Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation

Recruiting

• Conditions: Fibromyalgia (FM)

• Registration Number: NCT07074275
• Lead Sponsor: Bournemouth University

Brief 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.

Study Timeline

• Study Start: 2025-05-29
• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure Pain Threshold	At the second visit (Day 2)	Pressure pain threshold will be measured with a handheld pressure algometer.
Temporal summation	at the second visit (Day 2)	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.
Conditioned pain modulation	At the second visit (Day 2)	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.
Pain Intensity	At the first visit (Day 1)	Pain intensity will be measured brief pain inventory.
Total sleep duration	between first and second visit.	Total sleep hours will be measured with Fitbit Charge 6 wearable device.
Sleep Quality	At the first visit (Day 1)	Sleep quality will be measured with Pittsburg Sleep Quality Index.
Dietary intake	between first and second visit	Dietary intake will be assessed with 3 day dietary intake dairy. Nutrient intakes will be analysed with use of nutritics software.
Total number of steps	between first and second visit	Physical activity level will be assessed using data from the Fitbit Charge 6 wearable device, specifically by recording the total number of steps.
Percieved Stress	At the first visit (day 1)	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.
Alcohol intake frequency	At the first visit (Day 1)	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'.
Smoking status	At the first visit (Day 1)	Smoking status will be assessed by asking participants to select one of three pre-defined options: 'Current smoker,' 'Never smoked,' or 'Previous smoker.'

Secondary Outcome Measures

Name	Time	Method
Inflammatory Biomarkers	Baseline assessment	Serum concentrations of IL-6, TNF-α, and IL-10 as measured by ELISA.
Central sensitization inventory	At the first visit	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.
Fibromyalgia impact questionnaire	At the first visit (Day 1)	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.
Body weight	At the second visit (day 2)	Body weight will be measured using a Seca weight scale and recorded in kilograms (kg).
Body height	At the second visit (Day 2)	Body height will be measured using a Seca length meter and recorded in centimeters (cm).
Body mass index	at the second visit (day 2)	weight and height will be combined to report BMI in kg/m\^2

Trial Locations

Locations (1)

Human Performance Lab, Talbot Campus, Bournemouth University; 🇬🇧 Bournemouth, United Kingdom