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The objective of this prospective, observational study is to determine the association between the composition of the gut microbiota and the severity and persistence of Complex Regional Pain Syndrome symptoms (Study A). The objective of Study B, a longitudinal study of microbiota biomarkers of patients with newly diagnosed CRPS is to determine if the researchers can predict which patients are more likely to recover compared to those who do not. A secondary objective of both studies is to examine cognitive flexibility in relation to outcomes (study A and B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study A: Chronic >1 year | |||
| Study A: Acute <1 year | |||
| Study A: Household Control | |||
| Study B: Newly Diagnosed <6 months | |||
| Study B: Household Controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to CRPS severity score | Study A | 1 visit - up to one month |
| Number of participants with taxonomic and metabolomic differences of the gut microbiome in relation to recovery from CRPS | Study B | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score results of the Stroop Color Word Test in relation to CRPS recovery | Study B | 12 months |
| Logistic regression analysis for testing the association of CRPS severity score to weight in kilograms and height in meters aggregated to BMI (kilograms/meters squared) |
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Study A: Cross-sectional study
Inclusion criteria, cases:
Inclusion criteria, controls
Study B: Longitudinal Study
Inclusion criteria, cases:
Inclusion criteria, controls
Study A and B: Exclusion criteria, cases and controls:
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Pain Management Center at Washington University/Barnes-Jewish Hospital medical campus
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara Crock, MD PhD | Contact | 314-546-3882 | crockl@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lara Crock, MD PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20493633 | Background | Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20. | |
| 29392238 |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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Taxonomic and metabolomic biomarkers
Study B |
| 12 months |
| Logistic regression analysis for testing the association of CRPS severity score to use of opioid analgesics | Study B | 12 months |
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| 39670171 | Derived | Crock LW, Rodgers R, Huck NA, Schriefer LA, Lawrence D, Wang L, Muwanga GPB, Tawfik VL, Baldridge MT. Chronic pain and complex regional pain syndrome are associated with alterations to the intestinal microbiota in both humans and mice. An observational cross-sectional study. Neurobiol Pain. 2024 Nov 25;16:100173. doi: 10.1016/j.ynpai.2024.100173. eCollection 2024 Jul-Dec. |