Vagus Nerve Stimulation for Fatigue in Systemic Lupus

November 27, 2025 updated by: Asmaa Saed Mahmoud Ebrahim, Cairo University

The Effect of Vagus Nerve Acupoint Transcutaneous Electrical Nerve Stimulation on Fatigue in Patients With Systemic Lupus Erythematosus: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

• Therapeutic Equipment: .Transcutaneous auricular vagus nerve stimulation (taVNS) was administered exclusively with fixed stimulation parameters set at a frequency of 30 Hz and a pulse width of 300 μs.

  • Only spring-loaded clip electrodes were used for stimulation on the left ear.
  • an aerobic exercises designed to improve mobility, strength, and fatigue tolerance lasted 40 minutes and included treadmill, walking andcycling with moderate intensity (60-70% max HR and frequency 3 sessions per week
  • No additional therapies (e.g., resistance training, aquatic therapy, or medications) were included in the intervention.

Measurement equipment:

• Fatigue severity scale: 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. For example, Al-Sobayel et al. (2016) reported a Cronbach's α of 0.93 for the Arabic FSS in a population of Arabic-speaking patients with chronic diseases, including SLE. This makes the Arabic FSS a culturally appropriate and psychometrically sound instrument for assessing fatigue in Arabic-speaking populations.

Six-Minute Walk Test (6MWT) is a sub-maximal exercise test that measures the distance a person can walk as far as possible in six minutes along a flat, hard surface.

It is used to assess functional exercise capacity, endurance, and the integrated global response of many systems: pulmonary and cardiac function, circulation, peripheral circulation, neuromuscular function, The test can show performance fatigability when there is a decline in the individual's walking speed or distance over time (for instance, comparing the first minute of walking vs the last minute.

Borg Rating of Perceived Exertion (RPE) ("Borg Test") is a subjective scale developed by Gunnar Borg, used to gauge how hard someone feels they are working during physical activity. It captures feelings of exertion, breathlessness, muscle fatigue, heart rate

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Egpt
      • Giza, Egpt, Egypt, 12613
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: transcutaneous vagus nerve stimulation (tVNS)

Transcutaneous auricular vagus nerve stimulation (taVNS) was administered exclusively with fixed stimulation parameters set at a frequency of 30 Hz and a pulse width of 300 μs.3times a week for 6 week.

  • Only spring-loaded clip electrodes were used for stimulation on the left ear.
  • an aerobic exercises designed to improve mobility, strength, and fatigue tolerance lasted 40 minutes and included treadmill, walking andcycling with moderate intensity (60-70% max HR and frequency 3 sessions per week
  • No additional therapies (e.g., resistance training, aquatic therapy, or medications) were included in the intervention.
Sham Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue severity scale
Time Frame: 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-Minute Walk Test (6MWT) andBorg Rating of Perceived Exertion (RPE) (Borg Test)
Time Frame: 6 weeks

The 6MWT is a sub-maximal exercise test that measures the distance a person can walk as far as possible in six minutes along a flat, hard surface.

It is used to assess functional exercise capacity, endurance, and the integrated global response of many systems: pulmonary and cardiac function, circulation, peripheral circulation, neuromuscular function, The test can show performance fatigability when there is a decline in the individual's walking speed or distance over time (for instance, comparing the first minute of walking vs the last minute. That was measured by map by walk phone application.
6 weeks
Borg rating scale
Time Frame: 6 weeks
RPE is a subjective scale developed by Gunnar Borg, used to gauge how hard someone feels they are working during physical activity. It captures feelings of exertion, breathlessness, muscle fatigue, heart rate
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Research Ethical Committee, Faculty of Physical Therapy, Faculty of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

October 2, 2025

Study Completion (Actual)

November 2, 2025

Study Registration Dates

First Submitted

September 29, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2062021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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