"Effect of Combined Traditional and Paraspinal Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of combined traditional and paraspinal acupressure on restless legs syndrome and pruritus among patients undergoing hemodialysis. Participants will be randomly assigned to either an intervention group receiving the acupressure intervention in addition to routine hemodialysis care or a control group receiving routine care only. The severity of restless legs syndrome and pruritus will be assessed at predetermined time points using validated assessment tools. The study aims to determine whether the combined acupressure intervention is effective in reducing restless legs syndrome and pruritus symptoms in patients undergoing hemodialysis
详细描述
Participants allocated to the intervention group will receive combined traditional and paraspinal acupressure in addition to routine hemodialysis care. The intervention will involve stimulation of selected acupressure points using a vibration acupressure device.
The paraspinal component will include selected thoracic and lumbar points (BL13, BL17, BL23, BL24, and BL25) and will be applied before the hemodialysis session. Traditional peripheral acupressure points, including SP6, SP10, ST36, LI11, LR3, and BL57, will be stimulated during the hemodialysis session.The intervention will be administered according to a standardized protocol regarding point localization, application technique, duration, and frequency to ensure consistency among participants. Participants will be observed during the intervention for any discomfort or adverse events.
Participants allocated to the control group will continue to receive routine hemodialysis care without the acupressure intervention during the study period.
Restless legs syndrome severity and pruritus severity will be evaluated using validated instruments at three predetermined assessment time points. The collected data will be used to examine changes in symptoms over time and differences between the two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week.
- •The patients on hemodialysis for more than 3 months
- •The patients who complain of restless leg syndrome and pruritus.
- •RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG).
- •At least moderate RLS symptoms (IRLS - total score ≥ 11)
- •Patients who score more than five on the 5D Pruritus scale.
- •Patient with a history of pruritus for more than 3 months.
排除标准
- •Patients with impaired skin integrity.
- •Patients with skin lesions in areas involved in acupressure therapy.
- •Patients with neurological deficits as perception of pain, may differ from other patients.
- •Patients with a body mass index (BMI) of more than > 30 kg/m².
- •Patients with malignancy.
- •Patients with Jaundice.
研究组 & 干预措施
intervention group (Vibration assisted acupressure)
Participants in this group will receive vibration-assisted acupressure using an acupressure device applied to selected acupoints in addition to routine hemodialysis care. The intervention will be administered according to the study protocol to evaluate its effects on restless legs syndrome and pruritus among patients undergoing
干预措施: Vibration Assisted Acupressure (Other)
CONTROL GROUP
Participants will receive routine hemodialysis care without the acupressure intervention
结局指标
主要结局
Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)
时间窗: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
The questionnaire consisted of 10 items, each of which had a scale ranging from 0 (no impact) to 4 (very severe impact). RLS severity was defined as mild (0-10 points), moderate (11-20 points), severe (21-30 points), or very severe (31-40 points).
Change in Pruritus Severity Assessed by the 5-D Itch Scale
时间窗: Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
Pruritus severity will be assessed using the 5-D Itch Scale, which evaluates five dimensions of itching: duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating greater severity and impact of pruritus
次要结局
未报告次要终点
研究者
Alaa Kadhim Abdul-Hameed
PHD student
University of Baghdad