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

The Effect of Short Term Patient Outcomes With the Use of Interferential Current Therapy After Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: Interferential Current Therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Adult patients with knee osteoarthritis who have failed conservative therapy and undergoing elected TKA.

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IFC Treatment; The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty	Device: Interferential Current Therapy; IFC treatment after Total Knee Arthroplasty
Placebo Comparator: 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.	Device: Interferential Current Therapy; IFC treatment after Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours after surgery
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).	48 hours after surgery
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	24 Hours after surgery
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	48 Hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range of Motion	The movement of knee joint, 0: fully straight - 135 : fully bent	48 hours after surgery
Activity Measure for Post Acute Care (AM-PAC) "6-Clicks" Basic Mobility Inpatient Short Form-Scores	Patient Reported Outcome Tool used by physical therapist to asses patient's function	48 hours after surgery
Visual Pain Score (VAS)	VAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face =No pain - sad face =worst pain	24 Hours after surgery
Visual Pain Score	VAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face =No pain - sad face =worst pain	48 Hours after surgery

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Ortho IFC LLC
• Investigators: Principal Investigator: Zeynep Seref-Ferlengez, PhD, Albert Einstein College of Medicine; Principal Investigator: Sun Jin Kim, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2019-10138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes