Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

Federal University of São Paulo104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Osteoarthritis, Knee Chronic Pain

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Daniela Tavares

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Changes in Pain Scale

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)

Time frame: Measured at baseline and up to 60 days after the end of stimulation

Secondary Outcomes

Changes in Quality of Life

The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess 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

The investigators will use the Lequesne Index to assess changes in functional capacity.

Time frame: Measured at baseline, 15, 30, and 60 days after the end of stimulation

Changes in Patient Global Assessment

Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).

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

The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity.

Time frame: Measured at baseline, 15, 30 and 60 days after the end of stimulation

Adverse Events

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.

Data from ClinicalTrials.gov

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