The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in periodic limb movement
研究概览
简要总结
The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Clinical diagnosis of restless legs syndrome
排除标准
- •Active cancer diagnoses
- •Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),
- •Pregnancy
- •Immunocompromised disease (e.g., HIV, AIDS, lupus)
- •Insufficient English-language skills to complete all questionnaires
- •Inability to maintain treatment positions
- •Contraindications to dry needling:35,36
- •Presence of needle phobia
- •History of abnormal reaction to needling or injection
- •History of bleeding disorder
研究组 & 干预措施
Dry needling with electrical stimulation
Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities
干预措施: Dry Needling with electrical stimulation (Procedure)
结局指标
主要结局
Change in periodic limb movement
时间窗: Baseline, weekly for 3 weeks
Measured using a consumer-grade sleep tracking device.
Change in Restless Legs Syndrome symptom severity
时间窗: Baseline, 4 weeks and 8 weeks post-intervention
RLS symptom severity of each participant will be indexed with likert scale ratings and subacutely by completion of the International Restless Legs Syndrome Rating Scale (IRLSRS). The IRLSRS has demonstrated to be a valid and reliable outcome measure for RLS symptom severity. The scale consists of 10 questions concerning each patient's symptoms and the impact of those symptoms on daily activities and mood. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40 with higher scores indicating more severe symptoms.
Change in sleep quality
时间窗: Baseline, 4 weeks and 8 weeks post-intervention
Measured using the Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire that measures general sleep quality. The scoring range is 0-21 with 0-3 scoring for each component. Higher scores indicate worse sleep quality.
次要结局
- Change in quality of life(Baseline, 4 weeks and 8 weeks post-intervention)
- Change in pain level(Baseline, 4 weeks and 8 weeks post-intervention)
- Acute change in Restless Legs Syndrome symptoms(Baseline, Immediately post-intervention)
研究者
Ray M. Lunasin
Principal Investigator
Mayo Clinic