Clinical Trials Directory

Trials / Completed

CompletedNCT01747070

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Hospital de Clinicas de Porto Alegre · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERtDCS and EAC shamThe 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.
OTHERtDCS sham and EAC shamFor 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.
OTHERtDCS sham and EACFor the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.
OTHERtDCS and EACFor 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.

Timeline

Start date
2014-03-01
Primary completion
2016-03-01
Completion
2016-12-01
First posted
2012-12-11
Last updated
2017-08-22

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01747070. Inclusion in this directory is not an endorsement.