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

Trial Summary

What is the purpose of this trial?

Abdominal pain in chronic pancreatitis (CP) affects up to 90% of patients during the course of their disease, and response to currently available therapies is suboptimal and unpredictable. The proposed clinical trial will evaluate the predictive capability of Pancreatic Quantitative Sensory Testing (P-QST) - a novel assessment of neurosensory phenotyping- for improvement in pain in patients with CP who are undergoing medically-indicated invasive treatment with endoscopic therapy or surgery.

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 data supports the effectiveness of the treatment Pancreatic Quantitative Sensory Testing (P-QST) for chronic pancreatitis?

The research suggests that Pancreatic Quantitative Sensory Testing (P-QST) can help identify different types of pain in chronic pancreatitis patients, which may guide more personalized pain management strategies. While it doesn't directly show pain relief, it helps understand pain better, which is a step towards effective treatment. ^{1 2 3 4 5}

How does the P-QST treatment differ from other treatments for chronic pancreatitis?

P-QST (Pancreatic Quantitative Sensory Testing) is unique because it uses a method to assess and characterize pain mechanisms in chronic pancreatitis patients, helping to identify distinct pain types and guide personalized treatment. Unlike standard treatments, it focuses on understanding individual pain sensitivity and mechanisms, which can lead to more targeted and effective pain management. ^{1 2 3 4 6}

Research Team

Anna Evans Phillips, MD, MS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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 am under 18 years old.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pancreatic QST Differentiates Chronic Pancreatitis Patients into Distinct Pain Phenotypes Independent of Psychiatric Comorbidities. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient and Disease Characteristics Associate With Sensory Testing Results in Chronic Pancreatitis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A clinically feasible method for the assessment and characterization of pain in patients with chronic pancreatitis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Reliability of static and dynamic quantitative sensory testing in patients with painful chronic pancreatitis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Rationale for and Development of the Pancreatic Quantitative Sensory Testing Consortium to Study Pain in Chronic Pancreatitis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of experimental pain from skin, muscle, and esophagus in patients with chronic pancreatitis. [2008]