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出境医 / 临床实验 / Understanding Abdominal Pain in IBD and IBS

Understanding Abdominal Pain in IBD and IBS

Study Description
Brief Summary:
Abdominal pain is a central symptom of Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). IBD is an autoimmune disease characterized by inflammation of the gastrointestinal tract. IBS does not have clear biomarkers and is diagnosed based on symptom reports. The aim of this study is to explore biopsychosocial factors which may perpetuate and/or increase the severity of pain in these conditions. The main focus will be on the role of top-down brain processes in the experience of abdominal pain.

Condition or disease
Abdominal Pain Inflammatory Bowel Diseases Irritable Bowel Syndrome

Detailed Description:

It remains unclear why a large proportion of people with inflammatory bowel disease (IBD) report ongoing abdominal pain during remission or why people with irritable bowel syndrome (IBS) develop abdominal pain. One theory is that people with chronic pain have somehow grown more sensitive.

It is assumed that such heightened sensitivity depends both on bottom-up processing and top-down processing. Bottom-up processing refers to information that is relayed to the brain along so-called afferent fibres. Top-down processing refers to feedback provided by the brain to lower areas along efferent fibres.

The investigators will (1) measure the capacity of people to inhibit pain through top-down processing, (2) test if the human pain experience is enhanced due to sustained activation of certain afferents, and (3) assess to what extent people are impacted by psychosocial inhibition and activation factors. Results of people with IBS in remission will be compared with the results of two groups of people with IBD (those with pain and those without) and the investigators will explore if their measurements differentiate between groups.

It is hypothesized that (1) IBS patients and IBD patients with abdominal pain will be less able to inhibit their pain compared to IBD patients without abdominal pain (2) IBS patients and IBD patients with abdominal pain will score higher on psychosocial inhibition factors and lower on psychosocial activation factors when compared to IBD patients without abdominal pain. (3) In the total cohort, laboratory measures of pain inhibition will correlate with self-reported psychosocial inhibition and activation factors. (4) IBS patients and IBD patients with abdominal pain will show more temporal summation compared to IBD patients without abdominal pain.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Exploring Biopsychosocial Mechanisms of Abdominal Pain in Inflammatory Bowel Disease and Irritable Bowel Syndrome
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 31, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Efficiency of inhibitory pain modulation, comparing patients with IBS or quiescent IBD [ Time Frame: January 31, 2020 ]

    Measured with Conditioned Pain Modulation test.

    Two inflatable pressure cuffs are secured around the caffs of subjects and then inflated. Pressure pain detection threshold (PDT) and pressure pain tolerance (PTT) are assessed on a subject's dominant leg. PDT is the first sensation of pain and PTT is defined as the point a subject no longer want the cuff to inflate. A VAS device allows participants to report their pain levels by moving a sliding button along a continuous line between two endpoints (0=no pain to 10=worst pain imaginable).

    After a second baseline measure on the non-dominant leg CPM is assessed: the cuff on the non-dominant leg is inflated to 70% of the subject's PTT, then after 15 seconds the cuff on the dominant leg is inflated. If pain modulation is achieved, the subject will show increased threshold and tolerance levels during CPM. The CPM-effect is defined as the difference between baseline and conditioning measurements of both PDT and PTT.


  2. Contribution of socio-demographic, clinical and psychosocial factors to the efficiency of inhibitory pain modulation [ Time Frame: January 31, 2020 ]
    Measured with a range of questionnaires, i.e.: Brief Pain Inventory Short Form (BPI), painDETECT questionnaire, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Visceral Sensitivity Index, Pain Catastrophising Scale, Cognitive and Behavioural Response to Symptoms Questionnaire, Pain Self Efficacy Questionnaire, Chronic Pain Acceptance Questionnaire-8, and Mental Health Continuum Short-Form


Secondary Outcome Measures :
  1. Pain facilitation, comparing patients with IBS and quiescent IBD [ Time Frame: January 31, 2020 ]

    Measured with Temporal Summation (TS) test.

    TS will be carried out on the dominant leg dominant. A series of 10 rapid stimuli will be given at a rate of 0.5 Hz (1-second of pressure at 1-second intervals). The cuff pressure-level of the stimuli will be determined by the pressure pain tolerance level of the subject. In each instance the subject will rate the painfulness of the stimulus using the VAS. The VAS rating for each stimulus will be relative to the painfulness of the previous stimulus in the train of stimuli, i.e. the subject does not return the VAS scale to zero after each stimulation. In other words, if the painfulness of a stimulus is more intense than the previous stimulus, the VAS scale is increased. If the painfulness of stimulus is less intense than the previous stimulus, the VAS scale is decreased. If the sensation remains the same between stimuli, then the VAS scale is not changed.



Biospecimen Retention:   Samples Without DNA
stool sample (faecal calprotectin)

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with quiescent Inflammatory Bowel Disease or Irritable Bowel Syndrome
Criteria

General inclusion criteria:

  • Aged 18 and over
  • Sufficient command of written and spoken English

IBD in remission inclusion criteria:

  • Proof of diagnosis of IBD (Crohn's disease or ulcerative colitis) for more than 6 months - - Clear indicators of remission: on faecal calprotectin (≤200 µg/g) or measurements of C-reactive protein (CRP; ≤10 mg/dl) within the last 3 months or as part of recruitment
  • No previous episodes of acute or sub-acute obstruction

IBS inclusion criteria:

  • Current diagnosis of IBS measured with Rome IV criteria
  • No serious other bowel diseases

Exclusion criteria:

  • Major abdominal surgery in the last 6 months, or 3 or more previous major abdominal surgeries
  • Pregnancy or childbirth in the last 6 months
  • Any other diagnosed medical condition that may explain abdominal pain, including but not limited to known gynaecological conditions such as endometriosis and known post-surgical adhesions
  • Any diagnosed co-morbid medical conditions associated with known neuropathy, such as diabetic neuropathy, renal neuropathy, multiple sclerosis
  • Use of opioids in the last week
  • Use of anti-depressants used as pain medication in the last month
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Danielle Huisman +442071880188 danielle.huisman@kcl.ac.uk
Contact: Reza Razavi +442078486390 reza.razavi@kcl.ac.uk

Locations
Layout table for location information
United Kingdom
Barts Health NHS Trust Not yet recruiting
London, United Kingdom
Contact: King's College Hospital NHS Foundation Trust         
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Consultant Gastroenterologist         
King's College Hospital NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Consultant Gastroenterologist         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Tracking Information
First Submitted Date July 12, 2019
First Posted Date July 16, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date May 20, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • Efficiency of inhibitory pain modulation, comparing patients with IBS or quiescent IBD [ Time Frame: January 31, 2020 ]
    Measured with Conditioned Pain Modulation test. Two inflatable pressure cuffs are secured around the caffs of subjects and then inflated. Pressure pain detection threshold (PDT) and pressure pain tolerance (PTT) are assessed on a subject's dominant leg. PDT is the first sensation of pain and PTT is defined as the point a subject no longer want the cuff to inflate. A VAS device allows participants to report their pain levels by moving a sliding button along a continuous line between two endpoints (0=no pain to 10=worst pain imaginable). After a second baseline measure on the non-dominant leg CPM is assessed: the cuff on the non-dominant leg is inflated to 70% of the subject's PTT, then after 15 seconds the cuff on the dominant leg is inflated. If pain modulation is achieved, the subject will show increased threshold and tolerance levels during CPM. The CPM-effect is defined as the difference between baseline and conditioning measurements of both PDT and PTT.
  • Contribution of socio-demographic, clinical and psychosocial factors to the efficiency of inhibitory pain modulation [ Time Frame: January 31, 2020 ]
    Measured with a range of questionnaires, i.e.: Brief Pain Inventory Short Form (BPI), painDETECT questionnaire, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Visceral Sensitivity Index, Pain Catastrophising Scale, Cognitive and Behavioural Response to Symptoms Questionnaire, Pain Self Efficacy Questionnaire, Chronic Pain Acceptance Questionnaire-8, and Mental Health Continuum Short-Form
Original Primary Outcome Measures
 (submitted: July 12, 2019)
  • Efficiency of inhibitory pain modulation, comparing patients with IBS or quiescent IBD [ Time Frame: January 31, 2020 ]
    Measured with Conditioned Pain Modulation test
  • Contribution of socio-demographic, clinical and psychosocial factors to the efficiency of inhibitory pain modulation [ Time Frame: January 31, 2020 ]
    Measured with a range of questionnaires
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
Pain facilitation, comparing patients with IBS and quiescent IBD [ Time Frame: January 31, 2020 ]
Measured with Temporal Summation (TS) test. TS will be carried out on the dominant leg dominant. A series of 10 rapid stimuli will be given at a rate of 0.5 Hz (1-second of pressure at 1-second intervals). The cuff pressure-level of the stimuli will be determined by the pressure pain tolerance level of the subject. In each instance the subject will rate the painfulness of the stimulus using the VAS. The VAS rating for each stimulus will be relative to the painfulness of the previous stimulus in the train of stimuli, i.e. the subject does not return the VAS scale to zero after each stimulation. In other words, if the painfulness of a stimulus is more intense than the previous stimulus, the VAS scale is increased. If the painfulness of stimulus is less intense than the previous stimulus, the VAS scale is decreased. If the sensation remains the same between stimuli, then the VAS scale is not changed.
Original Secondary Outcome Measures
 (submitted: July 12, 2019)
Pain facilitation, comparing patients with IBS and quiescent IBD [ Time Frame: January 31, 2020 ]
Measured with Temporal Summation test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding Abdominal Pain in IBD and IBS
Official Title Exploring Biopsychosocial Mechanisms of Abdominal Pain in Inflammatory Bowel Disease and Irritable Bowel Syndrome
Brief Summary Abdominal pain is a central symptom of Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). IBD is an autoimmune disease characterized by inflammation of the gastrointestinal tract. IBS does not have clear biomarkers and is diagnosed based on symptom reports. The aim of this study is to explore biopsychosocial factors which may perpetuate and/or increase the severity of pain in these conditions. The main focus will be on the role of top-down brain processes in the experience of abdominal pain.
Detailed Description

It remains unclear why a large proportion of people with inflammatory bowel disease (IBD) report ongoing abdominal pain during remission or why people with irritable bowel syndrome (IBS) develop abdominal pain. One theory is that people with chronic pain have somehow grown more sensitive.

It is assumed that such heightened sensitivity depends both on bottom-up processing and top-down processing. Bottom-up processing refers to information that is relayed to the brain along so-called afferent fibres. Top-down processing refers to feedback provided by the brain to lower areas along efferent fibres.

The investigators will (1) measure the capacity of people to inhibit pain through top-down processing, (2) test if the human pain experience is enhanced due to sustained activation of certain afferents, and (3) assess to what extent people are impacted by psychosocial inhibition and activation factors. Results of people with IBS in remission will be compared with the results of two groups of people with IBD (those with pain and those without) and the investigators will explore if their measurements differentiate between groups.

It is hypothesized that (1) IBS patients and IBD patients with abdominal pain will be less able to inhibit their pain compared to IBD patients without abdominal pain (2) IBS patients and IBD patients with abdominal pain will score higher on psychosocial inhibition factors and lower on psychosocial activation factors when compared to IBD patients without abdominal pain. (3) In the total cohort, laboratory measures of pain inhibition will correlate with self-reported psychosocial inhibition and activation factors. (4) IBS patients and IBD patients with abdominal pain will show more temporal summation compared to IBD patients without abdominal pain.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
stool sample (faecal calprotectin)
Sampling Method Non-Probability Sample
Study Population Patients with quiescent Inflammatory Bowel Disease or Irritable Bowel Syndrome
Condition
  • Abdominal Pain
  • Inflammatory Bowel Diseases
  • Irritable Bowel Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2019)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

General inclusion criteria:

  • Aged 18 and over
  • Sufficient command of written and spoken English

IBD in remission inclusion criteria:

  • Proof of diagnosis of IBD (Crohn's disease or ulcerative colitis) for more than 6 months - - Clear indicators of remission: on faecal calprotectin (≤200 µg/g) or measurements of C-reactive protein (CRP; ≤10 mg/dl) within the last 3 months or as part of recruitment
  • No previous episodes of acute or sub-acute obstruction

IBS inclusion criteria:

  • Current diagnosis of IBS measured with Rome IV criteria
  • No serious other bowel diseases

Exclusion criteria:

  • Major abdominal surgery in the last 6 months, or 3 or more previous major abdominal surgeries
  • Pregnancy or childbirth in the last 6 months
  • Any other diagnosed medical condition that may explain abdominal pain, including but not limited to known gynaecological conditions such as endometriosis and known post-surgical adhesions
  • Any diagnosed co-morbid medical conditions associated with known neuropathy, such as diabetic neuropathy, renal neuropathy, multiple sclerosis
  • Use of opioids in the last week
  • Use of anti-depressants used as pain medication in the last month
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Danielle Huisman +442071880188 danielle.huisman@kcl.ac.uk
Contact: Reza Razavi +442078486390 reza.razavi@kcl.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04020835
Other Study ID Numbers 253660
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators King's College London
Investigators Not Provided
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date July 2019