The Efficacy of Interferential Current Treatment on Knee Osteoarthritis

July 20, 2020 updated by: Benil Nesli Ata, MD, Ege University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35100
        • Ege University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 50-80 years
  • Knee VAS pain scores ≥ 4
  • Kellgren-Lawrence radiologic scores 2 and 3

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IFC Therapy 2 kHz Arm
Subjects in this group will receive interferential current to their knees with a carrier frequency of 2 kHz
Device: Interferential current
An electrotherapy current with different carrier frequencies
EXPERIMENTAL: IFC Therapy 4 kHz Arm
Subjects in this group will receive interferential current to their knees with a carrier frequency of 4 kHz
Device: Interferential current
An electrotherapy current with different carrier frequencies
EXPERIMENTAL: IFC Therapy 8 kHz Arm
Subjects in this group will receive interferential current to their knees with a carrier frequency of 8 kHz
Device: Interferential current
An electrotherapy current with different carrier frequencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
Number of 500 mg tablets taken over one week will be written by subjects.
At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Benil N Ata, M.D., Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (ACTUAL)

July 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-5.1/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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