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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hospital de Clinicas de Porto Alegre
Sponsor:
Collaborator:
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01747070
First received: October 15, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Chronic Pain
Other: tDCS and EAC sham
Other: tDCS sham and EAC sham
Other: tDCS sham and EAC
Other: tDCS and EAC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Direct Current Stimulation and Electro Acupuncture in Pain, Functional Capability and Cortical Excitability in Patients With Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • Level of depressive symptoms . [ Time Frame: Depressive symptoms will be assessed before and after treatment. Totaly five days. ] [ Designated as safety issue: No ]
    Depressive symptoms are measured by the Beck Depression Scale, which covers neurovegetative symptoms of depression .

  • Daily sleep quality. [ Time Frame: Sleep quality will be evaluated daily, totaling five days of evaluation. ] [ Designated as safety issue: No ]
    Sleep quality will be assessed with the Pittsburgh Sleep Quality Index and the 10cm scale of sleep quality.

  • 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. ] [ Designated as safety issue: No ]
    WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability.


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tDCS and EAC sham
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
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 Name: Transcranial direct current stimulation.
Placebo Comparator: tDCS sham and EAC sham
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
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 Name: DIMST: deep intramuscular stimulation.
Active Comparator: tDCS sham and EAC
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
For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.
Other Name: DIMST
Experimental: tDCS and EAC
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
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 Name: DIMST

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747070

Contacts
Contact: Wolnei Caumo, PhD +555133598083 caumo@cpovo.net
Contact: Maria da Graça L Tarragó, MD +555199178023 mltarrag@gmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Contact: Wolnei Caumo, PhD    +555133598083    caumo@cpovo.net   
Contact: Maria da Graça L Tarragó, MD    +555199178023    mltarrago@gmail.com   
Sub-Investigator: Maia da Graça L Tarragó, MD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Associação Fundo de Incentivo à Pesquisa
Investigators
Study Director: Wolnei Caumo, PhD Federal University of Rio Grande do Sul
  More Information

Publications:

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01747070     History of Changes
Other Study ID Numbers: 110013, U1111-1130-1855
Study First Received: October 15, 2012
Last Updated: December 10, 2012
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Hospital de Clinicas de Porto Alegre:
Electro Acupuncture
Knee Osteoarthritis
Chronic pain
Cortical Excitability

Additional relevant MeSH terms:
Osteoarthritis
Chronic Pain
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014