Condition or disease |
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Abdominal Pain Inflammatory Bowel Diseases Irritable Bowel Syndrome |
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 |
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 |
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.
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.
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 |
General inclusion criteria:
IBD in remission inclusion criteria:
IBS inclusion criteria:
Exclusion criteria:
Contact: Danielle Huisman | +442071880188 | danielle.huisman@kcl.ac.uk | |
Contact: Reza Razavi | +442078486390 | reza.razavi@kcl.ac.uk |
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 |
Tracking Information | |||||||||
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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 |
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Original Primary Outcome Measures |
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Change History | |||||||||
Current Secondary Outcome Measures |
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.
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Original Secondary Outcome Measures |
Pain facilitation, comparing patients with IBS and quiescent IBD [ Time Frame: January 31, 2020 ] Measured with Temporal Summation test
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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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples Without DNA Description:
stool sample (faecal calprotectin)
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients with quiescent Inflammatory Bowel Disease or Irritable Bowel Syndrome | ||||||||
Condition |
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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. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
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:
IBD in remission inclusion criteria:
IBS inclusion criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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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 |