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

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).

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation; Other: Hydrocollator hot-pack; Device: Interferential Current; Device: Sham transcutaneous Electrical Nerve Stimulation; Device: Sham interferential Current

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara City Hospital
    • Contact: Şahide E Almaz, MD; Phone Number: +905534488730; Email: edartuc@gmail.com
    • Contact: Hatice Bodur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active TENS Group; Ten sessions of active conventional TENS and hydrocollator hot-pack.	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.; Other Names: TENS; 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.
Active Comparator: Active IFC Group; Ten sessions of active interferential current and hydrocollator hot-pack.	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: 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 Names: IFC
Sham Comparator: Sham TENS Group; Ten sessions of sham TENS and hydrocollator hot-pack.	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.; Other Names: Sham TENS
Sham Comparator: Sham IFC Group; Ten sessions of sham IFC and hydrocollator hot-pack.	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 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.; Other Names: Sham IFC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	years	Baseline
Gender	female/male	Baseline
Height	centimeter (cm)	Baseline
Weight	kilogram (kg)	Baseline
Comorbidity	self reported	Baseline
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
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
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
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

Collaborators and Investigators

• Sponsor: Turkish League Against Rheumatism
• Investigators: Principal Investigator: Şahide E Almaz, MD, Turkish League Against Rheumatism; Study Director: Hatice Bodur, Professor, Turkish League Against Rheumatism; Study Chair: Aslı Çalışkan Uçkun, MD, Turkish League Against Rheumatism; Study Chair: Filiz Acar Sivas, Professor, Turkish League Against Rheumatism; Study Chair: Fatma G Yurdakul, MD, Turkish League Against Rheumatism

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Electric Stimulation Therapy; Physical therapy modalities; Osteoarthritis knee; Central nervous system sensitization
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TRASD1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All the collected data will be shared with investigators of the study.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes