NCT07256067Completed
Vagus Nerve Stimulation for Fatigue in Systemic Lupus
The Effect of Vagus Nerve Acupoint Transcutaneous Electrical Nerve Stimulation on Fatigue in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 29 Sept 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 2 Oct 2025
- Lead sponsor
- Cairo University
- Diseases
- Lupus (SLE)
- NCT number
- NCT07256067
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Aug 2025 to the primary completion date, 2 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of pacemakers, implantable cardioverter defibrillators (ICDs), or other electronic implants.
Other illness
- Diagnosis of fibromyalgia or any other overlapping chronic pain syndrome.
- History of epilepsy or seizure disorders.
Other
- Current pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 35 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Physical Therapy Coordinator of this site? Confirm its status | Giza | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.