Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153825
• Other study ID #: TRASD1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2019
• Source: Turkish League Against Rheumatism
• Contact: Sahide E Almaz, MD
• Phone: +905534488730
• Email: edartuc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

40 to 75 years of age, Having bilateral knee OA radiologically with a Kellgren-Lawrence grade of 2 or 3.

Reporting knee pain of more than 3 on the visual analog scale (VAS) over the last 6 months Being unfamiliar with TENS and IFC use

-

Exclusion Criteria:

1. Having the history of any contraindication for electrotherapy (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy),

2. Having a knee surgery or intra-articular corticosteroid or hyaluronic acid injection within 6 months.

3. Taking any drugs acting on the nervous system such as anticonvulsants, antidepressants, myorelaxants, or opioid drugs in the study period.

4. Having fibromyalgia, inflammatory rheumatologic, severe psychological disorders -

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkish League Against Rheumatism

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure-pain thresholds	Pressure pain thresholds is measured on the knee (M. Vastus Medialis) and on the upper part of the homolateral arm (lateral part of M. Deltoideus, 10 cm below acromion) using a pressure algometer. The pressure is raised at a rate of almost 1 kg/s, until the patient first notifies that the pressure sensation changes to a pain sensation.	Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks
Primary	Tampa Scale of Kinesiophobia	Tampa Scale contains 17 parts that measure anxiety and fear related to movement. The total score ranges between 17-68 points. Higher scores represent higher grades of kinesiophobia.	Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks
Primary	Beck Depression Inventory (BDI)	Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression.	Change from baseline BDI scores at 2 weeks and at 12 weeks.
Primary	Pain catastrophizing scale (PCS)	PCS consists of 13 items in three subscales (rumination, helplessness, and magnification). Higher final score indicates more catastrophic thinking related to pain.	Change from baseline PCS scores at 2 weeks and at 12 weeks.
Secondary	Age	years	Baseline
Secondary	Gender	female/male	Baseline
Secondary	Height	centimeter (cm)	Baseline
Secondary	Weight	kilogram (kg)	Baseline
Secondary	Comorbidity	self reported	Baseline
Secondary	Visual analogue scale (VAS)	VAS ranging levels from 0 (no pain) to 10 (maximal pain).	Change from baseline, at 2 weeks and at 12 weeks
Secondary	Western Ontario and McMaster University (WOMAC) Index.	There are three subscales with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.; Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.	Change from baseline, at 2 weeks and at 12 weeks
Secondary	Timed Up and Go Test (TUG)	Timed up and go test is used to assess mobility which recorded the time of rising from a back-rest chair, walking at a normal pace 3 meters, turning, walking back to the chair, and sitting recumbently. In one minute durations, each participant will perform the test three times and this time will be recorded in seconds.	Change from baseline, at 2 weeks and at 12 weeks
Secondary	Five Times Sit to Stand Test	The participant is asked to sit-to-stand action from a standard chair five times as quickly as possible, and the time taken to complete is recorded.	Change from baseline, at 2 weeks and at 12 weeks