Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

Summary

The aim of this study is to compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential currents (IFCs) and sham devices in improving central sensitization (CS) findings, including pressure pain thresholds, pain catastrophizing, depression, and kinesiophobia in patients with knee osteoarthritis (OA).

Conditions

• Osteoarthritis, Knee

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation

Electrodes are placed around painful regions determined by the patient as patients are in the sitting position with the knees extended. The device is set at pulse duration of 50 to 80 μs; pulse frequency of 50 to 100 Hz; low-intensity (paraesthesia, not painful). The patient wears TENS for a 20-minute duration for each knee.

DEVICE

Interferential Current

Electrodes are placed diagonally around the painful areas defined by the patient, with the patient in the sitting position with the knees extended. The device is set at carrier frequency 4000 Hz, amplitude modulated frequency (AMF) 100 Hz, scanning frequency 50 Hz, scanning mode 1: 1 s. The patient wears ICF for a 20-minute duration for each knee.

OTHER

Hydrocollator hot-pack

The hot-pack (at a surface temperature of almost 42 °C) is administered on knees while patients are in sitting position with the knees extended. Every session includes 20 minutes of hot-pack for each knee.

DEVICE

Sham transcutaneous Electrical Nerve Stimulation

Electrodes are placed around painful regions determined by the patient as patients are in the sitting position with the knees extended.TENS unit in place but not turned on.The patient wears TENS for a 20-minute duration for each knee.

DEVICE

Sham interferential Current

Electrodes are placed diagonally around the painful areas defined by the patient, with the patient in the sitting position with the knees extended. IFC unit in place but not turned on.The patient wears ICF for a 20-minute duration for each knee.

Sponsors & Collaborators

• Turkish League Against Rheumatism

  lead OTHER

Principal Investigators

• Şahide E Almaz, MD · Turkish League Against Rheumatism

• Hatice Bodur, Professor · Turkish League Against Rheumatism

• Aslı Çalışkan Uçkun, MD · Turkish League Against Rheumatism

• Filiz Acar Sivas, Professor · Turkish League Against Rheumatism

• Fatma G Yurdakul, MD · Turkish League Against Rheumatism

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2020-02-01

Completion

2020-02-01

FDA Device

Yes

Countries

• Turkey (Türkiye)

Study Locations