Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation

NCT07074275 | Completed

• 1 other identifier: 61104
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia (FM)

Keywords

Fibromyalgia; Chronic musculoskeletal pain; lifestyle; inflammation; Fitbit; Quantitative sensory testing; Physical activity; sleep; Diet; temporal summation; conditioned pain modulation; IL-6; IL-10; TNF-alpha

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (6)

• Inflammatory Biomarkers

  Baseline assessment

• Central sensitization inventory

  At the first visit

• Fibromyalgia impact questionnaire

  At the first visit (Day 1)

• Body weight

  At the second visit (day 2)

• Body height

  At the second visit (Day 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bournemouth University: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Human Performance Lab, Talbot Campus, Bournemouth University

Bournemouth, BH125BB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum inflammatory biomarkers

MeSH Terms

Conditions

Fibromyalgia; Inflammation; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 20, 2025
• Study Start: May 29, 2025
• Primary Completion: August 23, 2025
• Study Completion: January 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: starting from the end of the completion of the study
• Access Criteria: Upon reasonable request, by contacting to principal investigator.

Locations

GB (1)