The Effect of Vagus Nerve Acupoint Transcutaneous Electrical Nerve Stimulation on Fatigue in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fatigue severity scale
研究概览
简要总结
50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally distributed into two groups.
Group A :(Treatment Group):
This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR),and will receive transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks, the time of session is 45 - 60 min according to patient ability.
Group B :( Control Group) This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR)and will receive sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks.
详细描述
1)Subjects: 50female patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR). Their age will range from 35 to 55 years. The participants will be selected from one major healthcare institutions: Al Kaser Al Ayni Teaching hospital, will be randomly equally distributed into two groups.
Group A :(Treatment Group):
This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR),and will receive transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks, the time of session is 45 - 60 min according to patient ability.
Group B :( Control Group) This group includes 25 patients diagnosed with systemic lupus erythematosus according to the 2010 Revised American College of Rheumatology (ACR)and will receive sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program alongside medical treatment. Patients will receive 3 sessions per week for 6 weeks.
2)Equipment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults aged 35 to 55 years
- •Diagnosis of Systemic Lupus Erythematosus (SLE) based on the 2010 Revised American College of Rheumatology (ACR) or SLICC classification criteria.
- •Self-reported pain score of ≥4 on a 10 cm Visual Analogue Scale (VAS).
- •Receiving stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs), biological therapy, and/or prednisone ≤10 mg/day, with no changes in dose within 28 days prior to baseline.
- •They have been referred by a rheumatologist.
排除标准
- •Diagnosis of fibromyalgia or any other overlapping chronic pain syndrome.
- •Use of pacemakers, implantable cardioverter defibrillators (ICDs), or other electronic implants.
- •Current pregnancy or breastfeeding.
- •History of epilepsy or seizure disorders.
研究组 & 干预措施
Experimental:Transcutanousvagus nerve stimulation plus aerobic exercise
Transcutaneous vagus nerve stimulation (tVNS), combined with aerobic exercise. Stimulation will be applied to the left auricular concha for 20 minutes per session, three times per week for six weeks, using standardized settings (30 Hz frequency, 300 μs pulse width) at a tolerable, non-painful intensity. This will be followed by 40 minutes of aerobic exercises.
干预措施: transcutaneous vagus nerve stimulation (tVNS) (Device)
sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise
sham transcutaneous vagus nerve stimulation (tVNS) using the same device and electrode placement. They will also perform the same 40-minute aerobic exercise program.
干预措施: sham transcutaneous vagus nerve stimulation (tVNS) plus aerobic exercise (Other)
结局指标
主要结局
Fatigue severity scale
时间窗: 6 weeks
The Fatigue Severity Scale (FSS) is a widely used self-report questionnaire designed to assess the impact of fatigue on daily functioning. It consists of nine statements rated on a 7-point Likert scale, with higher scores indicating greater fatigue severity. The FSS has demonstrated strong psychometric properties in patients with systemic lupus erythematosus (SLE), including excellent internal consistency (Cronbach's α \> 0.90) and good test-retest reliability (ICC = 0.84-0.89). The Arabic version of the FSS has been validated in multiple studies and has shown comparable reliability and construct validity to the original version.
次要结局
- Six-Minute Walk Test (6MWT) andBorg Rating of Perceived Exertion (RPE) (Borg Test)(6 weeks)
- Borg rating scale(6 weeks)
研究者
Asmaa Saed Mahmoud Ebrahim
Teaching assistant in the Department of Surgery and Burns, Faculty of Physical Therapy, Cairo University
Cairo University