An interventional study of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Osteoarthritis, Knee, sponsored by Turkish League Against Rheumatism. Status unknown at 1 site in Turkey. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-06.
Sponsored by Turkish League Against Rheumatism · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Turkish League Against Rheumatism is the lead sponsor of 7 studies on the registry; none are open to participants now.
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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:
Ten sessions of active conventional TENS and hydrocollator hot-pack.
Device: Transcutaneous Electrical Nerve Stimulation · Other: Hydrocollator hot-pack
Ten sessions of active interferential current and hydrocollator hot-pack.
Device: Interferential Current · Other: Hydrocollator hot-pack
Ten sessions of sham TENS and hydrocollator hot-pack.
Other: Hydrocollator hot-pack · Device: Sham transcutaneous Electrical Nerve Stimulation
Ten sessions of sham IFC and hydrocollator hot-pack.
Other: Hydrocollator hot-pack · Device: Sham interferential Current
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.
Also known as: TENS
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.
Also known as: IFC
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.
Also known as: Sham TENS
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.
Also known as: Sham IFC
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.
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)
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
Plan to share: Yes — All the collected data will be shared with investigators of the study.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Turkish League Against Rheumatism