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| Name | Class |
|---|---|
| Louise and Alan Edwards Foundation | UNKNOWN |
| Rambam Health Care Campus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRPS (Complex Regional Pain Syndrome) | Participants with CRPS (Complex Regional Pain Syndrome)) |
| |
| Healthy | Healthy individuals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool and blood samples | Diagnostic Test | fecal microbiome and metabolomics, as well as metabolites in plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Short-form health-questionnaire (SF12) score | A 12-item measure of health-related quality of life, validated in a variety of population groups | 1 day |
| Brief Pain Inventory (BPI) score | A 12-item questionnaire evaluating function level and disability among pain patients |
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Inclusion criteria:
Exclusion criteria:
The inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition.
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Adult women and men with CRPS and healthy volunteers.
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Shir, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alan Edwards Pain Management Unit - Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29545626 | Background | 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. | |
| 25471395 | 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. |
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| ID | Term |
|---|---|
| D003672 | Defecation |
| D001800 | Blood Specimen Collection |
| D012149 | Restraint, Physical |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
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| 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. |
|
| Questionnaires | Other | Questionnaires measuring pain level, sleep, mood and diet parameters. |
|
| 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 | 1 day |
| Pittsburg Sleep Quality Index (PSQI) scores | A standardized self-administered questionnaire for the assessment of subjective sleep quality | 1 day |
| 17610454 | 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. |
| 31219947 | 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. |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |