Treatment for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Saint Louis University, Saint Louis, MO
Chronic Pain+4 More
Eligibility
< 65
All Sexes
What conditions do you have?
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Study Summary

Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effective for CF patients. Abdominal pain negatively impacts the quality of life (QOL). With the development of novel therapies for CF, life expectancy has significantly increased. There is, therefore, a critical need to identify treatment pathways for chronic abdominal pain in children with CF. In humans, abdominal pain is modulated by the vagus nerve. Stimulation of the vagus nerve has been suggested to reduce visceral sensitivity and abdominal pain. IB-stim is the Percutaneous Electrical Nerve Field Stimulation (PENS) device. It is a non-invasive, outpatient therapy. PENFS has been shown to be efficacious in pediatric patients with abdominal pain. The FDA has cleared and classified this device as class II, suggesting minimal to moderate risk. There is increasing evidence of intestinal inflammation in patients with CF, which could help explain the GI symptoms and differentiate from IBS. Studies have reported increased inflammation in the intestines using fecal calprotectin. With the implementation of this study, we hypothesize that the IB -Stim device will reduce their overall GI inflammation and abdominal pain.

Eligible Conditions

  • Chronic Pain
  • Irritable Bowel Syndrome
  • Cystic Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Chronic Pain

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 1-4 weeks and 4-8 weeks

1-4 weeks
To characterize the reduction in stool calprotectin inflammatory markers in response to IB-Stim
Week 8
: To assess the CFQ-R and PedsQL Gastrointestinal Scale Score in response to IB-Stim treatment.
1-8 weeks
To determine whether PENFS therapy improves abdominal pain and IBS-symptom severity in CF.

Trial Safety

Safety Progress

1 of 3

Other trials for Chronic Pain

Trial Design

0 Treatment Group

20 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1-4 weeks and 4-8 weeks
Closest Location: Saint Louis University · Saint Louis, MO
Photo of Saint Louis 1Photo of Saint Louis 2Photo of Saint Louis 3
2004First Recorded Clinical Trial
2 TrialsResearching Chronic Pain
168 CompletedClinical Trials

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,772 Previous Clinical Trials
2,270,661 Total Patients Enrolled
6 Trials studying Chronic Pain
508 Patients Enrolled for Chronic Pain
St. Louis UniversityLead Sponsor
183 Previous Clinical Trials
37,464 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.