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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04015323
Other study ID # 19-5.1/24
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date December 1, 2019

Study information

Verified date July 2020
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effects of different carrier frequencies of interferential current on pain and function in patients with knee arthrosis will be compared


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 (in the last 6 months)

- Cognitive impairment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Interferential current
An electrotherapy current with different carrier frequencies

Locations

Country Name City State
Turkey Ege University School of Medicine Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Secondary 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. At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Secondary 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. At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Secondary 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. At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
Secondary 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. At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit
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