NCT04153825

Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Currents (IFC) on Central Sensitization in Patients With Knee Osteoarthritis: Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Turkish League Against Rheumatism · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Knee OA, which is the most frequently encountered type of OA is a leading cause of disability and chronic pain. CS is as important as nociceptive component in the pathogenesis of OA-related pain. Therefore, the necessary interventions for CS should be also considered when deciding the treatment protocol.TENS and IFC have been safely and commonly employed in the conservative treatment of knee OA. However, there are limited and inconsistent data concerning the impact of these modalities on CS component of pain.Therefore, the aim of this study is to investigate whether these agents are effective on CS and they are superior to each other.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-11-06
• Last updated: 2019-11-06

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study