Abdominal Pain
Conditions
Brief summary
To conduct a pilot study to evaluate the effects of new GES programming settings on abdominal pain in patients with gastroparesis and existing GES devices, whose abdominal pain has so far been refractory to drugs and/or devices.
Detailed description
Eligible patients will undergo detailed pain assessments as well as non-invasive physiologic assessment. Patients existing GES devices will be reprogrammed to new setting for 4 week and their GI symptoms including pain will be evaluated by a daily diary. At the end of 4 weeks detailed pain assessments and noninvasive physiologic assessments will be repeated.
Interventions
DEVICEEnterra
To measure validated and subjective pain scores among patients with an existing GES device, and who have a trial of new settings directed at abdominal pain and compare their pain scores to each patient baseline symptoms, done with their previous GES settings.
Sponsors
University of Louisville
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Should be able to give informed consent for the study * Has Enterra GES device in place for at least 2 months * Continue to have moderate to severe abdominal pain on at least one pain questionnaire or \>5 score (on a scale of 0-10 for pain) on the VAS questionnaire for at least 2 months. * Abdominal pain should be either persistent; for example, daily for at least \>1 hour, be chronic for \>2 months, and refractory to original Enterra GES settings
Exclusion criteria
* Unable to provide informed consent * Pregnancy * Any other active health problems that would render patient unable to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain | 4 weeks | Abdominal Pain by Brief Pain Inventory. The values are 0-10, with 10 being worse outcome. |
Countries
United States
Outcome results
None listed