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NCT Number: NCT01747070

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS and EAC sham

Other

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.

Other names: Transcranial direct current stimulation.

tDCS sham and EAC sham

Other

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.

Other names: DIMST: deep intramuscular stimulation.

tDCS sham and EAC

Other

For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.

Other names: DIMST

tDCS and EAC

Other

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.

Other names: DIMST

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. Level of depressive symptoms .

    Time frame: 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 .

  3. Daily sleep quality.

    Time frame: 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.

  4. 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.

    WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability.

Other outcomes

  1. Cortical excitability:Motor threshold (MT), Motor evoked potential (MEP),silent period (SP), intracortical facilitation (ICF)and intracortical inhibition (ICI).

    Time frame: The cortical excitability is evaluated before and after treatment with a transcranial magnetic stimulation (TMS) equipment.

    MagPro X100 and a figure-of-8 coil centered over the motor cortex (M1).MEP - will be made 10 stimuli with an intensity of 120% of motor threshold (MT). SP- is determined from the maximum force of adduction of right thumb measured with a dynamometer. The patient has 20% of maximum strength of adduction of the thumb and it is the stimulus 120% MT of the contralateral hemisphere. The SP is the time needed to recover 50% of the initial voltage obtained in electromyographic register. ICF - is investigated by paired pulse. TMS will be used with expansion module for paired pulse. Conditioning stimulus intensity is 80% of the MT and the intensity of the stimulus test is 120% of the MT. The inter-stimulus will be 12 microsec. ICI - Investigated by paired pulse. TMS will be used with expansion module for paired pulse. Conditioning stimulus intensity is 80% of the MT and the intensity of the stimulus test is 120% of the MT. The inter-stimulus interval is 2 microsec.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Associação Fundo de Incentivo à Pesquisa

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2012
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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