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| Name | Class |
|---|---|
| Spaulding Rehabilitation Hospital | OTHER |
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The purpose of this study is to evaluate if anodal tDCS stimulation over M1 may decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will help to investigate the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes. |
|
| Sham tDCS | Sham Comparator | Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial Direct Current Stimulation (tDCS) | Device | Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. During active stimulation, the current will be active for the full 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Scale | Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic pain due to knee osteoarthritis, as measured by changes in the Brief Pain Inventory (BPI) | Measured at baseline and up to 60 days after the end of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life | The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess changes in quality of life. | Measured at baseline, 15, 30 and 60 days after the of stimulation |
| Changes in Physical Function as measured through Lequesne Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniela Tavares | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33684598 | Derived | Tavares DRB, Okazaki JEF, Santana MVA, Pinto ACPN, Tutiya KK, Gazoni FM, Pinto CB, Santos FC, Fregni F, Trevisani VFM. Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial. Brain Stimul. 2021 May-Jun;14(3):477-487. doi: 10.1016/j.brs.2021.02.018. Epub 2021 Mar 5. | |
| 30373731 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D059350 | Chronic Pain |
| D010003 | Osteoarthritis |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Sham Transcranial Direct Current Stimulation (tDCS) | Device | Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes |
|
The investigators will use the Lequesne Index to assess changes in functional capacity. |
| Measured at baseline, 15, 30, and 60 days after the end of stimulation |
| Changes in Patient Global Assessment | Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS). | Measured at baseline, 15, 30 and 60 after the end of stimulation |
| Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index | The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Adverse Events | Subjects will complete a questionnaire, after each session, to assess potential adverse events of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. | Up to 60 days after the end of stimulation |
| Changes in Mood | The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale. | Up to 60 days after the end of stimulation |
| Changes in cognition | The safety of tDCS will be monitored by measuring changes in the MMSE. | Up to 60 days after the end of stimulation |
| One leg standing balance test | The investigators will analyse how long time the subject can stay stand on one foot to analise those balance. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Timed Up and Go Test | The investigators will measure the walking speed of the subjects. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Changes Pain Pressure Threshold (PPT) | Changes in the pain pressure threshold will be analyzed in order to determine whether anodal transcranial direct current stimulation is effective in increasing the pain pressure threshold in subjects with osteoarthritis knee pain. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Changes in mechanical detection threshold as measured through Von-Frey monofilaments | Changes in the mechanical detection threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical detection threshold of subjects with osteoarthritis knee pain. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Changes in mechanical pain threshold as measured through Von-Frey monofilaments | Changes in the mechanical pain threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical pain threshold of subjects with osteoarthritis knee pain. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Descending Noxious Inhibitory Control (DNIC) | The investigators will monitore the central modulation of pain. | Measured at baseline, 15, 30 and 60 days after the end of stimulation |
| Derived |
| Tavares DRB, Okazaki JEF, Rocha AP, Santana MVA, Pinto ACPN, Civile VT, Santos FC, Fregni F, Trevisani VFM. Effects of Transcranial Direct Current Stimulation on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory Systems: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 29;7(10):e11660. doi: 10.2196/11660. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |