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The Efficacy of Interferential Current Treatment on Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Interferential current

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring interferential current, knee osteoarthritis, pain

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ege University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

IFC Therapy 2 kHz Arm

IFC Therapy 4 kHz Arm

IFC Therapy 8 kHz Arm

Arm Description

Subjects in this group will receive interferential current to their knees with a carrier frequency of 2 kHz

Subjects in this group will receive interferential current to their knees with a carrier frequency of 4 kHz

Subjects in this group will receive interferential current to their knees with a carrier frequency of 8 kHz

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Change in pain status levels according to Western Ontario and McMaster Universities Arhtiritis Incex (WOMAC) scale

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.

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.

Full Information

NCT ID

NCT04015323

First Posted

July 4, 2019

Last Updated

July 20, 2020

Sponsor

Ege University

1. Study Identification

Unique Protocol Identification Number

NCT04015323

Brief Title

The Efficacy of Interferential Current Treatment on Knee Osteoarthritis

Official Title

The Efficacy of Interferential Current Treatment on Knee Osteoarthritis: A Randomized Double Blind Study That Compares the Effects of Different Carrier Frequencies

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

October 1, 2019 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

interferential current, knee osteoarthritis, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IFC Therapy 2 kHz Arm

Arm Type

Experimental

Arm Description

Subjects in this group will receive interferential current to their knees with a carrier frequency of 2 kHz

Arm Title

IFC Therapy 4 kHz Arm

Arm Type

Experimental

Arm Description

Subjects in this group will receive interferential current to their knees with a carrier frequency of 4 kHz

Arm Title

IFC Therapy 8 kHz Arm

Arm Type

Experimental

Arm Description

Subjects in this group will receive interferential current to their knees with a carrier frequency of 8 kHz

Intervention Type

Device

Intervention Name(s)

Interferential current

Intervention Description

An electrotherapy current with different carrier frequencies

Primary Outcome Measure Information:

Title

Change in pain scores according to visual analog scale (VAS)

Description

A visual analog scale value between 0-10. 0 meaning lack of pain and 10 meaning the worst pain the patient has experienced.

Time Frame