QST for Chronic Pancreatitis

Recruiting at 2 trial locations

Overseen By Apsara Mishra

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Anna Evans Phillips

Disqualifiers: Pregnancy, Pancreatic surgery, others

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

Compensation: Varies

Number of Visits: 4

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to better understand pain in individuals with Chronic Pancreatitis (CP) through Quantitative Sensory Testing (QST). QST consists of tests that map pain perception and may help predict treatment responses. The trial includes various groups: those with CP, suspected CP, Sphincter of Oddi Dysfunction, and healthy individuals. It seeks participants with CP or ongoing abdominal pain lasting more than three months. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future pain management strategies.

Will I have to stop taking my current medications?

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

What prior data suggests that this technique is safe for evaluating pain patterns in chronic pancreatitis?

Research has shown that Quantitative Sensory Testing (QST) is generally safe for people. This method helps researchers understand pain by using different types of gentle stimulations. In studies involving individuals with chronic pancreatitis, most participants did not experience a significant increase in pain, and more than half did not become more sensitive to pain.

QST has also been used successfully in other pain conditions, indicating it is well-tolerated. There are no major reports of harmful side effects. However, like any test, it might cause some discomfort due to the stimulations used. Overall, QST is considered a safe way to study pain patterns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these Quantitative Sensory Tests (QST) for chronic pancreatitis because they offer a new way to understand and manage pain associated with this condition. Unlike traditional treatments, which often rely on medications to manage symptoms, QSTs aim to identify specific sensory abnormalities in patients, allowing for a more personalized treatment approach. By pinpointing how patients perceive pain, these tests could lead to tailored therapies that target the unique pain mechanisms of each individual, improving outcomes and potentially reducing the reliance on broad-spectrum pain medications.

What evidence suggests that Quantitative Sensory Testing is effective for evaluating pain patterns in Chronic Pancreatitis?

Research has shown that Quantitative Sensory Testing (QST) helps understand pain patterns in people with chronic pancreatitis (CP). In this trial, participants will undergo various QST assessments, including Quantitative Sensory Test 1, Test 2, and Test 3. Studies have found that QST can predict how well patients might respond to treatments like pregabalin, a pain relief medication. In other pain conditions, QST has identified specific causes of pain, guiding treatment choices. For CP, QST might eventually customize treatments for each patient by predicting who could benefit from certain invasive procedures. Early findings suggest that using QST could improve CP management by more accurately identifying effective therapies. ^{1 2 6 7 8}

Who Is on the Research Team?

Anna Evans-Phillips, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I have a confirmed diagnosis of chronic pancreatitis, grade 3 or 4.

Exclusion Criteria

Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.

Subjects with known pregnancy at the time of enrolment.

I have had surgery on my pancreas before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo Quantitative Sensory Testing and complete standardized questionnaires assessing pain, depression, anxiety, and quality of life

One-time

1 visit (in-person)

Follow-up Testing

Participants undergoing endoscopic or surgical therapy undergo follow-up testing at 1, 3, and 6 months post-procedure to evaluate changes in their pain profile

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quantitative Sensory Test 1
• Quantitative Sensory Test 2
• Quantitative Sensory Test 3

Trial Overview 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.

How Is the Trial Designed?

Group I: Sphincter of Oddi Dysfunction or Functional Dyspepsia Active Control 3 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 Controls Active Control 3 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 CP Active Control 3 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 CP Active Control 3 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.

Who Is Running the Clinical Trial?

Anna Evans Phillips

Lead Sponsor

Trials

1

Recruited

500+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Aalborg University

Collaborator

Trials

291

Recruited

2,520,000+

Published Research Related to This Trial

A study of 64 patients over 4 years identified that conventional audiologic tests, like pure tone and speech audiometry, are often sufficient for diagnosing pseudohypacusis, a condition where patients may falsely claim hearing loss.

For more complex cases, evoked otoacoustic emissions (EOAEs) proved to be the most effective and objective method, confirming hearing loss in 78.1% of cases, while auditory brain stem responses (ABRs) were needed in 15% of cases for further confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evaluation of pseudohypacusis: strategies and classification. Qiu, WW., Yin, SS., Stucker, FJ., et al.[2017]

In a study involving 45 normal-hearing subjects simulating hearing loss, results indicated that practice and familiarity with testing procedures improved their ability to manipulate outcomes on certain tests used to detect pseudohypacusis.

Different tests showed varying levels of susceptibility to being 'beaten' by the subjects, suggesting that some methods may be more reliable than others in accurately identifying true hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sophistication on four tests for nonorganic hearing loss. Monro, DA., Martin, FN.[2019]

Quantitative Sensory Testing (QST) is increasingly utilized in pain clinics and anesthesiology to objectively assess pain perception and analyze the nociceptive system.

Despite its growing popularity, the lack of standardized methodologies in QST makes it challenging to apply consistently in clinical practice, highlighting the need for clearer guidelines and protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Sensory Testing in pain assesment and treatment. Brief review and algorithmic management proposal. Avellanal, M., Riquelme, I., Díaz-Regañón, G.[2021]

In a study of 75 children with cognitive delays (including Down Syndrome, Autism Spectrum Disorder, Global Developmental Delay, and Cerebral Palsy), a significant incidence of hearing loss was found, particularly sensorineural hearing loss, with rates ranging from 10% to 46% depending on the diagnosis.

The average time from initial non-diagnostic behavioral audiometry to sedated Auditory Brainstem Response testing was notably long, highlighting the need for prompt sABR testing in children with severe cognitive delays to ensure timely diagnosis and treatment of hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and patterns of hearing loss in children with severe developmental delay. Trudeau, S., Anne, S., Otteson, T., et al.[2021]

In a study of 250 infants from a neonatal intensive care unit, evoked oto-acoustic emissions (EOAE) testing was found to be the most cost-effective initial screening method for hearing impairment, especially in larger populations.

Follow-up testing using auditory brain-stem response (ABR) was recommended due to its lower failure rates and ability to measure hearing thresholds, making it suitable for confirming results from EOAE tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory screening in high risk neonates: selection of a test protocol. Webb, HD., Stevens, JC.[2019]

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]

Quantitative sensory testing (QST) shows potential in identifying sensory abnormalities in conditions like diabetic neuropathy, but there is no strong evidence from well-powered studies to confirm its effectiveness for specific disorders.

Due to variability between different QST systems and the lack of consensus on reproducibility, results from one system cannot be directly compared to another, highlighting the need for standardized methodologies in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Shy, ME., Frohman, EM., So, YT., et al.[2022]

Pseudohypacusis, or non-organic hearing loss, is often misdiagnosed in children due to a lack of awareness, despite being easier to identify than in adults.

The use of otoacoustic emissions testing has improved the diagnosis of pseudohypacusis, allowing for quicker and easier identification compared to traditional audiological testing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic tools in pseudohypacusis in children. Saravanappa, N., Mepham, GA., Bowdler, DA.[2005]

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]

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]

The multicenter study involving 60 healthy subjects demonstrated that the capsaicin pain model effectively induced significant changes in quantitative sensory testing (QST) measures, indicating its utility in studying neuropathic pain.

Key findings included decreased cold detection and pain thresholds, and increased mechanical pain sensitivity on the capsaicin-treated side, with consistent results across six different research centers, supporting the reliability of QST in pain research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter assessment of quantitative sensory testing (QST) for the detection of neuropathic-like pain responses using the topical capsaicin model. Ferland, CE., Villemure, C., Michon, PE., et al.[2022]

The standardized quantitative sensory testing (QST) protocol demonstrated high reliability over a 10-week period in 22 healthy volunteers, indicating it can be a dependable tool for assessing sensory function.

Most QST parameters showed almost-perfect to substantial reliability, making it suitable for clinical trials, while also allowing for the definition of meaningful changes in sensory thresholds over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How stable are quantitative sensory testing measurements over time? Report on 10-week reliability and agreement of results in healthy volunteers. Nothnagel, H., Puta, C., Lehmann, T., et al.[2020]

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 ... Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study ...

3. 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 ( ...

4. cghjournal.org cghjournal.org/article/S1542-3565(20)31494-4/fulltext

Pancreatic QST Differentiates Chronic Pancreatitis Patients ... Quantitative sensory testing predicts pregabalin efficacy in painful chronic pancreatitis. PloS One. 2013; 8:e57963. Crossref · Scopus (106).

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0057963

Quantitative Sensory Testing Predicts Pregabalin Efficacy in ... We tested the ability of quantitative sensory testing to predict the analgesic effect of pregabalin and placebo in patients with chronic pancreatitis. Methods.

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

Pancreatic QST Differentiates Chronic Pancreatitis Patients ... P-QST showed no hyperalgesia in 91 (51%), segmental hyperalgesia in 50 (28%) and widespread hyperalgesia in 38 (21%) patients. Patients with widespread ...

7. rapm.bmj.com rapm.bmj.com/content/37/5/530

Reliability of Static and Dynamic Quantitative Sensory ... In contrast, the reliability of dynamic QST was poor (ICC, 0.01). For static QST measures, the reliability was higher for pain thresholds compared with ...

8. ctv.veeva.com ctv.veeva.com/study/pancreatic-quantitative-sensory-testing-p-qst-to-predict-treatment-response-for-pain-in-chronic-pa

Pancreatic Quantitative Sensory Testing (P-QST) to Predict ... The proposed clinical trial will evaluate the predictive capability of Pancreatic Quantitative Sensory Testing (P-QST) - a novel assessment of ...