Complex Regional Pain Syndrome (CRPS) and the Gut-bacteria

NCT05473338 | Unknown

• 1 other identifier: CRPS-MB 2021-6735
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate, for the first time, whether gut bacteria composition and function of patients with CRPS differ from those of healthy adults. Samples of stool, urine and blood will be collected from patients with CRPS and from healthy adults. The type and function of bacteria of CRPS patients will be analyzed and compared to those of healthy adults to test if potential differences could explain the mechanism/s involved with the development of CRPS.

Conditions

CRPS

Outcome Measures

Primary Outcomes (2)

• Gut microbiome composition

  Assessment of genomic composition of the gut bacteria by differential abundance analysis will be performed using 16S rRNA (Genome-Quebec)

  1 day

• Presence of stool microbiota-related metabolites affecting host physiology

  Concentration of bile acids and short-chain-fatty-acids through Metabolomics analysis (Metabolon, USA).

  1 day

Secondary Outcomes (4)

• Short-form health-questionnaire (SF12) score

  1 day

• Brief Pain Inventory (BPI) score

  1 day

• Patient Health Questionnaire (PHQ-9) score

  1 day

• Pittsburg Sleep Quality Index (PSQI) scores

  1 day

Study Arms (2)

CRPS (Complex Regional Pain Syndrome)

Participants with CRPS (Complex Regional Pain Syndrome))

Diagnostic Test: Stool and blood samples; Other: Physical examination; Other: Questionnaires

Healthy

Healthy individuals

Diagnostic Test: Stool and blood samples; Other: Questionnaires

Interventions

Stool and blood samples DIAGNOSTIC_TEST

fecal microbiome and metabolomics, as well as metabolites in plasma

CRPS (Complex Regional Pain Syndrome); Healthy

Physical examination OTHER

physical examination performed by a physician to confirm CRPS diagnosis and assess patient's eligibility to participate in the study. The exam will include skin temperature measured using a laser/infrared skin thermometry.

CRPS (Complex Regional Pain Syndrome)

Questionnaires OTHER

Questionnaires measuring pain level, sleep, mood and diet parameters.

CRPS (Complex Regional Pain Syndrome); Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women and men with CRPS and healthy volunteers.

You may qualify if:

• Women and men over the age of 18, diagnosed with CRPS of the upper or lower limb according to the Clinical Budapest Criteria, with a duration of 6 months and over (for the 1st study group).
• Healthy women and men over the age of 18, who share a household with a CRPS patients participating in the study (for the 1st control group).
• Healthy women and men over the age of 18 (for the 2nd control group).
• Be able to read and write in either French, English or Hebrew.

You may not qualify if:

• Any major illness (eg. malignancy, active inflammatory disease, metabolic disease, etc.)
• Pregnancy
• Chronic pain conditions (other than CRPS in the patients group)
• Acute illness of any type in the preceding 1 month
• Use of systemic antibiotics in the preceding 1 month
• Change in any other regularly taken medications in the past 1 month
• Substantial dietary / gastrointestinal alterations in the past 1 month.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Louise and Alan Edwards Foundation: collaborator
• Rambam Health Care Campus: collaborator

Study Sites (1)

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (4)

• Birklein F, Ajit SK, Goebel A, Perez RSGM, Sommer C. Complex regional pain syndrome - phenotypic characteristics and potential biomarkers. Nat Rev Neurol. 2018 May;14(5):272-284. doi: 10.1038/nrneurol.2018.20. Epub 2018 Mar 16.

  PMID: 29545626 BACKGROUND

• Birklein F, O'Neill D, Schlereth T. Complex regional pain syndrome: An optimistic perspective. Neurology. 2015 Jan 6;84(1):89-96. doi: 10.1212/WNL.0000000000001095. Epub 2014 Dec 3.

  PMID: 25471395 BACKGROUND

• Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med. 2007 May-Jun;8(4):326-31. doi: 10.1111/j.1526-4637.2006.00169.x.

  PMID: 17610454 BACKGROUND

• Minerbi A, Gonzalez E, Brereton NJB, Anjarkouchian A, Dewar K, Fitzcharles MA, Chevalier S, Shir Y. Altered microbiome composition in individuals with fibromyalgia. Pain. 2019 Nov;160(11):2589-2602. doi: 10.1097/j.pain.0000000000001640.

  PMID: 31219947 BACKGROUND

MeSH Terms

Interventions

Defecation; Blood Specimen Collection; Restraint, Physical; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Behavior Control; Therapeutics; Immobilization; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yoram Shir, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, the Alan Edwards Pain Management Unit

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: July 25, 2022
• Study Start: April 14, 2022
• Primary Completion: October 14, 2022
• Study Completion: June 30, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)