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

Primary Purpose

Osteoarthritis, Knee, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
tDCS and EAC sham
tDCS sham and EAC sham
tDCS sham and EAC
tDCS and EAC
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Electro Acupuncture, Knee Osteoarthritis, Chronic pain, Cortical Excitability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Experimental

Arm Label

tDCS and EAC sham

tDCS sham and EAC sham

tDCS sham and EAC

tDCS and EAC

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in the intensity of daily pain.
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.
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.
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 .
Depressive symptoms are measured by the Beck Depression Scale, which covers neurovegetative symptoms of depression .
Daily sleep quality.
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index and the 10cm scale of sleep quality.
Change in the level of functionality.
WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability.

Full Information

First Posted
October 15, 2012
Last Updated
August 17, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01747070
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Chronic Pain
Keywords
Electro Acupuncture, Knee Osteoarthritis, Chronic pain, Cortical Excitability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS and EAC sham
Arm Type
Active Comparator
Arm Description
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.
Arm Title
tDCS sham and EAC sham
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
tDCS sham and EAC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
tDCS and EAC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
tDCS and EAC sham
Other Intervention Name(s)
Transcranial direct current stimulation.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
tDCS sham and EAC sham
Other Intervention Name(s)
DIMST: deep intramuscular stimulation.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
tDCS sham and EAC
Other Intervention Name(s)
DIMST
Intervention Description
For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.
Intervention Type
Other
Intervention Name(s)
tDCS and EAC
Other Intervention Name(s)
DIMST
Intervention Description
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 Outcome Measure Information:
Title
Change in the intensity of daily pain.
Description
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.
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.
Title
Change in the pressure pain threshold.
Description
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.
Time Frame
The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
Secondary Outcome Measure Information:
Title
State of physical and mental health.
Description
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.
Time Frame
The state of physical and mental health will be assessed before and after treatment. Totaly five days.
Title
Level of depressive symptoms .
Description
Depressive symptoms are measured by the Beck Depression Scale, which covers neurovegetative symptoms of depression .
Time Frame
Depressive symptoms will be assessed before and after treatment. Totaly five days.
Title
Daily sleep quality.
Description
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index and the 10cm scale of sleep quality.
Time Frame
Sleep quality will be evaluated daily, totaling five days of evaluation.
Title
Change in the level of functionality.
Description
WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability.
Time Frame
The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
Other Pre-specified Outcome Measures:
Title
Cortical excitability:Motor threshold (MT), Motor evoked potential (MEP),silent period (SP), intracortical facilitation (ICF)and intracortical inhibition (ICI).
Description
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.
Time Frame
The cortical excitability is evaluated before and after treatment with a transcranial magnetic stimulation (TMS) equipment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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18541887
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Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis

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