Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

September 6, 2019 updated by: Daniela Regina Brandão Tavares, Federal University of São Paulo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Daniela Tavares

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active tDCS
Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.
Device: 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 Comparator: Sham 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. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Measured at baseline and up to 60 days after the end of stimulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Quality of Life
Time Frame: Measured at baseline, 15, 30 and 60 days after the of stimulation
The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess changes in quality of life.
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
The investigators will use the Lequesne Index to assess changes in functional capacity.
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
Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).
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
The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity.
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
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.
Up to 60 days after the end of stimulation
Changes in Mood
Time Frame: Up to 60 days after the end of stimulation
The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale.
Up to 60 days after the end of stimulation
Changes in cognition
Time Frame: Up to 60 days after the end of stimulation
The safety of tDCS will be monitored by measuring changes in the MMSE.
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
The investigators will analyse how long time the subject can stay stand on one foot to analise those balance.
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
The investigators will measure the walking speed of the subjects.
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 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.
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 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.
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
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.
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
The investigators will monitore the central modulation of pain.
Measured at baseline, 15, 30 and 60 days after the end of stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tavares1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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