CRPS
Conditions
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.
Interventions
DIAGNOSTIC_TESTStool and blood samples
fecal microbiome and metabolomics, as well as metabolites in plasma
OTHERPhysical examination
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.
OTHERQuestionnaires
Questionnaires measuring pain level, sleep, mood and diet parameters.
Sponsors
Louise and Alan Edwards Foundation
Rambam Health Care Campus
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition | 1 day | Assessment of genomic composition of the gut bacteria by differential abundance analysis will be performed using 16S rRNA (Genome-Quebec) |
| Presence of stool microbiota-related metabolites affecting host physiology | 1 day | Concentration of bile acids and short-chain-fatty-acids through Metabolomics analysis (Metabolon, USA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-form health-questionnaire (SF12) score | 1 day | A 12-item measure of health-related quality of life, validated in a variety of population groups |
| Brief Pain Inventory (BPI) score | 1 day | A 12-item questionnaire evaluating function level and disability among pain patients |
| Patient Health Questionnaire (PHQ-9) score | 1 day | A 9 item inventory rated on a 4 point Likert-type scale used for screening for depression and anxiety |
| Pittsburg Sleep Quality Index (PSQI) scores | 1 day | A standardized self-administered questionnaire for the assessment of subjective sleep quality |
Countries
Canada
Outcome results
None listed