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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo, 이집트
- Faculty of Physical Therapy, Cairo University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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International Restless Leg Syndrome Rating Scale (IRLS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pittsburgh Sleep Quality Index (PSQI
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Marwa Mahmoud El Sayed, Assistant Professor, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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transcutaneous electrical nerve stimulation (TENS)에 대한 임상 시험
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University of Malaga아직 모집하지 않음스트레스 | 불명증 | 수면 장애