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Pain Processing and Chronic Pain in Humans: Exploring Genetic Factors and Biomarkers

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ClinicalTrials.gov Identifier: NCT02383342
Recruitment Status : Recruiting
First Posted : March 9, 2015
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Pain is the most frequent cause of suffering and disability in society. Despite considerable involvement of genetic factors in pain sensation and sensitivity, the individual genes involved remain largely unidentified.

Knowledge of genetic factors,their phenotypic expression in pain processing, and their link to neuronal correlates can improve our understanding of pain aetiology and the processes involved in pain perception and chronification. In addition, they can serve as biomarkers to predict chronic pain development and progression in individual patients and help early individual treatment adaptation.


Condition or disease
Chronic Pain

Detailed Description:

Pain is the most frequent cause of suffering and disability in society. Chronic pain seriously impairs quality of life of millions of people worldwide. 10-50% of surgical patients report chronic pain after surgery; up to 10% report severe pain. Thus, chronic pain is a significant medical and financial burden to society.

Despite considerable involvement of genetic factors in pain sensation and sensitivity, individual genes involved remain largely unidentified. Knowledge of genetic factors, their phenotypic expression in pain processing, and their link to neuronal correlates can improve understanding of pain aetiology and processes involved in pain perception and chronification. Also, they can serve as biomarkers to predict chronic pain development and progression in patients and help early individual treatment adaptation.

In this study we will establish a prospective database and biobank of patients undergoing elective major surgery. Using data from the database and biobank, we will identify genetic factors contributing to development of chronic pain after surgery. In addition, markers of pain modulation and chronification at gene expression and protein levels, and phenotypic measures of pain processing including neuroimaging features will be studied.

Over a period of 10 years we will prospectively include up to 10,000 patients visiting the hospital for elective major surgery. Data defining participants demographics, medical history and questionnaire data will be collected and stored in dedicated databases. Additional details (surgery and perioperative management, pain processing phenotypes and surgical and pain outcomes) will be stored. Besides Electroencephalography and/or magnetoencephalography, Magnetic Resonance Imaging will be performed on a subgroup (n=70).


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Pain Processing and Chronic Pain in Humans: Exploring Genetic Factors and Biomarkers
Actual Study Start Date : May 12, 2015
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




Primary Outcome Measures :
  1. Number of participants with a genetic case for chronic pain (Visual Analog Scale). [ Time Frame: 2 years ]
    Number of participants with a genetic cause for chronic pain (Visual Analog Scale). Genes/genetic variants will be identified with technologies including genome wide association studies and next generation sequencing.

  2. Number of participants that will develop chronic pain (Visual Analog Scale) at six, twelve and twenty-four months after surgery. [ Time Frame: 2 years ]
    Number of participants that will develop chronic pain at six, twelve and twenty-four months after surgery. Chronic pain is defined as pain lasting for more than three months based on a visual analog scale.


Secondary Outcome Measures :
  1. Number of patients with with basal pain (quantitative sensory testing) that will develop chronic pain after surgery (Visual Analog Scale) [ Time Frame: 2 years ]
    Number of participants with basal pain that will develop chronic pain at six, twelve and twenty-four months after surgery. Chronic pain is defined as pain lasting for more than three months based on a visual analog scale. The quantative sensory test includes tests for pain tolerance and pain modulation.

  2. Number of participants with chronic pain that have personality factors measured with NEO-FFI. [ Time Frame: 2 years ]
  3. Number of participants with chronic pain that have personality factors measured with co-morbid psychopathology (MINI). [ Time Frame: 2 years ]
  4. Number of participants with chronic pain that have an alcohol use disorder (measured with the alcohol use disorder identification test (AUDIT)). [ Time Frame: 2 years ]
  5. Number of participants with chronic pain that have a drug addiction (measured with the Drug Addiction Screening Test (DAST)). [ Time Frame: 2 years ]
  6. Number of participants with chronic pain that have a childhood trauma (measured with the Childhood Trauma Questionnaire (CTQ)) [ Time Frame: 2 years ]
  7. Number of participants with specific RNA profiles at baseline that develop chronic pain (Visual Analog Scale) after surgery. [ Time Frame: 2 years ]
    RNA levels (at baseline) will be determined in persons with and without chronic pain, to identify genes that predict to the development of chronic pain. Chronic pain is defined as pain lasting for more than three months based on a visual analog scale.

  8. Number of participants with specific protein profiles at baseline that develop chronic pain (Visual Analog Scale) after surgery. [ Time Frame: 2 years ]
    Protein levels (at baseline) will be determined in persons with and without chronic pain, to identify genes that predict to the development of chronic pain. Chronic pain is defined as pain lasting for more than three months based on a visual analog scale.

  9. Number of patients with different pain processing based on EEG. [ Time Frame: 2 years ]
    A subset of the patients (n=125) will undergo EEG measurements during painful and non-painful stimuli to investigate pain processing in the brain. Event Related Potentials (ERPs) for pain processing will be recorded to determine how pain is processed in the brain.

  10. Number of patients with pain related differences based on MRI. [ Time Frame: 2 years ]
    A subset of the patients (n=125) will undergo MRI measurements.

  11. Number of patients with specific demographic factors that develop chronic pain after surgery. [ Time Frame: 2 years ]
    Questionaires will be used to collect demographic information ( age, gender, BMI) and pain related factors (history of pain, pain medication, medical history, degree of preoperative neuropathic pain, PSQ/pain questionnaire). These factors will be investigated for their relation with the developmen of chronic pain after surgery.

  12. Number of participants with a genetic case for pain sensitivity (measured with QST). [ Time Frame: 2 years ]
    Genes/genetic variants will be identified with technologies including genome wide association studies and next generation sequencing.

  13. Number of participants with a genetic case for different pain modulation (measured with QST). [ Time Frame: 2 years ]
    Genes/genetic variants will be identified with technologies including genome wide association studies and next generation sequencing.


Biospecimen Retention:   None Retained
Blood for DNA, RNA and serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients undergoing elective major surgery at Radboud university medical center (Nijmegen, The Netherlands) in the categories 1) extremities, 2) extra-abdominal, 3) intra-abdominal, 4) intrathoracic, 5) extrathoracic are eligible for participation. Patients will be recruited prospectively and consecutively via the anaesthetic preoperative outpatients' clinic.
Criteria

Inclusion Criteria:

Patients:

  • Ages 18 - 80 years, ASA score 1-3, Caucasian ethnicity, consenting, planned surgery, categories of surgery named above, able to understand and perform QST paradigms, able to understand and answer questionnaires.

Participants EEG-experiment:

  • Additionally to the former criteria: no psychiatric or neurological diseases, no use of drugs, normal or corrected to normal vision.

Participants MRI measurements:

  • In addition to the criteria mentioned above, the participants should be able to undergo MRI. Participants are excluded in case they are claustrophobic or carry metal in their body, according to the general procedures and regulations of the Donders Centre for Cognitive Neuroimaging.

Exclusion Criteria:

  • Non-consent, non-Caucasian ethnicity, inability to give consent, neurological and psychiatric disease interfering with QST and questionnaires, unplanned and emergency surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383342


Contacts
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Contact: Marieke Coenen, PhD. marieke.coenen@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Marieke Coenen, PhD         
Sponsors and Collaborators
Radboud University
Investigators
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Study Director: Han G Brunner, Prof. PhD. Radboud University
Principal Investigator: Barbara Franke, Prof. PhD. Radboud University
Principal Investigator: Marieke JH Coenen, PhD. Radboud University
Principal Investigator: Oliver HG Wilder-Smith, PhD. Radboud University
Study Chair: Gert Jan Scheffer, Prof. PhD. Radboud University

Additional Information:

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02383342     History of Changes
Other Study ID Numbers: NL26908.091.12
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: June 2017

Keywords provided by Radboud University:
Pain Processing
Genetic Factors
Biomarkers

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms