Trial Outcomes & Findings for Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty (NCT NCT04137731)
NCT ID: NCT04137731
Last Updated: 2023-09-08
Results Overview
Post-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median morphine milligram equivalents (MME).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
24 hours after surgery
Results posted on
2023-09-08
Participant Flow
While forty-two (42) participants were consented, two of the consented participants never had surgery (one participant due to COVID-related restrictions and one participant on account of changing their mind) and thus were never enrolled/randomized into the study and thus 40 participants were considered to have been enrolled/randomized for purposes of analysis. Twenty into each arm/group
Participant milestones
| Measure |
IFC Treatment
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
IFC Treatment
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
|---|---|---|
|
Overall Study
Surgery Cancellation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
IFC Treatment
n=20 Participants
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
n=20 Participants
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
65.2 Years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
65.5 Years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours after surgeryPost-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median morphine milligram equivalents (MME).
Outcome measures
| Measure |
IFC Treatment
n=17 Participants
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
n=17 Participants
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
|---|---|---|
|
Post-operative Opioid Pain Medication Usage
|
24.5 MME
Interval 15.0 to 34.0
|
15.0 MME
Interval 7.5 to 17.0
|
PRIMARY outcome
Timeframe: 48 hours after surgeryPost-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median MME (morphine milligram equivalents).
Outcome measures
| Measure |
IFC Treatment
n=17 Participants
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
n=17 Participants
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
|---|---|---|
|
Post-operative Opioid Pain Medication Usage
|
60.0 MME
Interval 48.8 to 70.0
|
60.0 MME
Interval 30.0 to 85.0
|
PRIMARY outcome
Timeframe: 24 Hours after surgeryVAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face 0=No pain - sad face 10=worst pain
Outcome measures
| Measure |
IFC Treatment
n=17 Participants
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
n=17 Participants
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
|---|---|---|
|
Visual Pain Score (VAS)
|
6 score on a scale
Interval 3.0 to 7.0
|
6 score on a scale
Interval 4.0 to 8.0
|
PRIMARY outcome
Timeframe: 48 Hours after surgeryVAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face 0=No pain - sad face 10=worst pain
Outcome measures
| Measure |
IFC Treatment
n=17 Participants
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
Placebo
n=17 Participants
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
|
|---|---|---|
|
Visual Pain Score
|
5.5 score on a scale
Interval 3.75 to 7.0
|
6 score on a scale
Interval 3.25 to 7.0
|
Adverse Events
IFC Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Director
Joint Replacement Center of Montefiore Medical Center
Phone: 9292466352
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60