An interventional study of Active Transcranial Direct Current Stimulation (tDCS) and Sham Transcranial Direct Current Stimulation (tDCS) in Osteoarthritis, Knee and Chronic Pain, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 104 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Device: Active Transcranial Direct Current Stimulation (tDCS)
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Device: 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. During active stimulation, the current will be active for the full 20 minutes.
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
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)
Time frame: Measured at baseline and up to 60 days after the end of stimulation
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.
Time frame: Measured at baseline, 15, 30 and 60 days after the of stimulation
Changes in Physical Function as measured through Lequesne Index
The investigators will use the Lequesne Index to assess changes in functional capacity.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo