Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease

August 25, 2019 updated by: Corey Siegel, Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Dartmouth-Hitchcock Medical Center - IBD Center patient database.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
IBD with MSK pain
IBD patients with self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, MSK pain features, co-morbidity, and IBD features
IBD without MSK pain
IBD patients without self-reported MSK pain. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, co-morbidity, and IBD features
Healthy Controls
Healthy controls. No intervention. Participants will be assessed once regarding: somatosensory functioning, psychological features, and co-morbidity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain pressure threshold (PPT)
Time Frame: Baseline

PPT will be assessed using an electronic handheld algometer (Wagner Force One™ FDIX) in: 1) low back (local), and 2) contralateral tibialis anterior. Individuals in "IBD with MSK pain" group will undergo an additional PPT assessment related to the region identified as their "main" area of MSK pain.

PPT will be assessed by a series of 3 ascending stimulus intensities given as a slowly increasing ramp (50 kilopascal (kPa/s)) from 0 to a maximum pressure of 1000 kPa. Pressure corresponding to the moment when participants identify that the sensation of pressure alone changing to one of pressure and pain, will be recorded for each trial. PPT for each region will be described as the mean of three trials in kPa. Decreased values indicates hypersensitivity of the nervous system.
Baseline
Conditioned pain modulation (CPM)
Time Frame: Baseline

CPM in the present study includes: PPT of tibialis anterior (test stimulus) and cold pressor test (CPT) to the contralateral hand (conditioning stimulus).

PPT will be performed and recorded as descried above prior to and immediately following CPT.

CPT: Hand will be submerged in an ice bath with the temperature maintained below 3°C for a maximum of 2 minutes. Participants will withdraw their hand when the pain perceived becomes intolerable or 2 minute maximum is reached. Participants will give a numeric pain rating (0-100) at the time of hand removal. Total immersion time (minutes:seconds) and pain rating will be recorded for CPT.

CPM (primary outcome) will be defined as the absolute numerical difference of PPT after minus before the CPT, with positive values indicating successful pain modulation.
Baseline
Temporal summation (TS)
Time Frame: Baseline
Mechanical TS in the present study will be assessed by a wind-up-ratio (WUR) of the volar aspect of the non-dominant arm using a Semmes-Weinstein monofilament (no. 6.45). The perceived intensity of a single stimulus will be compared with that of a series of 10 repetitive stimuli of the same physical intensity. Participants will be asked to give a pain rating for the single stimulus and a pain rating for the series of 10 stimuli as a whole, using a '0-100' numerical rating scale. This procedure will be repeated for three trials, with 1 minute between trials, and performed at different areas of the volar forearm for each trial. The mean pain rating of the 10 series divided by the mean pain rating of the single stimuli will be calculated as WUR. Higher scores indicate greater mechanical TS, indicating an increase in central sensitivity or facilitation.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central sensitization inventory (CSI)
Time Frame: Baseline
CSI is a self-report questionnaire indicating the presence of symptoms related to central sensitization syndromes. CSI consists of 25 statements where each statement is evaluated using a 5 point like scale with Never (0), Rarely (1), Sometimes (2), Often (3), and Always (4). This results in a cumulative score of 100. Scores equal to or greater than 40 indicate the likelihood of central sensitization.
Baseline
Abdominal pain: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a short form
Time Frame: Baseline
Positive findings for abdominal pain interference, include: mild (50-59), moderate (60-69), or severe (≥70).
Baseline
Abdominal pain intensity: numeric rating scale
Time Frame: Baseline
Numeric rating scales recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10).
Baseline
Health-related quality of life (HRQOL) - EQ-5D
Time Frame: Baseline
The EQ-5D questionnaire descriptive system comprises five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each one with five possible levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5); as well as a visual analogue scale ranging from 0 to 100 with higher scores indicating 'best health'.
Baseline
Situational Catastrophizing Questionnaire (SCQ)
Time Frame: Baseline
SCQ asks participants to reflect on any pain experienced during CPM testing, and to indicate the degree to which they experienced each of 13 thoughts or feelings during this experience, on 5-point Likert scales ranging from (0) not at all to (4) all the time. Total scores range from 0 to 24, with higher score representing greater pain catastrophizing.
Baseline
Positive and Negative Affective Schedule (PANAS)
Time Frame: Baseline
This questionnaire includes words describing 10 positive and 10 negative emotions, and requires participants to indicate on a Likert scale (1-5) the extent for which they felt each emotion during the previous week, with higher sub-scores represent greater negative or positive affect styles, respectively.
Baseline
10-item Perceived Stress Scale (PSS-10)
Time Frame: Baseline
The PSS-10 evaluates the degree to which individuals believe their life has been unpredictable, uncontrollable, and overloaded during the previous month, using a Likert scale (0-4) for each item, with higher scores representing greater perceived stress.
Baseline
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline
Scores for each subscale range from 0 to 21, with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.
Baseline
Total comorbidity score
Time Frame: Baseline
Total comorbidity scores will be calculated as numerical disease counts using health conditions identified on the Self-Administered Comorbidity Questionnaire, a 20-item extraintestinal manifestation (EIM) checklist developed from multiple EIM investigations, and conditions identified on the central sensitization inventory (CSI) (part B). Scores range from 0 to 39 with higher scores indicating greater comorbidity.
Baseline
MSK pain location
Time Frame: Baseline
Pain location will be recorded regionally (n=47) using a body diagram. Individuals with generalized pain will be categorically (yes/no) distinguished from those with regional pain using the modified widespread pain criterion which requires having pain in 4 out of 5 pain regions (4 quadrants plus axial pain).
Baseline
MSK pain - PROMIS Pain Interference 4a
Time Frame: Baseline
Positive findings for the PROMIS Pain Interference 4a, include: mild (50-59), moderate (60-69), or severe (≥70).
Baseline
MSK pain intensity - numeric rating scale
Time Frame: Baseline
Numeric rating scales for pain intensity will be recorded for worst, average, and current pain levels, with positive findings as mild (1-4), moderate (5-6), or severe (7-10)
Baseline
Health-related quality of life (EQ-5D)
Time Frame: Baseline
EQ-5D is a standardized instrument for measuring of health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each scored on a 5-point Likert scales ranging from (0) no problem to (4) severe. The EQ VAS records the patient's self-rated health on a 0 to 100 vertical visual analogue scale, with higher scores representing better health-related quality of life.
Baseline
IBD type
Time Frame: Baseline
IBD subtype recorded from medical charts as Crohn's disease, ulcerative colitis, or unspecified IBD.
Baseline
IBD duration
Time Frame: Baseline
Time from initial IBD diagnosis - recorded from medical charts in years.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vibration detection threshold (VDT)
Time Frame: Baseline
VDT will be assessed using a Rydel-Seiffer graded tuning fork (64 Hz, 8/8 scale) placed over bony prominences (styloid process of the ulna and medial malleolus), bilaterally. Participants will verbally indicate the moment they can no longer feel the sensation of vibration, and the value (1-8) will be recorded. VDT of each site will be described as the mean of three trials. Lower scores indicate decreased thresholds and possible peripheral neuropathy.
Baseline
Semmes-Weinstein monofilament examination (SWME)
Time Frame: Baseline
SWME of the upper limb will be performed using a 4.56 (4 g) monofilament at six locations divided over the palm and fingers, bilaterally. SWME of the lower limb will be performed using a 5.07 (10 g) monofilament at the pulp of the great toe, as well as the first, third, and fifth metatarsal heads, bilaterally. Participants will confirm (recorded as yes/no) application of the stimulus at each location. Incorrect response at any location indicates possible peripheral neuropathy.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

University of Otago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

July 19, 2019

Study Completion (Actual)

July 19, 2019

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W19040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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