Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation
CompletedNCT07074275
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Predictive Relationship Between Chronic Fibromyalgia Pain and Lifestyle Factors and Role of Inflammation: A Pilot Trial
- Conditions
- Sponsor
- Bournemouth University
- Collaborators
- Vrije Universiteit Brussel
- Start date
- 2025-05-29
- Primary completion
- 2025-08-23
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Female * Aged between 18-65 years old * Clinically diagnosed with fibromyalgia * Experiencing chronic musculoskeletal pain for at least 3 months, occurring on a minimum of 3 days per week * Able to understand study procedures and provide informed consent * Willing to comply with study requirements (e.g., wear activity tracker, complete food logs, questionnaires, and attend assessment sessions) Exclusion Criteria: * Diagnosis of any active cancer or history of cancer within the past 5 years * Use of immunosuppressive medications (e.g., corticosteroids, chemotherapy, biologics) * Presence of systemic inflammatory or metabolic conditions, such as: Type 1 or Type 2 Diabetes, Rheumatoid arthritis, Lupus or other autoimmune disorders. * Current pregnancy or breastfeeding * Acute infection or illness at the time of data collection * Inability or unwillingness to comply with study procedures (e.g., technology use, blood draw)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07074275