Clinical Trial: Using the Cholinergic Anit-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Using the Cholinergic Anit-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

Brief 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. 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.

Detailed Summary:
Sponsor: Northwell Health

Current Primary Outcome: Musculoskeletal pain. [ 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SLE Disease activity [ Time Frame: 5 days ]
    SLE disease activity will be assessed using the SLEDAI, a validated disease activity instrument for SLE.
  • Fatigue [ Time Frame: 5 days ]
    Fatigue will be measured using the FACET F questionnaire which will be completed by each subject.
  • Fatigue [ Time Frame: 12 days ]
    Fatigue will be measured using the FACET F questionnaire which will be completed by each subject.
  • Tender and swollen joint counts [ Time Frame: 5 days ]
    The number of tender and swollen joints of the subject will be assessed by the investigator who will examine 68 potential tender joints and 66 potential swollen joints.
  • Tender and swollen joint counts [ Time Frame: 12 days ]
    The number of tender and swollen joints of the subject will be assessed by the investigator who will examine 68 potential tender joints and 66 potential swollen joints.
  • SLE cutaneous activity [ Time Frame: 5 days ]
    Cutaneous activity will be assessed using the CLASI, a validated index for SLE skin disease.
  • SLE cutaneous activity [ Time Frame: 12 days ]
    Cutaneous activity will be assessed using the CLASI, a validated index for SLE skin disease.
  • Musculoskeletal Pain [ Time Frame: 12 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 treatment emergent adverse events will be assessed using the NCI-CTAEversion4.


Original Secondary Outcome:

  • SLE Disease activity [ Time Frame: 5 days ]
    SLE disease activity will be assessed using the SLEDAI, a validated disease activity instrument for SLE.
  • Fatigue [ Time Frame: 5 days ]
    Fatigue will be measured using the FACET F questionnaire which will be completed by each subject.
  • Fatigue [ Time Frame: 12 days ]
    Fatigue will be measured using the FACET F questionnaire which will be completed by each subject.
  • Tender and swollen joint counts [ Time Frame: 5 days ]
    The number of tender and swollen joints of the subject will be assessed by the investigator who will examine 68 potential tender joints and 66 potential swollen joints.
  • Tender and swollen joint counts [ Time Frame: 12 days ]
    The number of tender and swollen joints of the subject will be assessed by the investigator who will examine 68 potential tender joints and 66 potential swollen joints.
  • SLE cutaneous activity [ Time Frame: 5 days ]
    Cutaneous activity will be assessed using the CLASI, a validated index for SLE skin disease.
  • SLE cutaneous activity [ Time Frame: 12 days ]
    Cutaneous activity will be assessed using the CLASI, a validated index for SLE skin disease.
  • Musculoskeletal Pain [ Time Frame: 12 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.


Information By: Northwell Health

Dates:
Date Received: May 26, 2016
Date Started: March 2017
Date Completion: June 2017
Last Updated: February 15, 2017
Last Verified: February 2017