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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137731
Other study ID # 2019-10138
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2019
Est. completion date August 15, 2022

Study information

Verified date September 2023
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Interferential Current Therapy
IFC treatment after Total Knee Arthroplasty

Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (2)

Lead Sponsor Collaborator
Montefiore Medical Center Ortho IFC LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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