Chronic Widespread Pain
Conditions
Brief summary
We aim to identify the gut microbiome composition in adults with CWP. We will collect the stool sample of 120 healthy individuals and 120 Chronic Widespread Pain patients. We hypothesize that the intestinal microbiota is altered in CWP compared to healthy subjects without CWP.
Detailed description
We aim to identify the variations in gut microbiota composition in Hong Kong adults with CWP. We hypothesize that the intestinal microbiota is altered in CWP compared to healthy control. The design of the study is a pilot case-control study with adults with CWP (n=120) and healthy adults without any chronic pain (n=120). Participants will be recruited in 8 general-outpatient clinics in the New Territories East region of Hong Kong.
Interventions
None listed
Sponsors
Chinese University of Hong Kong
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants with Chronic Widespread pain Participants will be asked, In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?, as a screening question for CWP. To meet the criteria for CWP, subjects have to report musculoskeletal pain in at least 4 of 5 body regions and in at least 3 or more body quadrants (as defined by upper-lower/left-right side of the body) and axial skeleton (neck, back, chest, and abdomen), with pain duration of more than 3 months. A Widespread Pain Index (WPI) will be generated based on the number of pain sites. Subgroup of patients with fibromyalgia will be identified according to The American College of Rheumatology 2016 when subjects WPI of ≥ 7 and a symptom severity scale (SSS) score of ≥ 5 or a WPI between 4 and 6 and an SSS score of ≥ 9. 2. Healthy Participants Healthy participants will be those without chronic pain and depression. A screening question 'In the past 3 months, have you had pain in your muscles, bones and joints lasting at least 1 week?' will be asked to determine whether participant has chronic pain. Depression status will be determined by the questionnaire Patient Health Questionnaire-9
Exclusion criteria
* Participants with major chronic illnesses, such as malignancy, active inflammatory diseases, autoimmune diseases and metabolic diseases such as diabetes mellitus and thyroid diseases etc.; use of antibiotics, probiotics or prebiotics in the preceding 2 months, any acute illness in the preceding month, change in regularly taken medication in the preceding month, and substantial dietary alterations in the preceding month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition | week 1 | The gut microbiome composition of participants with CWP, as compared with healthy participants |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive status | At baseline, study week 0 | The depressive status of participants will be assessed by the Patient Health Questionnaire (PHQ-9), a 9-item self-reported measures to diagnose and assess the severity of depression. |
| Dietary intake | At study week 1 | Dietary intake will be assessed by the Hong Kong Diet Score (HKDS), a 9-item diet screener, based on Mediterranean Diet Score (MDS) cutoff values and Hong Kong Chinese food consumption reported by the government. |
| Bowel habit | At study week 1 | Bowel habit will be assessed by the Bristol Stool Scale (BSS), a validated measure of intestinal transit that categorizes stool into 7 types from type 1 (hard lumps) to type 7 (watery diarrhea) |
| Physical activity level | At study week 1 | Physical activity will be assessed by the Chinese version of International Physical Activity Questionnaire (IPAQ) short form. |
| Sociodemographic data | At baseline, study week 0 | Sociodemographic information such as age and sex, comorbid diseases, lifestyle habits (smoking and drinking status) |
| BMI | At baseline, study week 0 | — |
| Use of Chronic medications | At baseline, study week 0 | The use of chronic medications will be enquired from participants and further confirmed with hospital electronic system. |
Countries
Hong Kong
Contacts
Primary ContactCheryl Fung
Outcome results
None listed