Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

NCT ID: NCT03117231

Last Updated: 2019-09-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active tDCS

Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.

Group Type EXPERIMENTAL

Active Transcranial Direct Current Stimulation (tDCS)

Intervention Type 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 tDCS

Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.

Group Type SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Type 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

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.

Intervention Type 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. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spaulding Rehabilitation Hospital

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Daniela Regina Brandão Tavares

Geriatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Daniela Tavares

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

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.

Reference Type DERIVED
PMID: 33684598 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30373731 (View on PubMed)

Other Identifiers

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Tavares1

Identifier Type: -

Identifier Source: org_study_id

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