain scores, opioid consumption, and device tolerability will be collected after discharge by calling the patient every day for 120 hr. following the placement of the device.
At UPMC Shadyside, we expect the patients undergoing primary unilateral either total hip or total knee surgery to be discharged on the day of surgery, or the next day but no later than 48 hrs following surgery. Therefore, for the patients in whom a Bridge device will be placed following surgery, it will be possible to document, if during the 120 hrs following the placement of the device, the patient returned to the hospital because of pain. This will be documented in the patient chart and therefore will be available for review.
Given that most post-bariatric patients are discharged at 72 hours or before, pain scores, opioid needs, and device tolerability at 96 and 120 hours will be collected from the patient by calling them after discharge. Participants will be called once daily up until day 5 and asked to report information. Phone calls to patients after discharge are consistent with routine clinical care. If the kidney transplant patient is discharged prior to 120 hours (5 days), they will also be called daily to record pain scores, opioid needs, and device tolerability for the time they are discharged up to 5 days post-device placement.
As stated in the protocol, each patient will be discharged according to the standard protocol defined by the surgical team. Data collected for both historical and study subjects will be the base of the standard clinical data collected for any patient undergoing surgery at UPMC SDY, UPMC Montefiore and UPMC MWH. After the patient is discharged from the hospital data related to pain, nausea and vomiting and opioid consumption will be obtained by a daily phone call.
The historical controls will include a medical chart review of patients from the Acute Perioperative Pain Service at UPMC Shadyside Hospital. Data collection includes total narcotic/non-opioid analgesic requirement, pain scores and nausea and vomiting after the surgery. Other information collected from the medical record will include age, race and medical history. Additionally, we will also collect common medical information including time to bowel movement, time to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain related issues. No Personal Health Identifiers will be collected from the historical controls.
The subjects in whom the Bridge device will be placed will receive the same standard ERAS protocol as the patients who will be used as historical control.
No power analysis will be performed. However, the tolerability of the placement of the bridge device (focus of this study) will be assessed using the pain scores.
We will record pain scores before and after the placement of the Device (prior to leaving the recovering room, and at 24, 48, 72, 96 and 120 or until discharge from the hospital) and compare it to the historical data of pain scores recorded prior to discharge from the hospital.
- Conditions
- Acute Pain, Arthropathy of Knee, Arthropathy of Hip, Pain, Postoperative, Kidney Transplant Donor, Bariatric Surgery Candidate
- Being tested
- NSS-2 Bridge
- Keywords
- Auriculotherapy, Pain Therapy
- Medical subject headings
- Acute Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSS-2 BridgeDevice
The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | NSS-2-Bridge auricular therapy will be given in addition to standard of care. Receives: Device: NSS-2 Bridge |
| Control | No intervention | No intervention, subject receives standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption
Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
Measured: This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
Secondary outcomes (7)
Pain Scores
Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative NRS Pain scores in opioid-naïve patients undergoing either a total hip or total knee arthroplasty, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital.
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.
Measured: Day of Surgery, 24 hours post-operative, 48 hours post-operative
Number of Participants With Post-operative Complications
Investigate the number of participants that experienced post-operative complications .
Measured: Day of Surgery through post-operative day 5
Level of Comfort Wearing NSS-2 Bridge Device
This was determined by asking the subject "How satisfied were you with the NSS-Bridge Device during the time in which it was worn, with 0 being the worst and 10 being the most satisfied?"
Measured: Post-operative day 5
Time to Hospital Discharge
Length of time from end of surgery to discharge from hospital
Measured: Day of Surgery to post-op day 5
Time to Discharge From Recovery Room
Length of time from end of surgery to discharge from the recovery room
Measured: Day of Surgery through post-operative day 5
Time to Oral Intake
Length of time from end of surgery to first oral intake
Measured: Day of surgery to post-op day 5
Time to Ambulation
Length of time from end of surgery to first ambulation
Measured: Day of surgery to post-op day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start8 Mar 2019
- Primary completion30 Mar 2021
- Study completion30 Jun 2021
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 Acute PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 10 subjects will be recruited in each surgical population (hip/knee, kidney, bariatric) to equal 30 total active participants. This will be compared to 10 controls in each surgical population, for a total of 60 participants in the entire pilot.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E Chelly, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834142
- Sponsor's protocol ID
- STUDY19020023
- Status last verified
- Jul 2022
- First submitted
- 6 Feb 2019
- Last updated
- 3 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Feasibility and Tolerability of the Use of NSS-2-BRIDGE Device for Post-Operative Pain in Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries
- ClinicalTrials.gov ID
- NCT03834142
- Acronym / sponsor ID
- STUDY19020023
- Conditions
- Acute Pain, Arthropathy of Knee, Arthropathy of Hip, Pain, Postoperative, Kidney Transplant Donor, Bariatric Surgery Candidate
- Keywords
- Auriculotherapy, Pain Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jacques E. ChellyUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Posted 3 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. Therefore, in order to combat this growing health crisis at the ground level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical population in order to change the incidence of post-operative opioid addiction.
Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of auricular stimulation for the perioperative management of pain in surgical patients, despite the demonstration that auriculotherapy has been shown to relieve pain in the postoperative setting.
The NSS-2- BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major orthopedic surgery such as knee and hip arthroplasties. The use of the NSS-2 BRIDGE device has been demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and clinical trials are ongoing to assess the benefit of this approach for post-operative pain management. As compared to the present use of opioids for perioperative pain management, the use of a complementary, non-pharmacologic approach offers the advantage of analgesia without the associated side effects.
Detailed description
An open-label, pilot study will investigate forty individuals, ten of which will be scheduled for total hip arthroplasty, ten will be scheduled for total knee arthroplasty, ten scheduled for kidney transplant and ten for bariatric surgery, will be approached and consented for this trial. Their data in regards to their post-operative pain, nausea, and analgesia use will be compared to 10 historic subjects who had the same surgeries in January (TKA/THA) or September (kidney transplant/bariatric) of 2019. The subjects who receive the NSS-2-BRIDGE will also be monitored for comfort with the device for the tolerability and feasibility of utilizing this device in the future to treat post-operative pain.
Once a patient has given and signed informed consent to participate in the study, demographic information and medical history will be collected from each participant on the day of the joint replacement/kidney transplant/bariatric surgery. Data will be de-identified and kept in a locked cabinet in a locked office. The PI and the research coordinator have been trained in placing the NSS-2-BRIDGE and will apply the device in the immediate post-operative setting (post-anesthesia care unit, PACU). The device will be attached behind the ear with double-sided tape. It contains three electrodes which will be applied to the ear and a ground which will be placed on the patient's lobe. Each electrode and the ground will be secured with adhesive bandages. The patient will be informed at the time of consent and after the implantation of the device that they can have the device removed any time after its application. Once the device is placed patients will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" they must pinch down on the electrodes and ground to ensure they are still placed in their designated locations and have not come loose.
As per standard of care, at 24, 48, 72, 96 and 120 hours post-operatively pain scores will be collected at rest and movement, total opioid consumption, as well as the devise tolerability. Additionally as per other pain pilot IRB approved projects, we shall also collect common medical information including time to bowel movement, PONV, time to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain related issues, quality of recovery after joint replacement, overall patient satisfaction, and patient satisfaction related to pain management.
When the patient is discharged from the hospital, they will be asked to complete a patient satisfaction survey. If the patient should be discharged prior to 120 hours post-operatively, they will be asked to wear the device home. They will also be ask to remove the device at 120 hours (five days) after device placement and dispose of it in their home. We will provide removal instructions. Data post- hospital discharge regarding pain scores, opioid consumption, and device tolerability will be collected after discharge by calling the patient every day for 120 hr. following the placement of the device.
At UPMC Shadyside, we expect the patients undergoing primary unilateral either total hip or total knee surgery to be discharged on the day of surgery, or the next day but no later than 48 hrs following surgery. Therefore, for the patients in whom a Bridge device will be placed following surgery, it will be possible to document, if during the 120 hrs following the placement of the device, the patient returned to the hospital because of pain. This will be documented in the patient chart and therefore will be available for review.
Given that most post-bariatric patients are discharged at 72 hours or before, pain scores, opioid needs, and device tolerability at 96 and 120 hours will be collected from the patient by calling them after discharge. Participants will be called once daily up until day 5 and asked to report information. Phone calls to patients after discharge are consistent with routine clinical care. If the kidney transplant patient is discharged prior to 120 hours (5 days), they will also be called daily to record pain scores, opioid needs, and device tolerability for the time they are discharged up to 5 days post-device placement.
As stated in the protocol, each patient will be discharged according to the standard protocol defined by the surgical team. Data collected for both historical and study subjects will be the base of the standard clinical data collected for any patient undergoing surgery at UPMC SDY, UPMC Montefiore and UPMC MWH. After the patient is discharged from the hospital data related to pain, nausea and vomiting and opioid consumption will be obtained by a daily phone call.
The historical controls will include a medical chart review of patients from the Acute Perioperative Pain Service at UPMC Shadyside Hospital. Data collection includes total narcotic/non-opioid analgesic requirement, pain scores and nausea and vomiting after the surgery. Other information collected from the medical record will include age, race and medical history. Additionally, we will also collect common medical information including time to bowel movement, time to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain related issues. No Personal Health Identifiers will be collected from the historical controls.
The subjects in whom the Bridge device will be placed will receive the same standard ERAS protocol as the patients who will be used as historical control.
No power analysis will be performed. However, the tolerability of the placement of the bridge device (focus of this study) will be assessed using the pain scores.
We will record pain scores before and after the placement of the Device (prior to leaving the recovering room, and at 24, 48, 72, 96 and 120 or until discharge from the hospital) and compare it to the historical data of pain scores recorded prior to discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 subjects will be recruited in each surgical population (hip/knee, kidney, bariatric) to equal 30 total active participants. This will be compared to 10 controls in each surgical population, for a total of 60 participants in the entire pilot.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: NSS-2 BridgeNSS-2-Bridge auricular therapy will be given in addition to standard of care. |
| Control | No intervention | –No intervention, subject receives standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age
- Elective Total Knee OR Total Hip Arthroplasties OR Kidney transplant surgery OR Bariatric surgery
Key exclusion criteria (7 listed)
- History of active depression, anxiety or catastrophizing
- Active alcoholism or drug abuse
- Severe chronic pain condition that requires daily preoperative opioid dependence
- History of hemophilia
- Patients with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators)
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 |
|---|---|---|
| NSS-2 BridgeThe NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. | Device | Intervention |
Primary outcome
Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption
Time frame: This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
7 secondary outcomes
Pain Scores
Time frame: Day of Surgery, 24 hours post-operative, 48 hours post-operative
Number of Participants With Post-operative Complications
Time frame: Day of Surgery through post-operative day 5
Level of Comfort Wearing NSS-2 Bridge Device
Time frame: Post-operative day 5
Time to Hospital Discharge
Time frame: Day of Surgery to post-op day 5
Time to Discharge From Recovery Room
Time frame: Day of Surgery through post-operative day 5
Time to Oral Intake
Time frame: Day of surgery to post-op day 5
Time to Ambulation
Time frame: Day of surgery to post-op day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- 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.
Jacques E Chelly, MD principal investigator
University of Pittsburgh Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSS-2 Bridge in people with Acute Pain and Arthropathy of Knee, run by Jacques E. Chelly at 3 sites 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 2 inclusion and 7 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 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 Aug 2022). 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?
Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption (time frame: This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.). 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 3 Aug 2022.