Fibromyalgia (FM)BUFSNCT07074275
Chronic Fibromyalgia Pain, Lifestyle Factors, and Inflammation
An observational study of Fibromyalgia (FM), run by Bournemouth University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia (FM)
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 May 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Performance Lab, Talbot Campus, Bournemouth University
Bournemouth, BH125BB
About this study
Official title: 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?
Read more
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
Read the 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)
- 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
- Medical subject headings
- Fibromyalgia, Inflammation, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
Pressure pain threshold will be measured with a handheld pressure algometer.
Measured: 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.
Measured: 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.
Measured: At the second visit (Day 2)
Pain Intensity
Pain intensity will be measured brief pain inventory.
Measured: At the first visit (Day 1)
Total sleep duration
Total sleep hours will be measured with Fitbit Charge 6 wearable device.
Measured: between first and second visit.
Sleep Quality
Sleep quality will be measured with Pittsburg Sleep Quality Index.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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.'
Measured: At the first visit (Day 1)
Secondary outcomes (6)
Inflammatory Biomarkers
Serum concentrations of IL-6, TNF-α, and IL-10 as measured by ELISA.
Measured: 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.
Measured: 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.
Measured: At the first visit (Day 1)
Body weight
Body weight will be measured using a Seca weight scale and recorded in kilograms (kg).
Measured: At the second visit (day 2)
Body height
Body height will be measured using a Seca length meter and recorded in centimeters (cm).
Measured: At the second visit (Day 2)
Body mass index
weight and height will be combined to report BMI in kg/m^2
Measured: at the second visit (day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start29 May 2025
- Primary completion23 Aug 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Omer Elma, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074275
- Sponsor's protocol ID
- 61104
- Acronym
- BUFS
- Status last verified
- Apr 2026
- First submitted
- 30 Jun 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Relationship Between Chronic Fibromyalgia Pain and Lifestyle Factors and Role of Inflammation: A Pilot Trial
- ClinicalTrials.gov ID
- NCT07074275
- Acronym / sponsor ID
- BUFS / 61104
- Conditions
- Fibromyalgia (FM)
- Keywords
- Fibromyalgia, Chronic musculoskeletal pain, lifestyle, inflammation, Fitbit, Quantitative sensory testing, Physical activity, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 29 May 2025 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pressure Pain Threshold
Time frame: At the second visit (Day 2)
Pressure pain threshold will be measured with a handheld pressure algometer.
Temporal summation
Time frame: 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
Time frame: 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
Time frame: At the first visit (Day 1)
Pain intensity will be measured brief pain inventory.
Total sleep duration
Time frame: between first and second visit.
Total sleep hours will be measured with Fitbit Charge 6 wearable device.
Sleep Quality
Time frame: At the first visit (Day 1)
Sleep quality will be measured with Pittsburg Sleep Quality Index.
Dietary intake
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.'
6 secondary outcomes
Inflammatory Biomarkers
Time frame: Baseline assessment
Central sensitization inventory
Time frame: At the first visit
Fibromyalgia impact questionnaire
Time frame: At the first visit (Day 1)
Body weight
Time frame: At the second visit (day 2)
Body height
Time frame: At the second visit (Day 2)
Body mass index
Time frame: at the second visit (day 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia (FM), run by Bournemouth University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (time frame: At the second visit (Day 2)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.