Osteoarthritis, Knee
Conditions
Keywords
Physical therapy modalities, Osteoarthritis knee, Central nervous system sensitization, Pain, Electric Stimulation Therapy
Brief 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).
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.
Interventions
DEVICETranscutaneous 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.
DEVICEInterferential 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.
OTHERHydrocollator 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.
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.
Sponsors
Turkish League Against Rheumatism
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure-pain thresholds | Change from baseline pressure-pain thresholds at 2 weeks and at 12 weeks | 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. |
| Tampa Scale of Kinesiophobia | Change from baseline kinesiophobia scores at 2 weeks and at 12 weeks | 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. |
| Beck Depression Inventory (BDI) | Change from baseline BDI scores at 2 weeks and at 12 weeks. | Beck Depression Inventory is a 21-item questionnaire that examines the characteristic symptoms of depression. |
| Pain catastrophizing scale (PCS) | Change from baseline PCS scores at 2 weeks and at 12 weeks. | PCS consists of 13 items in three subscales (rumination, helplessness, and magnification). Higher final score indicates more catastrophic thinking related to pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comorbidity | Baseline | self reported |
| Visual analogue scale (VAS) | Change from baseline, at 2 weeks and at 12 weeks | VAS ranging levels from 0 (no pain) to 10 (maximal pain). |
| Age | Baseline | years |
| Timed Up and Go Test (TUG) | Change from baseline, at 2 weeks and at 12 weeks | 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. |
| Five Times Sit to Stand Test | Change from baseline, at 2 weeks and at 12 weeks | 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. |
| Western Ontario and McMaster University (WOMAC) Index. | Change from baseline, at 2 weeks and at 12 weeks | 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. |
| Gender | Baseline | female/male |
| Height | Baseline | centimeter (cm) |
| Weight | Baseline | kilogram (kg) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactŞahide E Almaz, MD
Backup ContactHatice Bodur, Professor
Outcome results
None listed