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

Active, not recruiting

• Conditions: CRPS
• Interventions: Diagnostic Test: Stool and blood samples; Other: Physical examination; Other: Questionnaires

• Registration Number: NCT05473338
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-12
• Study Start: 2022-04-14
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Status Verified: 2022-10
• Primary Completion: 2022-10-14
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRPS (Complex Regional Pain Syndrome)	Stool and blood samples	Participants with CRPS (Complex Regional Pain Syndrome))
CRPS (Complex Regional Pain Syndrome)	Physical examination	Participants with CRPS (Complex Regional Pain Syndrome))
Healthy	Questionnaires	Healthy individuals
Healthy	Stool and blood samples	Healthy individuals
CRPS (Complex Regional Pain Syndrome)	Questionnaires	Participants with CRPS (Complex Regional Pain Syndrome))

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Alan Edwards Pain Management Unit - Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada