Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis
NCT ID: NCT03117231
Last Updated: 2019-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2018-03-15
2019-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active tDCS
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Active Transcranial Direct Current Stimulation (tDCS)
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.
Sham tDCS
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Sham Transcranial Direct Current Stimulation (tDCS)
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
Interventions
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Active Transcranial Direct Current Stimulation (tDCS)
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.
Sham Transcranial Direct Current Stimulation (tDCS)
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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary knee osteoarthritis with chronic pain self-reported.
* Be able to sign the informed consent to participate in the study.
* Chronic pain (over the past 6 months) of at least 4 on a 0-10 VAS scale on average.
* Reduction on VAS (visual analogic scale) during CPM (conditioned pain modulation) \< 10%
Exclusion Criteria
* Severe acute or chronic decompensated disease.
* Cognitive and behavioral impairment.
* Epilepsy.
* History of fractures in the lower limbs and/or spine in the last 6 months.
* Use of carbamazepine within the past 6 months as self-reported.
* Severe depression (with a score of \>30 in the Beck Depression Inventory)
* History of syncope.
* Traumatic brain injury with residual neurological deficits.
* History of alcohol abuse within the past 6 months as self-reported.
60 Years
ALL
No
Sponsors
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Spaulding Rehabilitation Hospital
OTHER
Federal University of São Paulo
OTHER
Responsible Party
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Daniela Regina Brandão Tavares
Geriatrician
Locations
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Daniela Tavares
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
Other Identifiers
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Tavares1
Identifier Type: -
Identifier Source: org_study_id
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