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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
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.
Ankara City Hospital
Ankara, Turkey (Türkiye)
RECRUITINGPressure-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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline PCS scores at 2 weeks and at 12 weeks.
Age
years
Time frame: Baseline
Gender
female/male
Time frame: Baseline
Height
centimeter (cm)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
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.
Time frame: Baseline
Weight
kilogram (kg)
Time frame: Baseline
Comorbidity
self reported
Time frame: Baseline
Visual analogue scale (VAS)
VAS ranging levels from 0 (no pain) to 10 (maximal pain).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline, at 2 weeks and at 12 weeks