Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee; Chronic Pain

• Registration Number: NCT01747070
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Study Start: 2014-03
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the pressure pain threshold.	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.
Change in the intensity of daily pain.	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.

Secondary Outcome Measures

Name	Time	Method
Level of depressive symptoms .	Depressive symptoms will be assessed before and after treatment. Totaly five days.	Depressive symptoms are measured by the Beck Depression Scale, which covers neurovegetative symptoms of depression .
Change in the level of functionality.	The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.	WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability.
State of physical and mental health.	The state of physical and mental health will be assessed before and after treatment. Totaly five days.	The quality of life and health status will be assessed through the WHOQOL ( World Health Organization Quality of Life), reduced form, adapted to Portuguese in Brazil. The level of catastrophic thinking will be assessed by the scale of catastrophic thoughts.
Daily sleep quality.	Sleep quality will be evaluated daily, totaling five days of evaluation.	Sleep quality will be assessed with the Pittsburgh Sleep Quality Index and the 10cm scale of sleep quality.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil