Overview

This trial is active, not recruiting.

Conditions osteoarthritis, knee, chronic pain
Treatments tdcs and eac sham, tdcs sham and eac sham, tdcs sham and eac, tdcs and eac
Sponsor Hospital de Clinicas de Porto Alegre
Collaborator Associação Fundo de Incentivo à Pesquisa
Start date January 2012
End date March 2016
Trial size 60 participants
Trial identifier NCT01747070, 110013, U1111-1130-1855

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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.
tdcs and eac sham Transcranial direct current stimulation.
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.
(Placebo Comparator)
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.
tdcs sham and eac sham DIMST: deep intramuscular stimulation.
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.
(Active Comparator)
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.
tdcs sham and eac DIMST
For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.
(Experimental)
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.
tdcs and eac DIMST
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.

Primary Outcomes

Measure
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.
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.

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Effect of Transcranial Direct Current Stimulation and Electro Acupuncture in Pain, Functional Capability and Cortical Excitability in Patients With Osteoarthritis.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre.