Clinical trial NCT01747070: Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis
Official title: Effect of Transcranial Direct Current Stimulation and Electro Acupuncture in Pain, Functional Capability and Cortical Excitability in Patients With Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Chronic Pain
Keywords: Electro Acupuncture
Knee Osteoarthritis
Chronic pain
Cortical Excitability
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
First posted: 2012-12-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the intensity of daily pain.
timeFrame: 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.
measure: Change in the pressure pain threshold.
timeFrame: 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.
timeFrame: The state of physical and mental health will be assessed before and after treatment. Totaly five days.
measure: Level of depressive symptoms .
timeFrame: Depressive symptoms will be assessed before and after treatment. Totaly five days.
measure: Daily sleep quality.
timeFrame: Sleep quality will be evaluated daily, totaling five days of evaluation.
measure: Change in the level of functionality.
timeFrame: The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
Other outcomes:
measure: Cortical excitability:Motor threshold (MT), Motor evoked potential (MEP),silent period (SP), intracortical facilitation (ICF)and intracortical inhibition (ICI).
timeFrame: The cortical excitability is evaluated before and after treatment with a transcranial magnetic stimulation (TMS) equipment.
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Wolnei Caumo, PhD
role: STUDY_DIRECTOR
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