Abdominal PainNCT04020835
Understanding Abdominal Pain in IBD and IBS
An observational study of Abdominal Pain and Inflammatory Bowel Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain, Inflammatory Bowel Diseases, Irritable Bowel Syndrome
- How many people
- 90 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 20 May 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with quiescent Inflammatory Bowel Disease or Irritable Bowel Syndrome
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Barts Health NHS Trust
London
King's College Hospital NHS Foundation Trust
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Consultant Gastroenterologist
- Not yet recruiting
King's College Hospital NHS Foundation Trust
London
Consultant Gastroenterologist
About this study
Official title: Exploring Biopsychosocial Mechanisms of Abdominal Pain in Inflammatory Bowel Disease and Irritable Bowel Syndrome
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.
Read the 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.
- Medical subject headings
- Abdominal Pain, Inflammatory Bowel Diseases, Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of inhibitory pain modulation, comparing patients with IBS or quiescent IBD
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: January 31, 2020
Contribution of socio-demographic, clinical and psychosocial factors to the efficiency of inhibitory pain modulation
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
Measured: January 31, 2020
Secondary outcomes (1)
Pain facilitation, comparing patients with IBS and quiescent IBD
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.
Measured: January 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start20 May 2019
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020835
- Sponsor's protocol ID
- 253660
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Biopsychosocial Mechanisms of Abdominal Pain in Inflammatory Bowel Disease and Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04020835
- Acronym / sponsor ID
- 253660
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with quiescent Inflammatory Bowel Disease or Irritable Bowel Syndrome
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Pain facilitation, comparing patients with IBS and quiescent IBD
Time frame: January 31, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain and Inflammatory Bowel Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Huisman (+442071880188, danielle.huisman@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of inhibitory pain modulation, comparing patients with IBS or quiescent IBD (time frame: January 31, 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.