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

McGill University Health Centre/Research Institute of the McGill University Health Centre250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

CRPS

Interventions

Stool and blood samplesDIAGNOSTIC_TEST

fecal microbiome and metabolomics, as well as metabolites in plasma

Physical examinationOTHER

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.

QuestionnairesOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. 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). 2. 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). 3. Healthy women and men over the age of 18 (for the 2nd control group). 4. Be able to read and write in either French, English or Hebrew. Exclusion criteria: 1. Any major illness (eg. malignancy, active inflammatory disease, metabolic disease, etc.) 2. Pregnancy 3. Chronic pain conditions (other than CRPS in the patients group) 4. Acute illness of any type in the preceding 1 month 5. Use of systemic antibiotics in the preceding 1 month 6. Change in any other regularly taken medications in the past 1 month 7. Substantial dietary / gastrointestinal alterations in the past 1 month. The inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition.

Locations (1)

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Gut microbiome composition

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

Time frame: 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).

Time frame: 1 day

Secondary Outcomes

Short-form health-questionnaire (SF12) score

A 12-item measure of health-related quality of life, validated in a variety of population groups

Time frame: 1 day

Brief Pain Inventory (BPI) score

A 12-item questionnaire evaluating function level and disability among pain patients

Time frame: 1 day

Patient Health Questionnaire (PHQ-9) score

A 9 item inventory rated on a 4 point Likert-type scale used for screening for depression and anxiety

Time frame: 1 day

Pittsburg Sleep Quality Index (PSQI) scores

A standardized self-administered questionnaire for the assessment of subjective sleep quality

Time frame: 1 day

Data from ClinicalTrials.gov

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