Clinical trial NCT03799471: Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease
Official title: Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Chronic Pain
Central Sensitization
Keywords: chronic musculoskeletal pain
central hypersensitivity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: University of Otago
First posted: 2019-01-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dartmouth-Hitchcock Medical Center - IBD Center patient database.

Brief summary: This study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or older)
* Clinical diagnosis of IBD or healthy control

Exclusion Criteria: Participants with IBD (with and without MSK pain) will be excluded if they report any of the following:

* pregnancy
* current history of drug or alcohol abuse
* any condition resulting in altered sensation such as: nerve injuries, neurological conditions (e.g. stroke, multiple sclerosis, and Parkinson's disease)
* surgery within the last 3 months

Primary outcomes:
measure: Pain pressure threshold (PPT)
timeFrame: Baseline
measure: Conditioned pain modulation (CPM)
timeFrame: Baseline
measure: Temporal summation (TS)
timeFrame: Baseline
Secondary outcomes:
measure: Central sensitization inventory (CSI)
timeFrame: Baseline
measure: Abdominal pain: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a short form
timeFrame: Baseline
measure: Abdominal pain intensity: numeric rating scale
timeFrame: Baseline
measure: Health-related quality of life (HRQOL) - EQ-5D
timeFrame: Baseline
measure: Situational Catastrophizing Questionnaire (SCQ)
timeFrame: Baseline
measure: Positive and Negative Affective Schedule (PANAS)
timeFrame: Baseline
measure: 10-item Perceived Stress Scale (PSS-10)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Total comorbidity score
timeFrame: Baseline
measure: MSK pain location
timeFrame: Baseline
measure: MSK pain - PROMIS Pain Interference 4a
timeFrame: Baseline
measure: MSK pain intensity - numeric rating scale
timeFrame: Baseline
measure: Health-related quality of life (EQ-5D)
timeFrame: Baseline
measure: IBD type
timeFrame: Baseline
measure: IBD duration
timeFrame: Baseline
Other outcomes:
measure: Vibration detection threshold (VDT)
timeFrame: Baseline
measure: Semmes-Weinstein monofilament examination (SWME)
timeFrame: Baseline
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Corey A Siegel, MD
role: PRINCIPAL_INVESTIGATOR
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