P-QST to Predict Pain Treatment Response in Chronic Pancreatitis

(P-QST Trial)

Recruiting at 2 trial locations

Overseen By Jacqueline Noel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Chronic pain, Prior pancreatic surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Varies based on treatment

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new test, Pancreatic Quantitative Sensory Testing (P-QST), can predict the effectiveness of pain treatments for chronic pancreatitis patients. Chronic pancreatitis often leads to severe abdominal pain, and current treatments may not always be effective. The trial focuses on individuals already scheduled for medical procedures, such as endoscopic therapy or surgery, to relieve pain from pancreatic blockages. Those diagnosed with chronic pancreatitis and set for such procedures might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future pain management strategies for chronic pancreatitis.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Pancreatic Quantitative Sensory Testing (P-QST) is safe?

Research shows that Pancreatic Quantitative Sensory Testing (P-QST) helps researchers understand pain patterns in people with chronic pancreatitis. It uses a series of standard tests to assess pain responses. P-QST is neither a drug nor a surgical procedure, so it lacks the usual side effects associated with those treatments.

Studies have found that P-QST can differentiate between various pain experiences in people with chronic pancreatitis, aiding in personalized treatment. As a testing method rather than a treatment, P-QST does not present direct safety concerns like medications or surgeries do.

In summary, P-QST is a well-tolerated assessment tool that offers a new way to understand and predict pain without the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pancreatic Quantitative Sensory Testing (P-QST) because it's a unique approach to understanding pain in chronic pancreatitis. Unlike standard treatments that mainly focus on relieving duct obstruction through endoscopic therapy or surgery, P-QST aims to predict how patients will respond to these invasive treatments by assessing their sensory responses beforehand. This personalized insight could lead to more targeted and effective pain management strategies, potentially improving outcomes and reducing unnecessary procedures for patients.

What evidence suggests that Pancreatic Quantitative Sensory Testing (P-QST) is effective for predicting pain treatment response in chronic pancreatitis?

Research has shown that Pancreatic Quantitative Sensory Testing (P-QST), which participants in this trial will undergo, can help predict how well patients with chronic pancreatitis (CP) respond to pain treatments. This test uses a series of standard stimulations to identify pain patterns and understand pain mechanisms in CP patients. Early findings suggest that recognizing these patterns can assist doctors in selecting the best treatment options for pain relief. The trial aims to create a model using P-QST results to predict which patients might experience significant pain improvement after procedures like surgery or endoscopic therapy. This approach could make pain management more effective and personalized for those with CP. ^{1 2 4 5 6}

Who Is on the Research Team?

Anna Evans Phillips, MD, MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic pancreatitis (CP) experiencing pain, who are scheduled for specific invasive treatments to clear blockages in the pancreatic duct. Eligible patients haven't had endoscopic therapy in the past year and have no other chronic pain conditions or prior pancreatic surgery.

Inclusion Criteria

I am an adult with chronic pancreatitis, getting treatment to relieve duct blockage.

I have had surgery to drain my pancreas.

I have undergone or will undergo a procedure to remove blockages in my pancreas.

Exclusion Criteria

I have undergone endoscopic therapy in the last year.

I have had surgery on my pancreas before.

I have chronic pain not caused by chronic pancreatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo Pancreatic Quantitative Sensory Testing (P-QST) to assess baseline nociceptive patterns before invasive treatment

1 week

1 visit (in-person)

Treatment

Participants receive medically-indicated invasive treatment with endoscopic therapy or surgery

Varies based on treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pancreatic Quantitative Sensory Testing (P-QST)

Trial Overview The study tests Pancreatic Quantitative Sensory Testing (P-QST), a new method to predict if patients with CP will feel less pain after undergoing certain medical procedures like endoscopy or drainage surgeries.

How Is the Trial Designed?

Group I: Pancreatic Quantitative Sensory Testing (P-QST) Experimental Treatment 3 Interventions

Definite Chronic Pancreatitis patients undergoing decompressive invasive treatments (endoscopic therapy or surgery) to relieve main pancreatic duct obstruction due to stones and/or stricture for management of pain will undergo P-QST prior to clinically-indicated invasive treatment.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Patients with chronic pancreatitis (CP) showed impaired pain modulation compared to healthy controls, indicating that their ability to manage pain is compromised, which was measured using quantitative sensory testing (QST).

The study found that severe clinical pain in CP patients was linked to reduced conditioned pain modulation (CPM) function, suggesting that improving pain modulation could be an important focus for treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Disease Characteristics Associate With Sensory Testing Results in Chronic Pancreatitis. Kuhlmann, L., Olesen, SS., Grønlund, D., et al.[2020]

A new method for assessing pain mechanisms in chronic pancreatitis (CP) patients was validated using quantitative sensory testing (QST) in a study of 182 participants, including 60 patients with painful CP and 122 healthy controls.

The study found that 50% of CP patients had normal pain processing, while 23% showed segmental sensitization and 27% had widespread sensitization, indicating different underlying pain mechanisms that could guide treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinically feasible method for the assessment and characterization of pain in patients with chronic pancreatitis. Phillips, AE., Faghih, M., Kuhlmann, L., et al.[2020]

In a study of 179 patients with chronic pancreatitis, pancreatic quantitative sensory testing (P-QST) effectively categorized patients into distinct pain phenotypes, revealing that those with widespread hyperalgesia experienced higher pain intensity and lower quality of life.

P-QST serves as a promising tool for unbiased pain assessment in chronic pancreatitis, as it differentiates pain types without being influenced by psychiatric comorbidities, which were similar across all patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic QST Differentiates Chronic Pancreatitis Patients into Distinct Pain Phenotypes Independent of Psychiatric Comorbidities. Faghih, M., Phillips, AE., Kuhlmann, L., et al.[2023]

Static quantitative sensory testing (QST) demonstrated high test-retest reliability in measuring pain thresholds in patients with visceral pain from chronic pancreatitis, particularly for pressure pain thresholds (ICC 0.74) and electrical sensation thresholds (ICC 0.66).

Dynamic QST, which assesses conditioned pain modulation, showed poor reliability (ICC 0.01), indicating that while static measures are consistent over time, dynamic measures may not be dependable for tracking pain processing changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of static and dynamic quantitative sensory testing in patients with painful chronic pancreatitis. Olesen, SS., van Goor, H., Bouwense, SA., et al.[2019]

The development of the Pancreatic Quantitative Sensory Testing (P-QST) nomogram allows for better characterization of pain in chronic pancreatitis (CP) patients, revealing that those with widespread hyperalgesia experience higher pain intensity and lower quality of life.

The P-QST Consortium aims to standardize pain assessment in CP, which could lead to more personalized pain management strategies based on objective sensory testing results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for and Development of the Pancreatic Quantitative Sensory Testing Consortium to Study Pain in Chronic Pancreatitis. Phillips, AE., Faghih, M., Singh, VK., et al.[2023]

Patients with chronic pancreatitis (CP) showed reduced sensitivity to mechanical pain stimuli compared to healthy controls, indicating a potential alteration in pain perception mechanisms, while their responses to thermal and electrical stimuli were similar to controls.

The study revealed a higher degree of central sensitization in CP patients, as evidenced by a larger area of referred pain and a greater difference in pain response to repeated stimuli, suggesting that treatments targeting central hyperexcitability and neuroplastic changes may be beneficial for managing pain in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of experimental pain from skin, muscle, and esophagus in patients with chronic pancreatitis. Dimcevski, G., Staahl, C., Andersen, SD., et al.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10961514/

Pancreatic quantitative sensory testing to predict treatment ... The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03434392

QST Study: Predicting Treatment Response in Chronic ... In this study will be used to elucidate pain patterns in patients with Chronic Pancreatitis (CP). QST uses a specific series of standardized stimulations to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04996628?term=AREA%5BConditionSearch%5D(Pancreatitis)%20AND%20AREA%5BBasicSearch%5D(Johns%20Hopkins)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20ENROLLING_BY_INVITATION%20OR%20ACTIVE_NOT_RECRUITING)&rank=9

Pancreatic Quantitative Sensory Testing (P-QST) to Predict ... Abdominal pain in chronic pancreatitis (CP) affects up to 90% of patients during the course of their disease, and response to currently available therapies ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38514147/

Pancreatic quantitative sensory testing to predict treatment ... We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1424390319307884

A clinically feasible method for the assessment and ... We present a clinically feasible method for the assessment and characterization of pain mechanisms in patients with CP based on quantitative sensory testing ( ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356520314944

Pancreatic QST Differentiates Chronic Pancreatitis Patients ... P-QST may serve as a novel unbiased pain assessment tool in CP as it categorizes patients into distinct pain phenotypes independent of their psychiatric ...