An observational study in Chronic Widespread Pain, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Chinese University of Hong Kong · Observational
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.
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.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's planned enrollment of 240 is above the median of 128 across 706 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited in 8 general-outpatient clinics in the New Territories East region of Hong Kong. Healthy participants with matching age and sex will be recruited from the general public.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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 without chronic pain and depression
Participants with Chronic Widespread Pain
Gut microbiome composition
The gut microbiome composition of participants with CWP, as compared with healthy participants
Time frame: week 1
Depressive status
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.
Time frame: At baseline, study week 0
Dietary intake
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.
Time frame: At study week 1
Bowel habit
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)
Time frame: At study week 1
Physical activity level
Physical activity will be assessed by the Chinese version of International Physical Activity Questionnaire (IPAQ) short form.
Time frame: At study week 1
Use of Chronic medications
The use of chronic medications will be enquired from participants and further confirmed with hospital electronic system.
Time frame: At baseline, study week 0
Sociodemographic data
Sociodemographic information such as age and sex, comorbid diseases, lifestyle habits (smoking and drinking status)
Time frame: At baseline, study week 0
BMI
Time frame: At baseline, study week 0
Started May 2023 (actual). Primary completion is estimated for May 2025, 24 months after the start.
Of 325 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 24 months is close to that.
Counting every sponsor, half of 350 studies reached it within 25 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →