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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04137731
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Montefiore Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zeynep Seref-Ferlengez, PhDSun Jin Kim, MD
Principal Investigator Affiliation Albert Einstein College of MedicineMontefiore Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteo Arthritis Knee
Arms & Interventions

Arms

Experimental: IFC Treatment

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

Interventions

Device: - Interferential Current Therapy

IFC treatment after Total Knee Arthroplasty

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Montefiore Medical Center, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center

Bronx, New York, 10461

Site Contact

Senior Operations Manager

[email protected]

347-577-4441