← Back to Search

QST for Chronic Pancreatitis

N/A

Recruiting

Led By Anna Evans-Phillips, MD

Research Sponsored by Anna Evans Phillips

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).

Subjects have prior diagnosis of Type 1 or Type 2 Sphincter of Oddi Dysfunction (subjects with biliary pain accompanied by biochemical features of transient biliary tract obstruction including elevated transaminases, alkaline phosphatase, or conjugated bilirubin; may also be accompanied by biliary or pancreatic ductal dilation on imaging)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study Summary

This trial will use a new technique, quantitative sensory testing (QST), to map pain patterns in people with chronic pancreatitis (CP). QST has the potential to improve treatment for CP and may eventually be able to predict response to CP therapies.

Who is the study for?

This trial is for adults with chronic pancreatitis who experience abdominal pain of pancreatic origin, rated above 3 on the pain scale. They must have had this pain frequently over the last three months and may have a history of surgical intervention on their pancreas. Pregnant individuals or those unable to distinguish their pancreatic pain from other types are excluded.Check my eligibility

What is being tested?

The study tests Quantitative Sensory Testing (QST), which uses standardized stimulations to map out patterns of chronic pain in patients with Chronic Pancreatitis. The goal is to improve treatment strategies and potentially predict responses to invasive therapies.See study design

What are the potential side effects?

As QST involves sensory testing rather than medication or surgery, it's not expected to cause typical side effects. However, participants might experience discomfort during the testing process due to the nature of sensory stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have chronic abdominal pain suspected to be from the pancreas, rated above 3 on a scale of 0-10.

Select...

I have been diagnosed with a type of Sphincter of Oddi Dysfunction.

Select...

I either have no pancreatic disease and no abdominal pain, or I have been diagnosed with functional dyspepsia.

Select...

I am 18 years old or older.

Select...

I can tell my pancreatitis pain apart from other chronic pains.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one-time baseline testing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one-time baseline testing

This trial's timeline: 3 weeks for screening, Varies for treatment, and one-time baseline testing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Pattern Assessment as assessed by the combination of Temporal Summation score, Sensitization score, and Conditioned Pain Modulation score

Secondary outcome measures

Change in Mean Pain score

Trial Design

4Treatment groups

Active Control

Group I: Sphincter of Oddi Dysfunction or Functional DyspepsiaActive Control3 Interventions

Patients with Sphincter of Oddi Dysfunction Type 1 or Type 2, or who have a prior diagnosis of Functional Dyspepsia. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Group II: Healthy ControlsActive Control3 Interventions

Subjects with no pancreatic disease and no abdominal pain. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Group III: Suspected CPActive Control3 Interventions

Suspected Chronic Pancreatitis patients. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires.

Group IV: Definite CPActive Control3 Interventions

Definite Chronic Pancreatitis patients. Subjects will undergo the following Interventions: Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3, They will also fill out validated questionnaires. A subset of these patients who undergo endotherapy as per clinical recommendation from clinical provider independent of this study will be followed for 6 months after their clinical intervention for repeat Quantitative Sensory Test 1, Quantitative Sensory Test 2, and Quantitative Sensory Test 3 and questionnaires.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anna Evans PhillipsLead Sponsor

Johns Hopkins UniversityOTHER

2,260 Previous Clinical Trials

14,820,280 Total Patients Enrolled

14 Trials studying Chronic Pain

1,586 Patients Enrolled for Chronic Pain

Aalborg UniversityOTHER

273 Previous Clinical Trials

2,467,253 Total Patients Enrolled

11 Trials studying Chronic Pain

601,308 Patients Enrolled for Chronic Pain

Media Library

Sphincter of Oddi Dysfunction or Functional Dyspepsia Clinical Trial Eligibility Overview. Trial Name: NCT03434392 — N/A

Chronic Pain Research Study Groups: Sphincter of Oddi Dysfunction or Functional Dyspepsia, Healthy Controls, Suspected CP, Definite CP

Chronic Pain Clinical Trial 2023: Sphincter of Oddi Dysfunction or Functional Dyspepsia Highlights & Side Effects. Trial Name: NCT03434392 — N/A

Sphincter of Oddi Dysfunction or Functional Dyspepsia 2023 Treatment Timeline for Medical Study. Trial Name: NCT03434392 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of individuals enrolled in this medical experiment?

"Indeed, the information found on clinicaltrials.gov confirms that registration for this medical experiment is ongoing since its initiation on October 24th 2017 and last update in September 8th 2022. The researchers seek 500 participants to be recruited from 3 distinct sites."

Answered by AI

Is this medical experiment still seeking participants?

"Clinicaltrials.gov indicates that this trial is seeking suitable participants. It was initially made public on October 24th 2017 and the most recent update was recorded in September 2022."

Answered by AI