Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Transcutaneous Electrical Nerve Stimulation
* Device: Interferential Current
* Other: Hydrocollator hot-pack
* Device: Sham transcutaneous Electrical Nerve Stimulation
* Device: Sham interferential Current


Participation Criteria
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Eligibility Criteria
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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: Having the history of any contraindication for electrotherapy (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy), Having a knee surgery or intra-articular corticosteroid or hyaluronic acid injection within 6 months. Taking any drugs acting on the nervous system such as anticonvulsants, antidepressants, myorelaxants, or opioid drugs in the study period. Having fibromyalgia, inflammatory rheumatologic, severe psychological disorders -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TENS Group<br>Ten sessions of active conventional TENS and hydrocollator hot-pack. | Device: Transcutaneous Electrical Nerve Stimulation<br>* 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.<br>* Other names: TENS;Other: Hydrocollator hot-pack<br>* 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.<br>|
| Active Comparator: Active IFC Group<br>Ten sessions of active interferential current and hydrocollator hot-pack. | Device: Interferential Current<br>* 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.<br>* Other names: IFC;Other: Hydrocollator hot-pack<br>* 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.<br>|
| Sham Comparator: Sham TENS Group<br>Ten sessions of sham TENS and hydrocollator hot-pack. | Other: Hydrocollator hot-pack<br>* 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.<br>Device: Sham transcutaneous Electrical Nerve Stimulation<br>* 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.<br>* Other names: Sham TENS;|
| Sham Comparator: Sham IFC Group<br>Ten sessions of sham IFC and hydrocollator hot-pack. | Other: Hydrocollator hot-pack<br>* 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.<br>Device: Sham interferential Current<br>* 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.<br>* Other names: Sham IFC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical therapy modalities, Osteoarthritis knee, Central nervous system sensitization, Pain, Electric Stimulation Therapy