NCT04015323

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 4, 2019

Last Update Submit

July 20, 2020

Conditions

Knee Osteoarthritis

Keywords

interferential currentknee osteoarthritispain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    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

    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

    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

    At baseline, on the 3rd week visit (last day of interference therapy) and on the 7th week visit

Study Arms (3)

IFC Therapy 2 kHz Arm

EXPERIMENTAL

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

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

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

Device: Interferential current

Interventions

Interferential currentDEVICE

An electrotherapy current with different carrier frequencies

IFC Therapy 2 kHz ArmIFC Therapy 4 kHz ArmIFC Therapy 8 kHz Arm

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University School of Medicine

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Benil N Ata, M.D.

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Inversitagor

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 10, 2019

Study Start

July 1, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)