---
title: Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis
nct_id: NCT03117231
overall_status: COMPLETED
phase: NA
sponsor: Federal University of São Paulo
study_type: INTERVENTIONAL
primary_condition: Osteoarthritis, Knee
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03117231.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03117231"
ct_last_update_post_date: 2019-09-09
last_seen_at: "2026-05-12T06:24:47.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

**Official Title:** Effects of Transcranial Direct Current Stimulation (tDCS) on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory System: Protocol for a Randomized Clinical Trial

**NCT ID:** [NCT03117231](https://clinicaltrials.gov/study/NCT03117231)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 104
- **Lead Sponsor:** Federal University of São Paulo
- **Collaborators:** Spaulding Rehabilitation Hospital
- **Conditions:** Osteoarthritis, Knee, Chronic Pain
- **Start Date:** 2018-03-15
- **Completion Date:** 2019-07-01
- **CT.gov Last Update:** 2019-09-09

## Brief Summary

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.

## Eligibility

- **Minimum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## Interventions

- **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.
- **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

## Primary Outcomes

- **Changes in Pain Scale** _(time frame: Measured at baseline and up to 60 days after the end of stimulation)_ — 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)

## Secondary Outcomes

- **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** _(time frame: Measured at baseline, 15, 30, and 60 days after the end of stimulation)_
- **Changes in Patient Global Assessment** _(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** _(time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation)_
- **Adverse Events** _(time frame: Up to 60 days after the end of stimulation)_
- **Changes in Mood** _(time frame: Up to 60 days after the end of stimulation)_
- **Changes in cognition** _(time frame: Up to 60 days after the end of stimulation)_
- **One leg standing balance test** _(time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation)_
- **Timed Up and Go Test** _(time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation)_
- **Changes Pain Pressure Threshold (PPT)** _(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** _(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** _(time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation)_
- **Descending Noxious Inhibitory Control (DNIC)** _(time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation)_

## Locations (1)

- Daniela Tavares, São Paulo, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.daniela tavares|são paulo|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03117231.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03117231*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*