Knee OsteoarthritisNCT04015323
The Efficacy of Interferential Current Treatment on Knee Osteoarthritis
A study testing Interferential current in people with Knee Osteoarthritis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The effects of different carrier frequencies of interferential current on pain and function in patients with knee arthrosis will be compared Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Interferential current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50-80 years
- Knee VAS pain scores ≥ 4
- Kellgren-Lawrence radiologic scores 2 and 3
Who cannot join
- History of knee surgery
- Inflammatory arthritis
- Paralysis of lower extremities
- Serious cardiovascular disease /presence of cardiac pacemaker
- Severe osteoarhthritis of lower extremity joints other than the knees
- History of newly diagnosed cancer (ın the last 6 months)
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine
Izmir, 35100
About this study
Official title: The Efficacy of Interferential Current Treatment on Knee Osteoarthritis: A Randomized Double Blind Study That Compares the Effects of Different Carrier Frequencies
The effects of different carrier frequencies of interferential current on pain and function in patients with knee arthrosis will be compared
Read the detailed description
60 patients with knee osteoarhthritis will be enrolled in the study. Subjects will be randomized to 3 groups. All patients will receive interferential currents to both their knees, with different carrier frequencies (2, 4 and 8 kilohertz (kHz) respectively). The effect of different types of carrier frequencies on pain, 10 meter walk test will be analysed.
- Conditions
- Knee Osteoarthritis
- Being tested
- Interferential current
- Keywords
- interferential current, knee osteoarthritis, pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential currentDevice
An electrotherapy current with different carrier frequencies
| Study group | Role | What they receive |
|---|---|---|
| IFC Therapy 2 kHz Arm | Experimental | Subjects in this group will receive interferential current to their knees with a carrier frequency of 2 kHz Receives: Device: Interferential current |
| IFC Therapy 4 kHz Arm | Experimental | Subjects in this group will receive interferential current to their knees with a carrier frequency of 4 kHz Receives: Device: Interferential current |
| IFC Therapy 8 kHz Arm | Experimental | Subjects in this group will receive interferential current to their knees with a carrier frequency of 8 kHz Receives: Device: Interferential current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores according to visual analog scale (VAS)
A visual analog scale value between 0-10. 0 meaning lack of pain and 10 meaning the worst pain the patient has experienced.
Measured: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Secondary outcomes (4)
Change in functional status levels according to Western Ontario and McMaster Universities Arhtiritis Incex (WOMAC) scale
Womac scale is a questionnaire assessing patients' level of pain and functional status. Scores. Scores range from 0 to 96, 0 representing best and 96 representing worst scores. Pain, stiffness and functional limitation subscores are added up to obtain a total WOMAC score.
Measured: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Change in pain status levels according to Western Ontario and McMaster Universities Arhtiritis Incex (WOMAC) scale
Womac scale is a questionnaire assessing patients' level of pain and functional status. Scores. Scores range from 0 to 96, 0 representing best and 96 representing worst scores. Pain, stiffness and functional limitation subscores are added up to obtain a total WOMAC score.
Measured: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Change in 10 meter walking test score
This test is a measure that is used to assess walking speed in meters per second over 10 meters. It is used to determine functional mobility.
Measured: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Change in the number of paracetamol tablets taken in a week
Number of 500 mg tablets taken over one week will be written by subjects.
Measured: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benil Nesli Ata, MD, Ege University
- Investigators
- Benil N Ata, M.D., Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015323
- Sponsor's protocol ID
- 19-5.1/24
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Interferential Current Treatment on Knee Osteoarthritis: A Randomized Double Blind Study That Compares the Effects of Different Carrier Frequencies
- ClinicalTrials.gov ID
- NCT04015323
- Acronym / sponsor ID
- 19-5.1/24
- Conditions
- Knee Osteoarthritis
- Keywords
- interferential current, knee osteoarthritis, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of different carrier frequencies of interferential current on pain and function in patients with knee arthrosis will be compared
Detailed description
60 patients with knee osteoarhthritis will be enrolled in the study. Subjects will be randomized to 3 groups. All patients will receive interferential currents to both their knees, with different carrier frequencies (2, 4 and 8 kilohertz (kHz) respectively). The effect of different types of carrier frequencies on pain, 10 meter walk test will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IFC Therapy 2 kHz Arm | Experimental | Device: Interferential currentSubjects in this group will receive interferential current to their knees with a carrier frequency of 2 kHz |
| IFC Therapy 4 kHz Arm | Experimental | Device: Interferential currentSubjects in this group will receive interferential current to their knees with a carrier frequency of 4 kHz |
| IFC Therapy 8 kHz Arm | Experimental | Device: Interferential currentSubjects in this group will receive interferential current to their knees with a carrier frequency of 8 kHz |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 50-80 years
- Knee VAS pain scores ≥ 4
- Kellgren-Lawrence radiologic scores 2 and 3
Key exclusion criteria (7 listed)
- History of knee surgery
- Inflammatory arthritis
- Paralysis of lower extremities
- Serious cardiovascular disease /presence of cardiac pacemaker
- Severe osteoarhthritis of lower extremity joints other than the knees
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 currentAn electrotherapy current with different carrier frequencies | Device | IFC Therapy 2 kHz Arm, IFC Therapy 4 kHz Arm, IFC Therapy 8 kHz Arm |
Primary outcome
Change in pain scores according to visual analog scale (VAS)
Time frame: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
A visual analog scale value between 0-10. 0 meaning lack of pain and 10 meaning the worst pain the patient has experienced.
4 secondary outcomes
Change in functional status levels according to Western Ontario and McMaster Universities Arhtiritis Incex (WOMAC) scale
Time frame: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Change in pain status levels according to Western Ontario and McMaster Universities Arhtiritis Incex (WOMAC) scale
Time frame: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Change in 10 meter walking test score
Time frame: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Change in the number of paracetamol tablets taken in a week
Time frame: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- 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.
Benil N Ata, M.D. principal investigator
Ege University
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 in people with Knee Osteoarthritis, run by Ege University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 22 Jul 2020. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pain scores according to visual analog scale (VAS) (time frame: At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit). 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 22 Jul 2020.