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Mapping Stress and Pain Interactions (G072323N)

A legfontosabb adatok

Ki végzi
University Ghent
Hol
Belgium1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Csak meghívásos
Résztvevők
140 fő, tervezett
Kezdés
2025. febr. 8.
Várható befejezés
2026. dec.
A vizsgálat típusa
Megfigyeléses, 4 csoport
A regiszteradat frissítve
2026. szeptember 21.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with fibromyalgia, chronic low back pain or recent (subacute) low back pain, and pain-free people as a comparison group. It studies how the body's stress systems relate to pain.

Életkor
18 to 55 years
Nem
All sexes
A betegség stádiuma
Fibromyalgia with widespread long-lasting pain confirmed by a specialist doctor, or non-specific low back pain that started 6 months ago or more, or less than 3 months ago. People with pain need an average pain score of at least 2/10 and a disability score of at least 14/70. Pain-free people can join as a comparison group. They must have no current pain and no long-lasting pain condition in the past. They must not have sought treatment for pain in the last 6 months. All need a BMI between 17 and 35 kg/m² and must speak Dutch well.
Korábbi kezelés
Any medicine must have been stable for at least 1 month before testing. No hormone replacement therapy. No past spinal surgery.

A részvétel fő kizáró okai

  • Body weight >150 kg (331 lb), or anything that rules out MRI, like a pacemaker, metal in the body or fear of small spaces
  • Being past menopause, pregnant now or in the past year, or breastfeeding
  • Severe mental, brain or nerve, hormonal or heart and blood vessel conditions, now or in the past
  • Past spinal surgery or injury, severe spine deformity, or back pain caused by nerve problems
  • Regular drug use (≥1 time per week) or a severe communication or thinking disorder

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Use of hormone replacement therapy
  • Use of medication that is not stable for at least 1 month prior to the test session
  • Regular drug use (≥1 time per week)
  • 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
  • Body weight >150 kg (maximum weight for the MRI scanner)
  • Postmenopausal individuals
  • 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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 55 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

* 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.

A vizsgálat 4 csoportja

  • 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.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
STRAIN (STRessinpAIN): A Comprehensive Mapping of Stress System Interactions With Pain and Their Contribution to Extent and Chronification of Musculoskeletal Pain
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT06892977: ki vehet részt
Publikációk
A regiszteradat frissítve
2026. szeptember 21.