Trial Outcomes & Findings for NEUROCUPLE™ in TKA Patients to Enhance Pain Management (NCT NCT06460350)
NCT ID: NCT06460350
Last Updated: 2026-06-04
Results Overview
Pain at rest will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
1-Week Post Hospital Discharge
Results posted on
2026-06-04
Participant Flow
Participant milestones
| Measure |
NEUROCUPLE™ Group
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
77
|
|
Overall Study
COMPLETED
|
74
|
69
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NEUROCUPLE™ in TKA Patients to Enhance Pain Management
Baseline characteristics by cohort
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=9 Participants
|
69 Participants
n=27 Participants
|
143 Participants
n=267 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
58 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=9 Participants
|
50 Participants
n=27 Participants
|
98 Participants
n=267 Participants
|
|
Age, Continuous
|
65.3 years
n=9 Participants
|
67.1 years
n=27 Participants
|
66.2 years
n=267 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=9 Participants
|
45 Participants
n=27 Participants
|
82 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=9 Participants
|
32 Participants
n=27 Participants
|
74 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=9 Participants
|
77 participants
n=27 Participants
|
156 participants
n=267 Participants
|
|
BMI
|
32.9 kg/m^2
n=9 Participants
|
30.8 kg/m^2
n=27 Participants
|
31.9 kg/m^2
n=267 Participants
|
PRIMARY outcome
Timeframe: 1-Week Post Hospital DischargePain at rest will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Post-operative Pain at Rest
|
3.5 score on a scale
Interval 0.0 to 8.3
|
4.1 score on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 24-hours post-operativelyIncidence of PONV measured by antiemetic use yes/no
Outcome measures
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Number of Participants With Post-Operative Nausea and Vomiting (PONV) and Antiemetic Use
At least one episode of PONV
|
14 Participants
|
21 Participants
|
|
Number of Participants With Post-Operative Nausea and Vomiting (PONV) and Antiemetic Use
At least one antiemetic used
|
13 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to post-operative day 10The length of the hospital stay will be abstracted from the medical records, and the mean time and full range will be reported in hours
Outcome measures
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Time to Hospital Discharge (Length of Hospital Stay)
|
20.8 hours
Interval 3.2 to 219.0
|
25.7 hours
Interval 3.8 to 99.4
|
SECONDARY outcome
Timeframe: Up to 24-hours post-operativelyOME measured in mg
Outcome measures
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Total Opioid Use in OME (mg) (in Hospital)
|
25.6 Morphine Milligram Equivalent (mg)
Interval 0.0 to 103.8
|
34.4 Morphine Milligram Equivalent (mg)
Interval 0.0 to 106.2
|
SECONDARY outcome
Timeframe: One-week Post Hospital DischargeOME measured in mg
Outcome measures
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Total Opioid Use in OME (mg) at 1 Week Post-Hospital Discharge
|
16.1 Morphine Milligram Equivalent (mg)
Interval 0.0 to 60.0
|
20.0 Morphine Milligram Equivalent (mg)
Interval 0.0 to 90.0
|
SECONDARY outcome
Timeframe: Up to 24-hours post-operativelyAssessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
| Measure |
NEUROCUPLE™ Group
n=79 Participants
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 Participants
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Post-Operative Pain Scores (NRS)
|
4.3 score on a scale
Interval 0.0 to 7.8
|
4.9 score on a scale
Interval 0.8 to 7.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to day of surgeryPain at rest will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to day of surgeryPain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-Week Post Hospital DischargePain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-Weeks Post Hospital DischargePain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to day of surgeryPain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-Weeks Post Hospital DischargePain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1-Week Post Hospital DischargePain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-Weeks Post Hospital DischargePain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-Weeks Post Hospital DischargePain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-Weeks Post Hospital DischargeThe number of opioid refills will be collected via Prescription Drug Monitoring Program (PDMP) for up to 6-weeks following hospital discharge. This will be averaged across each group and reported as a Mean(SD).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-Weeks and 6-Weeks Post Hospital DischargeScale from 0 (least satisfied) to 10 (most satisfied)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-Weeks and 6-Weeks Post Hospital DischargeScale from 0 (least satisfied) to 10 (most satisfied)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-hours post-operativelyPain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-hours post-operativelyPain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable
Outcome measures
Outcome data not reported
Adverse Events
NEUROCUPLE™ Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NEUROCUPLE™ Group
n=79 participants at risk
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
NEUROCUPLE™ Patch: nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
|
Placebo Group
n=77 participants at risk
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Placebo Patch: The placebo patch is identical to the active patch but with no active agents.
|
|---|---|---|
|
Surgical and medical procedures
Bleeding at implantation site
|
1.3%
1/79 • Number of events 1 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
0.00%
0/77 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
3.8%
3/79 • Number of events 3 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
0.00%
0/77 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
|
Product Issues
Discomfort wearing the device
|
1.3%
1/79 • Number of events 1 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
5.2%
4/77 • Number of events 4 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
|
Product Issues
Compression
|
5.1%
4/79 • Number of events 4 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
2.6%
2/77 • Number of events 2 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
|
Skin and subcutaneous tissue disorders
Rash at site of band
|
1.3%
1/79 • Number of events 1 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
0.00%
0/77 • Adverse events were assessed from the time the device was placed on day of surgery through study completion (30 days from device placement)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place