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

NCT04137731 | Completed Results DMC FDA Device

• 1 other identifier: 2019-10138
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

IFC Treatment

EXPERIMENTAL

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

Device: Interferential Current Therapy

Placebo

PLACEBO COMPARATOR

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

Interventions

Interferential Current Therapy DEVICE

IFC treatment after Total Knee Arthroplasty

IFC Treatment; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Ortho IFC LLC: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Clinical Research Director
• Organization: Joint Replacement Center of Montefiore Medical Center

sereffer@montefiore.org

9292466352

Study Officials

• Zeynep Seref-Ferlengez, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Sun Jin Kim, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: December 5, 2019
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)