Transcutaneous Electrical Nerve Stimulation in Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Tolerability of the TENS device
研究概览
简要总结
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is:
To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.
Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
- •Age >= 18 years
- •English speaking.
- •Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
- •Stable GI specific therapy including prokinetics over the last 4 weeks.
排除标准
- •Pregnancy, or currently lactating.
- •A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
- •Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
- •Known allergy to adhesive ECG electrodes.
- •Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
研究组 & 干预措施
Scleroderma Patients with Gastroparesis Symptoms
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
结局指标
主要结局
Tolerability of the TENS device
时间窗: 14 months
1. Proportion of subjects who are able to complete the trial 2. Proportion of subjects who utilize the device for at least 80% of the proposed applications.
Acceptability of the TENS Device
时间窗: 4 weeks
Acceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications.
次要结局
- Efficacy of TENS in treating Scleroderma-related Gastroparesis(14 months)
- Assessment of the Effect of TENS of Gastroparesis Symptoms(14 months)
- Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis(14 months)
- Efficacy of TENS in Treating Scleroderma-related Gastroparesis(4 weeks)
- Assessment of the Effect of TENS of Gastroparesis Symptoms(4 weeks)
- Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis(8 weeks)
- Gastric Motility in Participants(4 weeks)
研究者
Dinesh Khanna, MD, MS
Professor of Rheumatology, University of Michigan Scleroderma Program Director
University of Michigan