NCT07074275

Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation

Predictive Relationship Between Chronic Fibromyalgia Pain and Lifestyle Factors and Role of Inflammation: A Pilot Trial

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Bournemouth University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Chronic fibromyalgia pain is a complex and multifaceted condition that significantly affects quality of life and daily functioning. Despite its high prevalence and burden, effective long-term treatment options remain limited. Emerging research highlights the potential influence of modifiable lifestyle factors, such as diet, physical activity, sleep, stress, smoking, and alcohol intake, on pain outcomes, possibly through inflammatory pathways. This cross-sectional observational study investigates how these lifestyle factors are associated with pain sensitivity and pain modulation mechanisms in adults aged 18 to 65 with a clinical diagnosis of fibromyalgia. It also explores whether systemic inflammation, measured by circulating cytokines (IL-6, TNF-α, and IL-10), mediates these relationships. Participants will be recruited and screened for eligibility based on age, diagnosis, and health status. Once enrolled, participants will engage in a two-week data collection period during which they will wear a wrist-worn activity tracker (Fitbit) to passively monitor physical activity levels and sleep parameters. Dietary intake will be logged using a mobile nutrition tracking app (Nutritics), and participants will complete validated online questionnaires assessing perceived stress, sleep quality, pain characteristics, and health-related quality of life. Following the tracking period, participants will attend a clinic session for physiological assessments. Pain sensitivity and modulation will be evaluated using pressure-based methods including a digital algometer and a pressure cuff, both of which are safe and standardized tools in pain research. Anthropometric data, including height, weight, and body mass index (BMI), will be collected using calibrated devices. Finally, a venous blood sample will be drawn for analysis of inflammatory markers using enzyme-linked immunosorbent assay (ELISA). By examining the interplay between lifestyle factors, inflammatory markers, and pain processing mechanisms, this study aims to generate insights that could inform the development of individualized, non-pharmacological strategies for managing fibromyalgia pain more effectively.

Conditions

• Fibromyalgia (FM)

Timeline

• Start date: 2025-05-29
• Primary completion: 2025-08-23
• Completion: 2025-12-31
• First posted: 2025-07-20
• Last updated: 2025-09-02

Locations

1 site across 1 country: United Kingdom