Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis
2017年8月17日 更新者：Hospital de Clinicas de Porto Alegre
Effect of Transcranial Direct Current Stimulation and Electro Acupuncture in Pain, Functional Capability and Cortical Excitability in Patients With 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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90035903
- Hospital de Clinicas de Porto Alegre
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
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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.
他の名前：
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プラセボコンパレーター：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.
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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.
他の名前：
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アクティブコンパレータ：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.
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For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.
他の名前：
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実験的：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in the intensity of daily pain.
時間枠：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.
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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.
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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.
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Change in the pressure pain threshold.
時間枠：The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
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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.
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The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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State of physical and mental health.
時間枠：The state of physical and mental health will be assessed before and after treatment. Totaly five days.
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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.
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The state of physical and mental health will be assessed before and after treatment. Totaly five days.
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Level of depressive symptoms .
時間枠：Depressive symptoms will be assessed before and after treatment. Totaly five days.
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Depressive symptoms are measured by the Beck Depression Scale, which covers neurovegetative symptoms of depression .
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Depressive symptoms will be assessed before and after treatment. Totaly five days.
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Daily sleep quality.
時間枠：Sleep quality will be evaluated daily, totaling five days of evaluation.
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Sleep quality will be assessed with the Pittsburgh Sleep Quality Index and the 10cm scale of sleep quality.
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Sleep quality will be evaluated daily, totaling five days of evaluation.
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Change in the level of functionality.
時間枠：The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
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WOMAC(Western Ontario and McMaster Universities Questionnaire) - assessment of pain, stiffness and functional ability.
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The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Cortical excitability:Motor threshold (MT), Motor evoked potential (MEP),silent period (SP), intracortical facilitation (ICF)and intracortical inhibition (ICI).
時間枠：The cortical excitability is evaluated before and after treatment with a transcranial magnetic stimulation (TMS) equipment.
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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.
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The cortical excitability is evaluated before and after treatment with a transcranial magnetic stimulation (TMS) equipment.
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協力者と研究者
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8. doi: 10.2340/16501977-0535.
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- Laste G, Caumo W, Adachi LN, Rozisky JR, de Macedo IC, Filho PR, Partata WA, Fregni F, Torres IL. After-effects of consecutive sessions of transcranial direct current stimulation (tDCS) in a rat model of chronic inflammation. Exp Brain Res. 2012 Aug;221(1):75-83. doi: 10.1007/s00221-012-3149-x. Epub 2012 Jul 3.
- Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non-convergent neurones, supraspinal involvement and theoretical implications. Pain. 1979 Jun;6(3):305-327. doi: 10.1016/0304-3959(79)90050-2.
- Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.
- Boggio PS, Amancio EJ, Correa CF, Cecilio S, Valasek C, Bajwa Z, Freedman SD, Pascual-Leone A, Edwards DJ, Fregni F. Transcranial DC stimulation coupled with TENS for the treatment of chronic pain: a preliminary study. Clin J Pain. 2009 Oct;25(8):691-5. doi: 10.1097/AJP.0b013e3181af1414.
- da Graca-Tarrago M, Lech M, Angoleri LDM, Santos DS, Deitos A, Brietzke AP, Torres IL, Fregni F, Caumo W. Intramuscular electrical stimulus potentiates motor cortex modulation effects on pain and descending inhibitory systems in knee osteoarthritis: a randomized, factorial, sham-controlled study. J Pain Res. 2019 Jan 3;12:209-221. doi: 10.2147/JPR.S181019. eCollection 2019.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年3月1日
一次修了 (実際)
2016年3月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2012年10月15日
QC基準を満たした最初の提出物
2012年12月10日
最初の投稿 (見積もり)
2012年12月11日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月22日
QC基準を満たした最後の更新が送信されました
2017年8月17日
最終確認日
2017年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。