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Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

F

Federal University of São Paulo

Status

Completed

Conditions

Chronic Pain
Osteoarthritis, Knee

Treatments

Device: Active Transcranial Direct Current Stimulation (tDCS)
Device: Sham Transcranial Direct Current Stimulation (tDCS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03117231
Tavares1

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Individuals > 60 years old, of both genders.
  • 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

  • Contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

104 participants in 2 patient groups

Active tDCS
Experimental group
Description:
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Treatment:
Device: Active Transcranial Direct Current Stimulation (tDCS)
Sham tDCS
Sham Comparator group
Description:
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Treatment:
Device: Sham Transcranial Direct Current Stimulation (tDCS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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