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Clinical Trials/NCT01747070
NCT01747070
Completed
Not Applicable

Effect of Transcranial Direct Current Stimulation and Electro Acupuncture in Pain, Functional Capability and Cortical Excitability in Patients With Osteoarthritis.

Hospital de Clinicas de Porto Alegre1 site in 1 country60 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
60
Locations
1
Primary Endpoint
Change in the intensity of daily pain.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The objective of this study is to evaluate the efficacy of transcranial direct current stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing pain, improving functional capacity and functioning of the neuro-immune-endocrine system in patients with chronic pain due to knee osteoarthritis.

Detailed Description

The knee osteoarthritis has high prevalence, which tends to increase with the aging population. The limited efficacy of pharmacological interventions stimulates the search for other options, in order to increase the therapeutic success. Acupuncture is widely used for pain control in several pathologies. A modality of intramuscular stimulation to quantify the intensity of the stimulus is electro acupuncture (EAC) that the intensity of 2 Hz accelerates the release of enkephalins, endorphins and beta-endorphins. The application of electric currents to modify brain function is a very old technique. The transcranial direct current stimulation (tDCS) is based on applying transcranial direct weak current (usually above 2mA) through electrodes in a non-invasive, simple and painless. Other advantages include low cost and the possibility of a placebo reliable. The purpose of this study is to evaluate the ability to reduce pain and improve functionality in chronic pain for knee osteoarthritis with two techniques, one that promotes a bottom-up approach (EAC) and other top-down (tDCS). We will seek to analyze the efficacy of them separately and together, seeking summation of results.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Provision of informed consent to participate.
  • Women with over 18 years old,with chronic pain because of primary osteoarthritis of the knee.
  • Pain stable for at least three months. Score greater than or equal to 3 cm (0 cm = "no pain" and "worst possible pain" = 10cm) on Visual Analog Scale (VAS) for pain perception at baseline.
  • No contraindications to electroacupuncture, transcranial direct current stimulation or transcranial magnetic stimulation.

Exclusion Criteria

  • Clinically significant or unstable disorder, medical or psychiatric.
  • Presence of neurological or rheumatic comorbidity.
  • Pregnancy.
  • Already having been treated with acupuncture.
  • Having performed with corticosteroid infiltration in the last six weeks or are using this.
  • Having performed with hyaluronic acid infiltration in the last year.
  • Previous surgery on the limb to be treated or have surgical program for the next 6 months.

Outcomes

Primary Outcomes

Change in the intensity of daily pain.

Time Frame: The treatment will be 5 daily sessions.The pain level will be assessed before treatment, after each session and at the end of treatment.Totaling six days.

Measurement of outcomes by clinical parameters: Pain - The pain daily, in the course of treatment will be measured by the Visual Analog Scale, (VAS) 10 cm where zero corresponds to no pain and 10 cm maximum pain.

Change in the pressure pain threshold.

Time Frame: The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.

Measurement of outcomes by parameters of pain threshold: Threshold Tolerance Test Algometry Pressure: the tolerance threshold pressure is measured by pressure algometer digital, with an area of 1 cm2 in area with muscle trigger point that triggers more pain. The maximum pressure to be applied will be 1400 kPa (Kilopascal) to avoid tissue damage. The patient will be instructed to indicate when the stimulus becomes unbearable and the value of tolerance threshold will be constituted by the average of three measurements.

Secondary Outcomes

  • State of physical and mental health.(The state of physical and mental health will be assessed before and after treatment. Totaly five days.)
  • Daily sleep quality.(Sleep quality will be evaluated daily, totaling five days of evaluation.)
  • Level of depressive symptoms .(Depressive symptoms will be assessed before and after treatment. Totaly five days.)
  • Change in the level of functionality.(The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.)

Study Sites (1)

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