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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee, Chronic Pain

Intervention / Treatment
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* Other: tDCS and EAC sham
* Other: tDCS sham and EAC sham
* Other: tDCS sham and EAC
* Other: tDCS and EAC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDCS and EAC sham<br>Subjects will receive 05 sessions of tDCS. The tDCS consist of application of current of 2 mA, the anode being placed in the motor cortex (M1) and the cathode in the supraorbital region, for 30 minutes,using electrodes with saline solution. The sham DIMST consist of the use of rubber electrodes placed in the same places that active treatment. Will use the same electrical apparatus, but without pass of current to the electrodes. The unit will be in front of the patient on with their lights blinking. | Other: tDCS and EAC sham<br>* The tDCS apparatus is operated on battery power, will be used rubber electrodes soaked in saline solution. The anode is placed in M1 and the cathode in the supraorbital region.<br>* Other names: Transcranial direct current stimulation.;|
| Placebo Comparator: tDCS sham and EAC sham<br>The subjects will receive 05 sessions of tDCS sham and EAC sham. The sham tDCS be performed in the same way as the active, although the Electro device is turned off 30 seconds after the beginning of treatment, the session will have the same duration of 30 minutes. The EAC sham consists of placement of rubber electrodes in the same areas of active stimulation (beside the spinous processes of L1 to S2, muscles vastus lateralis, rectus anterioris, vastus medialis, tibialis anterior, peroneus longus and insertion of the pes anserinus). The electrodes are connected to the same device electro, for 30 minutes, but without passage of electrical stimulation to the patient. The device is kept on and in front of the patient, with the lights blinking. | Other: tDCS sham and EAC sham<br>* For the EAC sham we will use rubber electrodes. They will be applied in the same areas of active EAC. They are connected to the same electroacupuncture device, but without current passing for the patient. All subjects receive one 30min session.<br>* Other names: DIMST: deep intramuscular stimulation.;|
| Active Comparator: tDCS sham and EAC<br>Subjects will receive 05 sessions of tDCS sham and EAC.The sham tDCS be performed in the same way as the active, although the Electro device is turned off 30 seconds after the beginning of treatment, the session will have the same duration of 30 minutes. The EAC consist of electrical stimulation with a frequency of 2 Hz for 30 min. The needles are placed beside the spinous processes of L1 to S2, with a depth of 3 cm and in the muscles: vastus lateralis, rectus anterioris, vastus medialis, tibialis anterior, peroneus longus and insertion of the pes anserinus. | Other: tDCS sham and EAC<br>* For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.<br>* Other names: DIMST;|
| Experimental: tDCS and EAC<br>Subjects will receive 05 sessions of transcranial direct current stimulation(tDCS) and electroacupuncture(EAC). The tDCS consist of application of current of 2 mA, the anode being placed in the motor cortex (M1) and the cathode in the supraorbital region, for 30 minutes,using electrodes with saline. The electroacupuncture consist of electrical stimulation with a frequency of 2 Hz for 30 min. The needles are placed beside the spinous processes of L1 to S2, with a depth of 3 cm and in the muscles: vastus lateralis, rectus anterioris, vastus medialis, tibialis anterior, peroneus longus and insertion of the pes anserinus. | Other: tDCS and EAC<br>* For the acupuncture we will use needles with guide tubes that are 40 mm in length and 0.25 mm in diameter. The needling will be applied using an electro acupuncture device in the dermatomes, myotome, or sclerotome corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). All patients received one 30min session using a frequency of 2 Hz.<br>* Other names: DIMST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the intensity of daily pain. | 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. | 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. | 
| Change in the pressure pain threshold. | 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. | The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State of physical and mental health. | 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. | The state of physical and mental health will be assessed before and after treatment. Totaly five days. | 
| Level of depressive symptoms . | Depressive symptoms are measured by the Beck Depression Scale, which covers neurovegetative symptoms of depression . | Depressive symptoms will be assessed before and after treatment. Totaly five days. | 
| Daily sleep quality. | Sleep quality will be assessed with the Pittsburgh Sleep Quality Index and the 10cm scale of sleep quality. | Sleep quality will be evaluated daily, totaling five days of evaluation. | 
| Change in the level of functionality. | WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability. | The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electro Acupuncture, Knee Osteoarthritis, Chronic pain, Cortical Excitability