Lupus Erythematosus, SystemicNCT02822989
Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
A study testing Vagus nerve stimulation in people with Lupus Erythematosus, Systemic and Musculoskeletal Pain, run by Northwell Health at 1 site in United States.
Trial summary
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, Musculoskeletal Pain
- What is being tested?
- Vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years,
- SLE (defined by the ACR or SLICC criteria),
- Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
- BILAG C on Musculoskeletal Domain of the BILAG 2004
- If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
- If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Who cannot join
- Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion),
- Treatment with cyclophosphamide within 2 months of baseline,
- Expectation to increase steroids and/or immunosuppressive treatment,
- Anti-phospholipid syndrome,
- Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom Scale (FSS).
- Treatment with an anti-cholinergic medication, including over the counter medications,
Show all 18Show fewer
- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- Current tobacco or nicotine user,
- Joint replacement within 60 days prior to study enrollment or planned within the course of the study,
- Any planned surgical procedure requiring general anesthesia within the course of the study,
- Intra-articular cortisone injections within 28 days of the start of study,
- Chronic inflammatory disorders apart from SLE affecting the joints,
- Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
- Active infection including hepatitis B or hepatitis C at baseline,
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
- Pregnancy or lactation,
- Comorbid disease that may require administration of corticosteroid use,
- Inability to comply with study and follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Cholinergic Anit-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.
- Being tested
- Vagus nerve stimulation, Sham vagus nerve stimulation
- Keywords
- Lupus Erythematosus, Systemic, Musculoskeletal Pain, Inflammation
- Medical subject headings
- Lupus Erythematosus, Systemic, Musculoskeletal Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulationDevice
Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
Sham vagus nerve stimulationDevice
Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Stimulation | Active comparator | Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days. Receives: Device: Vagus nerve stimulation |
| Sham Vagus Nerve Stimulation | Sham comparator | Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. Receives: Device: Sham vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Musculoskeletal Pain From Baseline.
Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Measured: 5 days
Percentage of Subjects With Treatment Emergent Adverse Events.
The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4.
Measured: 12 days
Secondary outcomes (11)
Change in Musculoskeletal Pain From Baseline
Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Measured: 12 days
Fatigue
Change from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.
Measured: 5 days
Fatigue
Change from baseline fatigue will be measured using the FACIT F (Functional Assessment of Chronic Illness Therapy) questionnaire. The score ranges from 0 to 52, a higher score indicates less fatigue.
Measured: 12 days
Tender Joint Reduction
The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.
Measured: 5 days
Tender Joint Reduction
The percentage of tender joints reduced from baseline assessed by an investigator upon examining 68 potential tender joints.
Measured: 12 days
Swollen Joint Count Reduction
The percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.
Measured: 5 days
Swollen Joint Count Reduction
The percentage of swollen joints reduced from baseline assessed by an investigator upon examining 66 potential swollen joints. Data shown for seven taVNS and five SS subjects with swollen joints at baseline.
Measured: 12 days
Physician Global Assessment of Disease Activity (PGA)
Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.
Measured: 5 days
Physician Global Assessment of Disease Activity (PGA)
Change in PGA from baseline, an anchored visual analog scale.ranging from 0 to 3 with higher scores signifying higher disease activity.
Measured: 12 days
Patient Global Assessment of Disease (PtGA)
Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity.
Measured: 5 days
Patient Global Assessment of Disease (PtGA)
Change in Patient Global Assessment of disease (PtGA) from baseline. This measure is a 10 cm visual analog scale (0-10); higher scores indicate a higher patient assessment of their disease activity.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start1 Nov 2017
- Primary completion30 Apr 2018
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- John and Marcia Goldman Foundation
- Responsible party
- Principal investigator, Cynthia Aranow, MD, Northwell Health
- Investigators
- Cynthia Aranow, M.D., Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822989
- Sponsor's protocol ID
- HS16-0171
- Status last verified
- Jun 2026
- First submitted
- 26 May 2016
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Cholinergic Anit-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT02822989
- Acronym / sponsor ID
- HS16-0171
- Keywords
- Lupus Erythematosus, Systemic, Musculoskeletal Pain, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- John and Marcia Goldman Foundation
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Stimulation | Active comparator | Device: Vagus nerve stimulationSubjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days. |
| Sham Vagus Nerve Stimulation | Sham comparator | Device: Sham vagus nerve stimulationSubjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years,
- SLE (defined by the ACR or SLICC criteria),
- Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
- BILAG C on Musculoskeletal Domain of the BILAG 2004
- If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
Key exclusion criteria (18 listed)
- Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion),
- Treatment with cyclophosphamide within 2 months of baseline,
- Expectation to increase steroids and/or immunosuppressive treatment,
- Anti-phospholipid syndrome,
- Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom Scale (FSS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus nerve stimulationPatients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch. | Device | Vagus Nerve Stimulation |
| Sham vagus nerve stimulationPatients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve. | Device | Sham Vagus Nerve Stimulation |
Primary outcome
Change in Musculoskeletal Pain From Baseline.
Time frame: 5 days
Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Percentage of Subjects With Treatment Emergent Adverse Events.
Time frame: 12 days
The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4.
11 secondary outcomes
Change in Musculoskeletal Pain From Baseline
Time frame: 12 days
Fatigue
Time frame: 5 days
Fatigue
Time frame: 12 days
Tender Joint Reduction
Time frame: 5 days
Tender Joint Reduction
Time frame: 12 days
Swollen Joint Count Reduction
Time frame: 5 days
Swollen Joint Count Reduction
Time frame: 12 days
Physician Global Assessment of Disease Activity (PGA)
Time frame: 5 days
Physician Global Assessment of Disease Activity (PGA)
Time frame: 12 days
Patient Global Assessment of Disease (PtGA)
Time frame: 5 days
Patient Global Assessment of Disease (PtGA)
Time frame: 12 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Aranow, M.D. principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation in people with Lupus Erythematosus, Systemic and Musculoskeletal Pain, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Musculoskeletal Pain From Baseline. (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.