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Behavioural Intervention

Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

N/A
Waitlist Available
Led By Cynthia Aranow, M.D.
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 days

Summary

This trial is testing a new treatment for people with Systemic Lupus Erythematosus (SLE) who have musculoskeletal pain. The treatment involves using a device to send mild electrical signals to the vagus nerve through the skin. This process aims to reduce pain and inflammation by activating the body's natural anti-inflammatory pathway. Recent studies suggest that this method has few side effects and beneficial effects on fatigue, pain, disease activity, and organ function.

Eligible Conditions
  • Musculoskeletal Pain
  • Lupus
  • Systemic Lupus Erythematosus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Musculoskeletal pain.
Secondary study objectives
Fatigue
Musculoskeletal Pain
Therapeutic procedure
+3 more
Other study objectives
CpG stimulated levels of TNF, IL-6, Il1B, IFNα and IL10 in whole blood.
Interleukin-1
HMGB1 Protein
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vagus Nerve StimulationActive Control1 Intervention
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
Group II: Sham Vagus Nerve StimulationPlacebo Group1 Intervention
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
475 Previous Clinical Trials
469,266 Total Patients Enrolled
John and Marcia Goldman FoundationUNKNOWN
Cynthia Aranow, M.D.Principal InvestigatorNorthwell Health
1 Previous Clinical Trials
43 Total Patients Enrolled
~2 spots leftby Dec 2025
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