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?

Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and 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 map the pain system. QST has the potential to change and improve the treatment paradigm for patients with CP and may eventually be able to predict response to invasive CP therapies.

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.

Is Quantitative Sensory Testing (QST) safe for humans?

The safety of Quantitative Sensory Testing (QST) has been evaluated by the American Academy of Neurology, which assessed its clinical utility, efficacy, and safety, indicating that it is generally considered safe for use in humans. ^{1 2 3 4 5}

Is the treatment in the trial titled 'QST for Chronic Pancreatitis' a promising treatment?

The provided research articles do not contain information about the trial titled 'QST for Chronic Pancreatitis' or its treatment, so I cannot determine if it is promising based on this data. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Quantitative Sensory Testing (QST) for Chronic Pancreatitis?

Quantitative Sensory Testing (QST) helps understand pain sensitivity and mechanisms in chronic pancreatitis, which can guide treatment decisions. It has been used to differentiate pain types in patients and is a common tool in pain clinics to objectively assess pain perception. ^{1 2 5 11 12}

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

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]

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 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]

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]

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]

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 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]

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 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]

Citations

1. New Zealand 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. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

Quantitative Sensory Testing in pain assesment and treatment. Brief review and algorithmic management proposal. [2021]

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

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

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. [2022]

7. United States 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. [2022]

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

Current evaluation of pseudohypacusis: strategies and classification. [2017]

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

Diagnosis and patterns of hearing loss in children with severe developmental delay. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Auditory screening in high risk neonates: selection of a test protocol. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic tools in pseudohypacusis in children. [2005]

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

Effects of sophistication on four tests for nonorganic hearing loss. [2019]