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Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty (IFC)

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interferential Current Therapy
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IFC Treatment

Placebo

Arm Description

The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty

One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.

Outcomes

Primary Outcome Measures

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).
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).
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
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

Secondary Outcome Measures

Full Information

First Posted
October 22, 2019
Last Updated
September 6, 2023
Sponsor
Montefiore Medical Center
Collaborators
Ortho IFC LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04137731
Brief Title
Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty
Acronym
IFC
Official Title
The Effect of Short Term Patient Outcomes With the Use of Interferential Current Therapy After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Ortho IFC LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IFC Treatment
Arm Type
Experimental
Arm Description
The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Intervention Type
Device
Intervention Name(s)
Interferential Current Therapy
Intervention Description
IFC treatment after Total Knee Arthroplasty
Primary Outcome Measure Information:
Title
Post-operative Opioid Pain Medication Usage
Description
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
Title
Post-operative Opioid Pain Medication Usage
Description
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
Title
Visual Pain Score (VAS)
Description
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
Title
Visual Pain Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Seref-Ferlengez, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sun Jin Kim, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty

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