Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation (BUFS)

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

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 Overview

• Status: Completed
• Conditions: Fibromyalgia (FM)

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Bournemouth, United Kingdom, BH125BB
    • Human Performance Lab, Talbot Campus, Bournemouth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from the general public, primarily individuals residing in the Dorset area, including Bournemouth, Poole, and Christchurch. Recruitment was conducted through public announcements on social media platforms such as Facebook. The study is open to those who are able and willing to travel to Bournemouth University for in-person assessments. Participants are not limited to any specific clinical setting and represent a community-based sample of adult females diagnosed with fibromyalgia.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold	Pressure pain threshold will be measured with a handheld pressure algometer.	At the second visit (Day 2)
Temporal summation	Temporal summation will be assessed using a handheld pressure algometer. Following the determination of the individual's pressure pain threshold (PPT), a series of 10 noxious pressure stimuli. The difference in reported pain intensity between the 1st and 10th stimulus application will be calculated as the primary measure of temporal summation.	at the second visit (Day 2)
Conditioned pain modulation	Conditioned Pain Modulation (CPM) will be assessed using a pressure algometer for the test stimulus and a cuff pressure for the conditioning stimulus. Baseline pressure pain threshold (PPT) will be measured on the dominant trapezius muscle. For the conditioning stimulus, a blood pressure cuff on the non-dominant arm will be inflated and maintained at 200 mmHg, or until the participant reports a pain intensity of 6 out of 10 on a numerical rating scale (NRS), for a duration of 10 minutes. During or immediately following the conditioning stimulus, PPT will be re-measured on the dominant trapezius muscle. The change in PPT from baseline to the conditioning phase will quantify the CPM effect.	At the second visit (Day 2)
Pain Intensity	Pain intensity will be measured brief pain inventory.	At the first visit (Day 1)
Total sleep duration	Total sleep hours will be measured with Fitbit Charge 6 wearable device.	between first and second visit.
Sleep Quality	Sleep quality will be measured with Pittsburg Sleep Quality Index.	At the first visit (Day 1)
Dietary intake	Dietary intake will be assessed with 3 day dietary intake dairy. Nutrient intakes will be analysed with use of nutritics software.	between first and second visit
Total number of steps	Physical activity level will be assessed using data from the Fitbit Charge 6 wearable device, specifically by recording the total number of steps.	between first and second visit
Percieved Stress	Perceived stress will be measured using the Perceived Stress Scale (PSS). Scores on the PSS range from 0 to 40, with higher scores indicating greater perceived stress.	At the first visit (day 1)
Alcohol intake frequency	Alcohol intake frequency will be assessed by asking participants to select one of seven pre-defined options: 'Daily or almost daily,' 'Three or four times a week,' 'Once or twice a week,' 'One to three times a month,' 'Special occasions only,' 'Never,' or 'Previously'.	At the first visit (Day 1)
Smoking status	Smoking status will be assessed by asking participants to select one of three pre-defined options: 'Current smoker,' 'Never smoked,' or 'Previous smoker.'	At the first visit (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Biomarkers	Serum concentrations of IL-6, TNF-α, and IL-10 as measured by ELISA.	Baseline assessment
Central sensitization inventory	Central sensitization will be measured using the Central Sensitization Inventory (CSI). Scores on the CSI range from 0 to 100, with higher scores indicating a greater degree of central sensitization.	At the first visit
Fibromyalgia impact questionnaire	Fibromyalgia impact will be measured using the Fibromyalgia Impact Questionnaire (FIQ). Scores on the FIQ range from 0 to 100, with higher scores indicating a greater impact of fibromyalgia on daily life.	At the first visit (Day 1)
Body weight	Body weight will be measured using a Seca weight scale and recorded in kilograms (kg).	At the second visit (day 2)
Body height	Body height will be measured using a Seca length meter and recorded in centimeters (cm).	At the second visit (Day 2)
Body mass index	weight and height will be combined to report BMI in kg/m^2	at the second visit (day 2)

Collaborators and Investigators

• Sponsor: Bournemouth University
• Collaborators: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Actual): August 23, 2025
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: June 30, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep; Physical activity; Diet; inflammation; Fibromyalgia; IL-6; TNF-alpha; lifestyle; Fitbit; Quantitative sensory testing; conditioned pain modulation; Chronic musculoskeletal pain; IL-10; temporal summation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Fibromyalgia; Inflammation; Motor Activity
• Other Study ID Numbers: 61104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) may be shared with other qualified researchers upon reasonable request, for purposes of secondary analysis or meta-analysis. Data will include raw values for pain sensitivity outcomes, lifestyle measures, and cytokine levels.
• IPD Sharing Time Frame: starting from the end of the completion of the study
• IPD Sharing Access Criteria: Upon reasonable request, by contacting to principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No