Osteo Arthritis Knee
Conditions
Brief summary
Interferential Current Therapy (IFC) is a form of electrical therapy that utilizes two simultaneous low frequency electrical stimulation which when they cross interfere with one another resulting in an interference or beat frequency. This beat frequency provides a therapeutic area of relief by blocking painful stimuli at the area of interest. IFC is different from the other electrical treatment modalities used because the cancellation effect allows for establishment of the treatment area to be in the deeper tissues of the body, whereas other electrical modalities can only be used to treat superficial body parts that lie just under the skin. The main objective of this proposed study is to assess the post-operative short term outcomes of the patients who receive IFC treatment during their post-total knee arthroplasty (TKA) surgery hospital stay. The implications of the study would be improved patient outcome which could result in shorter hospital stay, reduced use of opioid medication, decreased need for manipulation under anesthesia and reduced re-admission rate.
Interventions
IFC treatment after Total Knee Arthroplasty
Sponsors
Ortho IFC LLC
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with knee osteoarthritis who have failed conservative therapy and undergoing elected TKA. \-
Exclusion criteria
i. \<18 years old ii. Any patient with pacemaker or any electrical stimulator device iii. Patients without capacity to consent for the study iv. Patients not able to have local nerve block or spinal anesthesia v. Patients with prior chronic opioid use vi. Patients who are categorized to have 'Severe' fear and anxiety responses to pain, according to the Pain catastrophizing scale (PCS) survey.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Pain Medication Usage | 24 hours after surgery | 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). |
| Visual Pain Score (VAS) | 24 Hours after surgery | VAS 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 |
| Visual Pain Score | 48 Hours after surgery | VAS 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 |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Surgery Cancellation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | IFC Treatment | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 65.9 Years STANDARD_DEVIATION 10.5 | 65.5 Years STANDARD_DEVIATION 9.8 | 65.2 Years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 14 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 16 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 27 Participants | 12 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 17 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Post-operative Opioid Pain Medication Usage
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).
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IFC Treatment | Post-operative Opioid Pain Medication Usage | 24.5 MME |
| Placebo | Post-operative Opioid Pain Medication Usage | 15.0 MME |
Primary
Post-operative Opioid Pain Medication Usage
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 MME (morphine milligram equivalents).
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IFC Treatment | Post-operative Opioid Pain Medication Usage | 60.0 MME |
| Placebo | Post-operative Opioid Pain Medication Usage | 60.0 MME |
Primary
Visual Pain Score
VAS 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
Time frame: 48 Hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IFC Treatment | Visual Pain Score | 5.5 score on a scale |
| Placebo | Visual Pain Score | 6 score on a scale |
Primary
Visual Pain Score (VAS)
VAS 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
Time frame: 24 Hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IFC Treatment | Visual Pain Score (VAS) | 6 score on a scale |
| Placebo | Visual Pain Score (VAS) | 6 score on a scale |