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

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ClinicalTrials.gov Identifier: NCT03799471
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
University of Otago
Information provided by (Responsible Party):
Corey Siegel, Dartmouth-Hitchcock Medical Center

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.

Condition or disease
Inflammatory Bowel Diseases Chronic Pain Central Sensitization

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

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.



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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'.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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).

  12. 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)

  13. 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.

  14. IBD type [ Time Frame: Baseline ]
    IBD subtype recorded from medical charts as Crohn's disease, ulcerative colitis, or unspecified IBD.

  15. IBD duration [ Time Frame: Baseline ]
    Time from initial IBD diagnosis - recorded from medical charts in years.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Dartmouth-Hitchcock Medical Center - IBD Center patient database.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799471


Contacts
Contact: Carrie :L Falling, BPhty(Hons) +6421558513 carrie.falling@postgrad.otago.ac.nz
Contact: Jessica I Chevalier 603-653-9033 Jessica.I.Chevalier@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756-0001
Contact: Carrie L Falling, BPhty(Hons)    642-155-8513    carrie.falling@postgrad.otago.ac.nz   
Contact: Jessica I Chevalier    603-653-9033    Jessica.I.Chevalier@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
University of Otago
Investigators
Principal Investigator: Corey A Siegel, MD Dartmouth-Hitchcock Medical Center

Publications:
Falling C, Stebbings S, Baxter GD, Gearry RB, Mani R. Profile of musculoskeletal pain in patients with inflammatory bowel disease: a study protocol for assessing the multidimensional experience of self-reported pain. Physical Therapy Reviews. 2018:1-9.

Responsible Party: Corey Siegel, Section Chief, Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03799471     History of Changes
Other Study ID Numbers: W19040
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corey Siegel, Dartmouth-Hitchcock Medical Center:
chronic musculoskeletal pain
central hypersensitivity

Additional relevant MeSH terms:
Chronic Pain
Intestinal Diseases
Inflammatory Bowel Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Muscular Diseases
Musculoskeletal Diseases