Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
Phase: NA
Conditions: Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain
Sponsor: St. Louis University

Neuromodulation for Children with Cystic Fibrosis 
Experiencing Chronic Abdominal Pain 
NCT05515250 
Last review date 07/25/2023 
 
 
STUDY PROTOCOL: Eligible participants will be recruited from the gastroenterology or 
Cystic Fibrosis clinics at Cardinal Glennon Hospital, Saint Louis University and Saint 
Louis Children’s Hospital at Washington University in Saint Louis. Consent to participate 
and a detailed history, physical examination and laboratory tests for stool calprotectin will 
be obtained at the participants’ clinical management site. A global assessment of 
abdominal pain will be used to rate its severity. Participants will be allowed to continue 
medication regimens that they are on prior to enrollment. No adjustments in medications 
will be allowed during the 3-week study period unless deemed necessary by the CF care 
team. Also, no new medications or OTC treatments will be allowed during the 3-weeks 
trial of PENFS unless deemed necessary by the CF care team. The use of all medications 
will be carefully monitored each week for future evaluation.    
 
Following screening evaluation, enrolled participants will complete questionnaires and 
have the initial PENFS device placed by a trained health care professional. Device 
placement will then be done at the gastroenterology clinic at Cardinal Glennon Hospital 
to which participants will return every 7 days for a total of 3 visits for device replacement 
and completion of questionnaires. Three different devices will be placed in total (at 
baseline, at the end of week 1, and at the end of week 2). Following each visit and at 
week 8, participants will complete follow-up pain, CFQ-R, IBS-SSS, and PedsQL GI 
symptom scale administered in person by the study clinical coordinator at the clinical 
management site. The PI and sub-investigators at each clinical site will review adverse 
events on a continual basis to watch for unexpected safety signals.  
 

Table 1 presents the expected timeline. The total length of the study, from screening of 
the first participant to the end of the study, is expected to be approximately 12 months 
 
  
Screening/ 
baseline  
End of 
Week 
1  
End of 
Week 2  
End of 
Week 
4  ⃰⃰⃰  ⃰⃰⃰   
8-week 
follow-
up  ⃰⃰⃰  ⃰⃰⃰   
Informed Consent/enrollment  
X  
  
  
  
  
Eligibility assessment 
  
X  
  
  
  
  
Demography and  Medical history 
  
X  
  
  
  
  
Check Current Medication  
 
  
X  
X  
X  
X  
X  
IB-Stim Placement   
X  
X  
X  
  
  
Pain Score ⃰⃰⃰   
X  
X  
X  
X  
X  
CFQ-R ⃰⃰⃰   
X  
X  
X  
X  
X  
IBS-SSS ⃰⃰⃰   
X  
X  
X  
X  
X  
PedsQL GI symptom scale Version 3.0 ⃰⃰⃰   
X  
X  
X  
X  
X  
Stool Calprotectin  
Xa  
  
  
Xb  
  
 
STATISTICAL PLAN(in conjunction with the AHEAD Institute at St. Louis 
University): The primary endpoint for this study is the change in the abdominal pain 
scores from baseline to study exit. The secondary endpoints will be the change in the 
IBS-SSS (Symptoms Severity Scale), CFQ-R, and PedsQL Gastrointestinal symptom 
scale from baseline to study exit. The median pain scores will be computed at the three 
time points in the study (baseline, at 4 weeks and at 8 weeks) and compared using the 
non-parametric Kruskal Wallis test. Ad-hoc pairwise comparisons will be done using the 
Dwass, Steel, Critchlow-Fligner multiple comparison procedure (10,11). Trends in these 
indices over time will be compared using mixed models adjusting for repeated measures. 
These statistics will also be computed for the secondary endpoints. REDCap (Research 
Electronic Data Capture), a secure web-based application or password protected excel, 
will be used for data management and storage. P-values < 0.05 are considered significant. 
All analysis will be two-sided and completed in SAS 9.4 or the current version of SAS at 
the time of the study (SAS Institute Inc., Cary, NC, USA).  
Due to less-than-optimal numbers of participants, this study was closed after enrolling 
one patient. Therefore, the above statistical methods could not be applied.