Stellate Ganglion Stimulation for Restless Leg Syndrome in Hemodialysis Patients
Effect of Transcutaneous Stellate Ganglion Electrical Stimulation on Restless Leg Syndrome in Hemodialysis Patients
This randomized controlled trial investigated the effect of transcutaneous stellate ganglion electrical nerve stimulation (TENS-SG) on restless legs syndrome (RLS) in patients undergoing hemodialysis. Thirty-six patients aged 40-50 years were randomly assigned to two equal groups: Group A received active TENS-SG applied over the cervical-thoracic (stellate ganglion) region three times weekly for four weeks, while Group B received placebo stimulation.
The study evaluated multiple outcomes including RLS severity (IRLS scale), sleep quality (PSQI), quality of life (SF-12), pain perception (pressure pain threshold), blood pressure, psychological status (HADS), and plasma β-endorphin levels.
Results demonstrated that TENS-SG significantly reduced RLS severity and improved sleep quality, pain threshold, quality of life, and psychological well-being compared to placebo. It also significantly reduced systolic and diastolic blood pressure and markedly increased β-endorphin levels.
Overall, the findings suggest that TENS-SG is a safe, non-invasive, and effective intervention for improving neurological, cardiovascular, psychological, and quality-of-life outcomes in hemodialysis patients with RLS.
調査の概要
状態
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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Cairo、エジプト
- Faculty of Physical Therapy, Cairo University
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
36 patients will be involved in this study according to the following criteria
Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including
- an urge to move legs that is usually associated with paresthesia.
- alleviation of the symptoms by moving the legs.
- aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
- worsening of the signs at night.
- Male and Female patients.
- The age will range from 40-50 years old.
- BMI (Body Mass Index 25-34.9 kg/m2
- Patients with grade 2 Hypertension (160-179/100-109 mmHg)
- Hemodialysis patients for at least 1year and have restless leg syndrome (RLS).
Exclusion Criteria:
History of Deep venous thrombosis
- History of Bleeding disorders
- Have an implantable device like a pacemaker
- Recent Infected wound
- History of allergic response to the electrodes, gel or tape
- patients who participating in any other exercise program
- Loss of sensation or numbness
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：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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実験的：TENS Group
Patients will receive transcutaneous stellate ganglion stimulation three times per week for four weeks in addition to standard care
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Transcutaneous electrical nerve stimulation is applied over the stellate ganglion region three times per week for four weeks.
The stimulation is used as a non-invasive neuromodulation technique to manage restless legs syndrome in hemodialysis patients.
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プラセボコンパレーター：Sham Stimulation Control Group
Patients will receive a placebo (sham) TENS intervention with electrodes applied but no electrical stimulation (zero intensity), in addition to standard care
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Electrodes are applied over the same anatomical site as the active intervention; however, no electrical current is delivered (zero intensity).
The procedure mimics the active treatment to ensure blinding of participants.
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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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International Restless Leg Syndrome Rating Scale (IRLS)
時間枠：Baseline and 4 weeks after treatment
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Assessment of restless legs syndrome severity using the International Restless Legs Syndrome Rating Scale
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Baseline and 4 weeks after treatment
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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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Pittsburgh Sleep Quality Index (PSQI
時間枠：Baseline and 4 weeks after treatment
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Assessment of sleep quality using the Pittsburgh Sleep Quality Index
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Baseline and 4 weeks after treatment
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Short Form-12 Health Survey (SF-12)
時間枠：Baseline and 4 weeks after treatment
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Assessment of health-related quality of life using the SF-12 questionnaire
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Baseline and 4 weeks after treatment
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Pressure Pain Threshold
時間枠：Baseline and 4 weeks after treatment
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Assessment of pressure pain threshold using pressure algometry
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Baseline and 4 weeks after treatment
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Plasma Beta-Endorphin Level
時間枠：Baseline and 4 weeks after treatment
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Measurement of plasma beta-endorphin concentration from blood samples
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Baseline and 4 weeks after treatment
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Marwa Mahmoud El Sayed, Assistant Professor、Cairo University
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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