tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
調査の概要
詳細な説明
Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why its therapeutic approach is refractory to current treatments.
Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.
In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.
The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients with fibromyalgia.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Toledo
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Talavera De La Reina、Toledo、スペイン、45600
- Hospital General Nuestra Señora del Prado
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age between 18 and 65 years.
- Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- Normal pain intensity of 4 or more points on a visual analog scale.
- Able to participated in a therapeutic exercise program.
- Understanding of spoken and written Spanish.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Metallic implants in the head.
- Tumor, trauma or surgery in the brain.
- Epilepsy or stroke.
- History of substance abuse in the last 6 months.
- Use of carbamazepine in the last 6 months.
- Severe depression (Beck Depression Index II of 29 or more).
- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
- Coexisting autoimmune pathology.
- Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
研究計画
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：コントロール
治療なし。
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実験的：Real tDCS + exercise
Transcranial direct current stimulation combined with therapeutic exercise
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Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days.
The program will include exercises and will last 30-45 minutes.
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偽コンパレータ：Sham tDCS + exercise
Sham transcranial direct current stimulation combined with therapeutic exercise
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The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days.
The program will include exercises and will last 30-45 minutes.
Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.
Sham tDCS will be applied for the same time than real tDCS.
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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 referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
時間枠：Baseline; immediately after intervention; 1-month after intervention
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A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds. After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark). |
Baseline; immediately after intervention; 1-month after intervention
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Change in pain intensity from baseline to post-treatment
時間枠：Baseline; immediately after intervention; 1-month after intervention
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It will be measured with a visual analog scale (VAS) of 100 millimeters in length.
The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable
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Baseline; immediately after intervention; 1-month after intervention
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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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線維筋痛症は生活の質に影響を与える
時間枠：ベースライン;介入直後;介入後1ヶ月
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Fibromyalgia Impact Questionnaire (FIQ) のスペイン語に適合したバージョンで測定されます。
スケールの範囲は 0 ～ 100 です。
値が高いほど結果が悪いことを表します。
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ベースライン;介入直後;介入後1ヶ月
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Anxiety
時間枠：Baseline; immediately after intervention; 1-month after intervention
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The version adapted to Spanish from the State Scale (STAI-ES) of the State-Trait Anxiety Inventory (STAI) will be used.
The scale ranges from 0 to 60. Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Pain catastrophizing
時間枠：Baseline; immediately after intervention; 1-month after intervention
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The Spanish version of the Pain Catastrophizing Scale (PCS) will be used.
The scale ranges from 0 to 52.
Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Depression
時間枠：Baseline; immediately after intervention; 1-month after intervention
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The adaptation to the Spanish of Beck Depression Inventory II will be used.
The scale ranges from 0 to 63.
Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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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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Blinding
時間枠：Immediately after intervention
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Blinding of subjects and researchers will be assessed using the James Index.
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Immediately after intervention
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Real tDCSの臨床試験
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The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of Waterloo募集
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National University Hospital, SingaporeNational University Health System, Singapore; Agency for Science, Technology and Research完了
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Weill Medical College of Cornell UniversityAmerican Heart Association募集
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Arizona State UniversityUniversidad Autonoma de Nuevo Leon; Instituto Nacional Psiquiatrico de México - Ciudad de México と他の協力者完了