Understanding Abdominal Pain in IBD and IBS

NCT04020835 | Unknown

• 1 other identifier: 253660
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Abdominal Pain; Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  January 31, 2020

Secondary Outcomes (1)

• Pain facilitation, comparing patients with IBS and quiescent IBD

  January 31, 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with quiescent Inflammatory Bowel Disease or Irritable Bowel Syndrome

You may qualify if:

• Aged 18 and over
• Sufficient command of written and spoken English
• 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
• Current diagnosis of IBS measured with Rome IV criteria
• No serious other bowel diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (3)

Barts Health NHS Trust

London, United Kingdom

NOT YET RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool sample (faecal calprotectin)

MeSH Terms

Conditions

Abdominal Pain; Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases

Central Study Contacts

Danielle Huisman

CONTACT

+442071880188; danielle.huisman@kcl.ac.uk

Reza Razavi

CONTACT

+442078486390; reza.razavi@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: May 20, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

GB (3)