Osteo Arthritis KneeIFCNCT04137731
Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty
A study testing Interferential Current Therapy in people with Osteo Arthritis Knee, run by Montefiore Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Interferential Current Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2019to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- <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 locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Interferential Current Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential Current TherapyDevice
IFC treatment after Total Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| IFC Treatment | Experimental | The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty Receives: 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. Receives: Device: Interferential Current Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 48 Hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start5 Dec 2019
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho IFC LLC
- Responsible party
- Sponsor
- Investigators
- Zeynep Seref-Ferlengez, PhD, Principal investigator, Albert Einstein College of MedicineSun Jin Kim, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137731
- Sponsor's protocol ID
- 2019-10138
- Other IDs
- 2019
- Acronym
- IFC
- Status last verified
- Sep 2023
- First submitted
- 22 Oct 2019
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short Term Patient Outcomes With the Use of Interferential Current Therapy After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04137731
- Acronym / sponsor ID
- IFC / 2019-10138
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Ortho IFC LLC
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFC Treatment | Experimental | Device: Interferential Current TherapyThe IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty |
| Placebo | Placebo comparator | Device: Interferential Current TherapyOne set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferential Current TherapyIFC treatment after Total Knee Arthroplasty | Device | IFC Treatment, Placebo |
Primary outcome
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).
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).
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Seref-Ferlengez, PhD principal investigator
Albert Einstein College of Medicine
Sun Jin Kim, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferential Current Therapy in people with Osteo Arthritis Knee, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Opioid Pain Medication Usage (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.