Clinical Trial

Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation

Study acronym: BUFS
Completed
View on ClinicalTrials.gov →
Summary
The goal of this observational study is to understand how lifestyle factors (such as diet, physical activity, sleep, stress, smoking, and alcohol intake) predict changes in pain sensitivity and modulation in adults aged 18-65 with chronic fibromyalgia pain. The main questions it aims to answer are: What is the predictive relationship between lifestyle factors and pain sensitivity/modulation? What is the mediating role of inflammation in the relationship between lifestyle factors and pain? Researchers will explore how various lifestyle factors collectively and individually relate to pain responses and whether inflammatory markers (IL-6, TNF-α, IL-10) mediate these associations. Participants will: Wear a Fitbit for two weeks to measure physical activity and sleep Use the Nutritics app to log food intake Complete an online questionnaire on pain, sleep quality, stress, and quality of life Undergo pain sensitivity testing using a digital algometer and pressure cuff Have body weight, height, and BMI measured Provide a blood sample for analysis of inflammatory markers via ELISA
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-10; most recent amendment 2026-04-18.
Status change: Active, Not Recruiting → Completed 2026-04-18
Status change: Recruiting → Active, Not Recruiting 2025-08-26
Trial Details
NCT Number NCT07074275
Lead Sponsor Bournemouth University
Collaborators: Vrije Universiteit Brussel
Conditions Fibromyalgia (FM)
Enrollment 20 participants
Start Date 2025-05-29
Primary Completion 2025-08-23 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-21