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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • 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

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
Intervention / Treatment
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

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

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

Federal University of São Paulo

Collaborators

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)

March 15, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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