FibromyalgiaSTRAINNCT06892977
Mapping Stress and Pain Interactions (G072323N)
An observational study of Fibromyalgia and Chronic Low Back Pain, run by University Ghent at 1 site in Belgium.
Trial summary
The over-arching goal of this observational (case-control, with a cross-sectional and longitudinal arm) study is to comprehensively map stress system (dys)function (including reactivity and recovery) in people with primary musculoskeletal (MSK) pain and a pain-free control group. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Low Back Pain, Subacute Low Back Pain
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Feb 2025to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study population is a community sample.
Who may be able to join
- Participants aged 18 to 55 years with a BMI between 17 and 35 kg/m², who are proficient in the Dutch language and do not meet the exclusion criteria listed below
Who cannot join
- Body weight >150 kg (maximum weight for the MRI scanner).
- Postmenopausal individuals.
- Use of hormone replacement therapy.
- Current or history of severe psychiatric, neurological (related to the brain, spinal cord, or nerves), endocrine (related to the hormonal system), or cardiovascular (related to the heart and blood vessels) conditions (e.g., cancer, cardiovascular disease, epilepsy, diabetes, etc.).
- History of spinal surgery, spinal trauma, severe spinal deformities, or neurogenic back pain.
- Having a severe communicative or cognitive disorder.
Show all 11Show fewer
- Use of medication that is not stable for at least 1 month prior to the test session.
- Regular drug use (≥1 time per week).
- Contraindications for MRI (such as claustrophobia, implanted electronic devices like a pacemaker, metal splinters in the body, etc.).
- Currently pregnant or have been pregnant in the past year.
- Breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Ghent University, Department of Rehabilitation Sciences
Ghent, 9000
About this study
Official title: STRAIN (STRessinpAIN): A Comprehensive Mapping of Stress System Interactions With Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain
The over-arching goal of this observational (case-control, with a cross-sectional and longitudinal arm) study is to comprehensively map stress system (dys)function (including reactivity and recovery) in people with primary musculoskeletal (MSK) pain and a pain-free control group.
- The primary objective is to characterize stress systems functioning and their relation to pain in individuals with subacute versus chronic, and localized versus widespread MSK pain, and compare to pain-free controls.
- The secondary objective is to define the contribution of stress system functioning to trajectories of MSK pain, including pain chronification or recovery from pain.
Read more
Researchers will compare primary musculoskeletal pain groups with pain-free controls. Participants will:
- Fill out online questionnaires.
- Provide a sample of hair and saliva to assess chronic and acute stress hormone levels, respectively. Saliva samples will be collected both in the lab and at home.
- Be subject to psychophysiological monitoring.
- Partake in quantitative sensory testing measuring pain thresholds, tolerances and pain modulation of pressure and heat. These tests will be repeated twice: before and after an acute-stress induction task.
- Partake in a series of stress-inducting tasks.
- Be subject to MRI-scans of the brain, including structural and functional MR acquisitions (e.g., during rest and during pain inductions).
Participants will be invited for a second session of the same assessments six months later to observe possible connection between pain trajectory and stress system (dys)function.
- Conditions
- Fibromyalgia, Chronic Low Back Pain, Subacute Low Back Pain
- Keywords
- Stress system, Musculoskeletal pain, Pain chronification, Pain processing, Neural correlates of pain, Stress reactivity, Stress recovery, Autonomic nervous system (ANS), Hypothalamus-pituitary-adrenal axis (HPA axis), Chronic widespread pain, Chronic localized pain, Oxytocin, Low back pain, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Musculoskeletal Pain, Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| fibromyalgia | Proof of a primary fibromyalgia diagnosis with chronic widespread pain by a specialist-doctor, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index. | |
| chronic low back pain | Chronic primary (non-specific) low back pain with primary onset ≥6 months ago, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index. | |
| subacute low back pain | Non-specific low back pain with primary onset <3 months ago, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index. | |
| pain-free/healthy control | Exclusion criteria include current pain (>0 on a Visual Analogue Scale); a pain condition in the last 6 months for which treatment was sought; history of a chronic pain syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory testing - pressure pain threshold
Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg.
Measured: At baseline
Quantitative sensory testing - heat pain suprathreshold
Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C.
Measured: At baseline
Quantitative sensory testing - conditioned pain modulation
Determination of conditioned pain modulation with a parallel protocol, with test stimulus and conditioning stimulus equal to the heat pain suprathreshold temperature. Pain will be scored on a verbal rating scale 0-100.
Measured: At baseline
Quantitative sensory testing - temporal summation of pain
Determination of temporal summation of pain with a tonic protocol. Heat stimuli will be applied for two minutes, with the temperature equal to the heat pain suprathreshold. Pain will be scored on a verbal rating scale 0-100.
Measured: At baseline
Task-based functional MRI - experimental pain induction task
This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation.
Measured: At baseline
Salivary cortisol concentration
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse cortisol concentration; providing information about the hypothalamus-pituitary-adrenal-axis functioning.
Measured: At baseline
Salivary alpha-amylase concentration
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse alpha-amylase concentrations; which gives information about the autonomic nervous system functioning.
Measured: At baseline
Salivary oxytocin concentration
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse oxytocin concentrations; providing information about the oxytocinergic system.
Measured: At baseline
Heart rate
Heart rate, the number of times the heart beat within a certain period, will be measured continuously using ECG (electrocardiogram), providing information on the autonomic nervous system.
Measured: At baseline
Heart rate variability
Heart rate variability (HRV), the fluctuations in time between heart beats, will be measured continuously using ECG. Both time domain and frequency domain of HRV will be examined; providing information on the autonomic nervous system.
Measured: At baseline
Skin conductance
Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system.
Measured: At baseline
Skin temperature
Skin temperature, the measurement of the temperature at the skin's surface will be measured continuously; providing information on the autonomic nervous system.
Measured: At baseline
Respiration rate
Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system.
Measured: At baseline
Blood pressure
Blood pressure, the force exerted by circulating blood on the walls of blood vessels, will be measured using non-continuously; providing information on the autonomic nervous system.
Measured: At baseline
Secondary outcomes (33)
Visual Analogue Scale - Self-reported
Assessment of momentary pain, unpleasantness and stress on a VAS scale ranging from 0-100
Measured: At baseline and at the 6-month follow-up
Pain Disability Index - Self-reported
Assessment of pain-related interference in daily activities, recorded on a 0-70 scale
Measured: At baseline and at the 6-month follow-up
Pain Catastrophizing Scale - Self-reported
Measurement of catastrophic thinking related to pain, recorded on a scale of 0-52.
Measured: At baseline and at the 6-month follow-up
Pain Vigilance and Awareness Questionnaire - Self-reported
Assessment of attention and awareness to pain, recorded on a 0-80 scale.
Measured: At baseline and at the 6-month follow-up
General Perceived Recovery - Self-reported
11-point scale to rate perceived recovery from - 5 (vastly worse), through 0 (no change) to + 5 (greatly improved), to assess recovery or persistence of low back pain
Measured: At baseline and at the 6-month follow-up
Pain Anxiety Symptoms Scale - Self-reported
Assessment of fear and anxiety associated with pain, recorded on a 0-100 scale.
Measured: At baseline and at the 6-month follow-up
Positive and Negative Affect Schedule - Self-reported
Measurement of positive and negative affect levels. Total scores for positive and negative affect range for 10-50 separately.
Measured: At baseline and at the 6-month follow-up
Brief Resilience Scale - Self-reported
Measurement of the ability to recover from stress, recorded on a 5-point Likert scale. This questionnaire contains 6 items.
Measured: At baseline and at the 6-month follow-up
Intolerance of Uncertainty Scale - Self-reported
Assessment of intolerance to uncertainty, recorded on a scale of 1-5 for each item, with 12 items in total.
Measured: At baseline and at the 6-month follow-up
Stress Mindset Measure - Self-reported
Evaluation of beliefs about the nature of stress (enhancing vs. debilitating), recorded on a scale of 0-4 for each item, with 8 items in total.
Measured: At baseline and at the 6-month follow-up
Perceived Stress Scale - Self-reported
Measurement of perceived stress over the past month, recorded on a scale of 0-40.
Measured: At baseline and at the 6-month follow-up
Hospital Anxiety and Depression Scale - Self-reported
Assessment of anxiety and depression symptoms, recorded on a scale of 0-21 for anxiety and depression subscales separately.
Measured: At baseline and at the 6-month follow-up
Childhood Trauma Questionnaire - Self-reported
Measurement of childhood trauma experiences. A shortened version will be used with scores ranging from 0-25. Emotional abuse, physical abuse, and neglect components will be assessed.
Measured: At baseline and at the 6-month follow-up
Pittsburgh Sleep Quality Index - Self-reported
Measurement of sleep quality over the past month. A shortened version will be used with scores ranging from 0-12. Component 1-4 will be scored.
Measured: At baseline and at the 6-month follow-up
Gender and Pain Questionnaire - Self-reported
Collection of scales of measures for gender conceptualization, gender identity and gendered pain beliefs
Measured: At baseline and at the 6-month follow-up
T1 weighted anatomical MRI data
Through Magnetization Prepared-Rapid Gradient Echo, macro-structural properties of grey matter, such as surface area, cortical thickness or volume will be characterized.
Measured: At baseline and at the 6-month follow-up
Resting state functional MRI
This type of MRI-scan will allow us to evaluate functional connectivity of the brain.
Measured: At baseline and at the 6-month follow-up
Diffusion weighted MRI data
Diffusion weighted MR imaging will provide insights in microstructural properties of white matter (i.e., factional anisotropy, mean diffusivity, etc.).
Measured: At baseline and at the 6-month follow-up
Pseudo-Continuous Arterial Spin Labeling - MRI
This type of MRI will provide information on brain blood perfusion parameters.
Measured: At baseline and at the 6-month follow-up
Quantitative sensory testing - pressure pain threshold (at follow-up)
Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg.
Measured: At the 6-month follow-up
Quantitative sensory testing - heat pain suprathreshold (at follow-up)
Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C.
Measured: At the 6-month follow-up
Quantitative sensory testing - conditioned pain modulation (at follow-up)
Determination of conditioned pain modulation with a parallel protocol, with test stimulus and conditioning stimulus equal to the heat pain suprathreshold temperature. Pain will be scored on a verbal rating scale 0-100.
Measured: At the 6-month follow-up
Quantitative sensory testing - temporal summation of pain (at follow-up)
Determination of temporal summation of pain with a tonic protocol. Heat stimuli will be applied for two minutes, with the temperature equal to the heat pain suprathreshold. Pain will be scored on a verbal rating scale 0-100.
Measured: At the 6-month follow-up
Task-based functional MRI - experimental pain induction task (at follow-up)
This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation.
Measured: At the 6-month follow-up
Salivary cortisol concentration (at follow-up)
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse cortisol concentrations; providing information about the hypothalamus-pituitary-adrenal-axis functioning.
Measured: At the 6-month follow-up
Salivary alpha-amylase concentration (at follow-up)
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse alpha-amylase concentrations; providing information about the autonomic nervous system functioning.
Measured: At the 6-month follow-up
Salivary oxytocin concentration (at follow-up)
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse oxytocin concentrations; providing information on the oxytocinergic system.
Measured: At the 6-month follow-up
Heart rate (at follow-up)
Heart rate, the number of times the heart beat within a certain period, will be measured with ECG continuously, and is part of the autonomic nervous system.
Measured: At the 6-month follow-up
Heart rate variability (at follow-up)
Heart rate variability, the fluctuations in time between heart beats, will be measured with ECG continuously. Both time domains and frequency domains of HRV will be examined. This parameter is part of the autonomic nervous system.
Measured: At the 6-month follow-up
Skin conductance (at follow-up)
Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system.
Measured: At the 6-month follow-up
Skin temperature (at follow-up)
Skin temperature, the measurement of the temperature at the skin's surface will be measured continuously; providing information on the autonomic nervous system.
Measured: At the 6-month follow-up
Respiration rate (at follow-up)
Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system.
Measured: At the 6-month follow-up
Blood pressure (at follow-up)
Blood pressure, the force exerted by circulating blood on the walls of blood vessels, will be measured using non-continuously; providing information on the autonomic nervous system.
Measured: At the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start8 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Tilburg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892977
- Sponsor's protocol ID
- ONZ-2024-0391
- Acronym
- STRAIN
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Ghent University will be the data controller. The collected data can only be shared upon request and after finalization of the predetermined statistical analyses and publication of the results. Identifiable data will not be shared. Data sharing is only permitted if all involved parties agree, and if a Data Sharing Agreement is signed.
Publications
Moerkerke M, Vyverman J, De Baere R, Clement P, Smeets T, Coppieters I, Timmers I, Van Oosterwijck J. A comprehensive mapping of stress system interactions with pain and their contribution to chronification of musculoskeletal pain: Protocol of the STRAIN study. PLoS One. 2025 Jun 24;20(6):e0324089. doi: 10.1371/journal.pone.0324089. eCollection 2025.
PubMed 40554512
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRAIN (STRessinpAIN): A Comprehensive Mapping of Stress System Interactions With Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06892977
- Acronym / sponsor ID
- STRAIN / ONZ-2024-0391
- Conditions
- Fibromyalgia, Chronic Low Back Pain, Subacute Low Back Pain
- Keywords
- Stress system, Musculoskeletal pain, Pain chronification, Pain processing, Neural correlates of pain, Stress reactivity, Stress recovery, Autonomic nervous system (ANS)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Tilburg University
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 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 over-arching goal of this observational (case-control, with a cross-sectional and longitudinal arm) study is to comprehensively map stress system (dys)function (including reactivity and recovery) in people with primary musculoskeletal (MSK) pain and a pain-free control group.
- The primary objective is to characterize stress systems functioning and their relation to pain in individuals with subacute versus chronic, and localized versus widespread MSK pain, and compare to pain-free controls.
- The secondary objective is to define the contribution of stress system functioning to trajectories of MSK pain, including pain chronification or recovery from pain.
Researchers will compare primary musculoskeletal pain groups with pain-free controls. Participants will:
- Fill out online questionnaires.
- Provide a sample of hair and saliva to assess chronic and acute stress hormone levels, respectively. Saliva samples will be collected both in the lab and at home.
- Be subject to psychophysiological monitoring.
- Partake in quantitative sensory testing measuring pain thresholds, tolerances and pain modulation of pressure and heat. These tests will be repeated twice: before and after an acute-stress induction task.
- Partake in a series of stress-inducting tasks.
- Be subject to MRI-scans of the brain, including structural and functional MR acquisitions (e.g., during rest and during pain inductions).
Participants will be invited for a second session of the same assessments six months later to observe possible connection between pain trajectory and stress system (dys)function.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fibromyalgia | – | –Proof of a primary fibromyalgia diagnosis with chronic widespread pain by a specialist-doctor, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index. |
| chronic low back pain | – | –Chronic primary (non-specific) low back pain with primary onset ≥6 months ago, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index. |
| subacute low back pain | – | –Non-specific low back pain with primary onset <3 months ago, with an average pain intensity of ≥2/10 on a Visual Analogue Scale, and with pain-related disability indicated by a score of ≥14/70 on the Pain Disability Index. |
| pain-free/healthy control | – | –Exclusion criteria include current pain (>0 on a Visual Analogue Scale); a pain condition in the last 6 months for which treatment was sought; history of a chronic pain syndrome. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population is a community sample.
Key inclusion criteria (1 listed)
- Participants aged 18 to 55 years with a BMI between 17 and 35 kg/m², who are proficient in the Dutch language and do not meet the exclusion criteria listed below
Key exclusion criteria (11 listed)
- Body weight >150 kg (maximum weight for the MRI scanner).
- Postmenopausal individuals.
- Use of hormone replacement therapy.
- Current or history of severe psychiatric, neurological (related to the brain, spinal cord, or nerves), endocrine (related to the hormonal system), or cardiovascular (related to the heart and blood vessels) conditions (e.g., cancer, cardiovascular disease, epilepsy, diabetes, etc.).
- History of spinal surgery, spinal trauma, severe spinal deformities, or neurogenic back pain.
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
Quantitative sensory testing - pressure pain threshold
Time frame: At baseline
Determination of mechanical pain sensitivity with a digital pressure algometer, recorded in kg.
Quantitative sensory testing - heat pain suprathreshold
Time frame: At baseline
Determination of the mean of heat pain threshold and heat pain tolerance with TSA-2, recorded in °C.
Quantitative sensory testing - conditioned pain modulation
Time frame: At baseline
Determination of conditioned pain modulation with a parallel protocol, with test stimulus and conditioning stimulus equal to the heat pain suprathreshold temperature. Pain will be scored on a verbal rating scale 0-100.
Quantitative sensory testing - temporal summation of pain
Time frame: At baseline
Determination of temporal summation of pain with a tonic protocol. Heat stimuli will be applied for two minutes, with the temperature equal to the heat pain suprathreshold. Pain will be scored on a verbal rating scale 0-100.
Task-based functional MRI - experimental pain induction task
Time frame: At baseline
This type of functional MRI-scanning will allow to capture acute brain responses to (painful) heat stimuli and processes of pain modulation.
Salivary cortisol concentration
Time frame: At baseline
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse cortisol concentration; providing information about the hypothalamus-pituitary-adrenal-axis functioning.
Salivary alpha-amylase concentration
Time frame: At baseline
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse alpha-amylase concentrations; which gives information about the autonomic nervous system functioning.
Salivary oxytocin concentration
Time frame: At baseline
Saliva samples will be taken, with a swab under the tongue for 2 minutes to analyse oxytocin concentrations; providing information about the oxytocinergic system.
Heart rate
Time frame: At baseline
Heart rate, the number of times the heart beat within a certain period, will be measured continuously using ECG (electrocardiogram), providing information on the autonomic nervous system.
Heart rate variability
Time frame: At baseline
Heart rate variability (HRV), the fluctuations in time between heart beats, will be measured continuously using ECG. Both time domain and frequency domain of HRV will be examined; providing information on the autonomic nervous system.
Skin conductance
Time frame: At baseline
Skin conductance reflects sweat gland activity and will be measured continuously; providing information on the autonomic nervous system.
Skin temperature
Time frame: At baseline
Skin temperature, the measurement of the temperature at the skin's surface will be measured continuously; providing information on the autonomic nervous system.
Respiration rate
Time frame: At baseline
Respiration rate, the number of breaths taken per minute will be measured continuously; providing information on the autonomic nervous system.
Blood pressure
Time frame: At baseline
Blood pressure, the force exerted by circulating blood on the walls of blood vessels, will be measured using non-continuously; providing information on the autonomic nervous system.
33 secondary outcomes
Visual Analogue Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Pain Disability Index - Self-reported
Time frame: At baseline and at the 6-month follow-up
Pain Catastrophizing Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Pain Vigilance and Awareness Questionnaire - Self-reported
Time frame: At baseline and at the 6-month follow-up
General Perceived Recovery - Self-reported
Time frame: At baseline and at the 6-month follow-up
Pain Anxiety Symptoms Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Positive and Negative Affect Schedule - Self-reported
Time frame: At baseline and at the 6-month follow-up
Brief Resilience Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Intolerance of Uncertainty Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Stress Mindset Measure - Self-reported
Time frame: At baseline and at the 6-month follow-up
Perceived Stress Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Hospital Anxiety and Depression Scale - Self-reported
Time frame: At baseline and at the 6-month follow-up
Childhood Trauma Questionnaire - Self-reported
Time frame: At baseline and at the 6-month follow-up
Pittsburgh Sleep Quality Index - Self-reported
Time frame: At baseline and at the 6-month follow-up
Gender and Pain Questionnaire - Self-reported
Time frame: At baseline and at the 6-month follow-up
T1 weighted anatomical MRI data
Time frame: At baseline and at the 6-month follow-up
Resting state functional MRI
Time frame: At baseline and at the 6-month follow-up
Diffusion weighted MRI data
Time frame: At baseline and at the 6-month follow-up
Pseudo-Continuous Arterial Spin Labeling - MRI
Time frame: At baseline and at the 6-month follow-up
Quantitative sensory testing - pressure pain threshold (at follow-up)
Time frame: At the 6-month follow-up
Quantitative sensory testing - heat pain suprathreshold (at follow-up)
Time frame: At the 6-month follow-up
Quantitative sensory testing - conditioned pain modulation (at follow-up)
Time frame: At the 6-month follow-up
Quantitative sensory testing - temporal summation of pain (at follow-up)
Time frame: At the 6-month follow-up
Task-based functional MRI - experimental pain induction task (at follow-up)
Time frame: At the 6-month follow-up
Salivary cortisol concentration (at follow-up)
Time frame: At the 6-month follow-up
Salivary alpha-amylase concentration (at follow-up)
Time frame: At the 6-month follow-up
Salivary oxytocin concentration (at follow-up)
Time frame: At the 6-month follow-up
Heart rate (at follow-up)
Time frame: At the 6-month follow-up
Heart rate variability (at follow-up)
Time frame: At the 6-month follow-up
Skin conductance (at follow-up)
Time frame: At the 6-month follow-up
Skin temperature (at follow-up)
Time frame: At the 6-month follow-up
Respiration rate (at follow-up)
Time frame: At the 6-month follow-up
Blood pressure (at follow-up)
Time frame: At the 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 40554512Moerkerke M, Vyverman J, De Baere R, Clement P, Smeets T, Coppieters I, Timmers I, Van Oosterwijck J. A comprehensive mapping of stress system interactions with pain and their contribution to chronification of musculoskeletal pain: Protocol of the STRAIN study. PLoS One. 2025 Jun 24;20(6):e0324089. doi: 10.1371/journal.pone.0324089. eCollection 2025.
- Individual participant dataSharing planned: Undecided. Ghent University will be the data controller. The collected data can only be shared upon request and after finalization of the predetermined statistical analyses and publication of the results. Identifiable data will not be shared. Data sharing is only permitted if all involved parties agree, and if a Data Sharing Agreement is signed.
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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.
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 and Chronic Low Back Pain, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 21 Sep 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quantitative sensory testing - pressure pain threshold (time frame: At baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06892977, which also lists 1 linked publication.
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 Sep 2026.