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Completed

NCT Number: NCT04137731

Use of Interferential Current (IFC) 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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferential current therapy

Device

IFC treatment after Total Knee Arthroplasty

Primary outcomes

  1. Post-operative Opioid Pain Medication Usage

    Time frame: 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).

  2. Post-operative Opioid Pain Medication Usage

    Time frame: 48 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 MME (morphine milligram equivalents).

  3. Visual Pain Score (VAS)

    Time frame: 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

  4. Visual Pain Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Ortho IFC LLC

Registry information

Official study title

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

Acronym: IFC

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2019
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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