Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS Group | Active Comparator | Ten sessions of active conventional TENS and hydrocollator hot-pack. |
|
| Active IFC Group | Active Comparator | Ten sessions of active interferential current and hydrocollator hot-pack. |
|
| Sham TENS Group | Sham Comparator | Ten sessions of sham TENS and hydrocollator hot-pack. |
|
| Sham IFC Group | Sham Comparator | Ten sessions of sham IFC and hydrocollator hot-pack. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Device | 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Age | years | Baseline |
| Gender | female/male | Baseline |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Şahide E Almaz, MD | Contact | +905534488730 | edartuc@gmail.com | |
| Hatice Bodur, Professor | Contact | +905054848496 | haticebodur@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Şahide E Almaz, MD | Turkish League Against Rheumatism | Principal Investigator |
| Hatice Bodur, Professor | Turkish League Against Rheumatism | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital | Recruiting | Ankara | Turkey (Türkiye) |
All the collected data will be shared with investigators of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Interferential Current | Device | 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. |
|
|
| Hydrocollator hot-pack | Other | 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. |
|
| Sham transcutaneous Electrical Nerve Stimulation | Device | 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. |
|
|
| Sham interferential Current | Device | 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. |
|
|
| 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 |
| 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 Chair |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D004599 | Electric Stimulation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided