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Predictive Evidence Driven Intelligent Classification Tool for Low Back Pain

Predictive Evidence Driven Intelligent Classification Tool for Low Back Pain - PREDICT-LBP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030518
Enrollment
400
Registered
2022-11-18
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54.5

Interventions

Group 1: Patients with non-specific low back pain Data will be collected relating to nervous system adaptation (pain thresholds, temporal summation, brain resting state functional connectivity and re

Sponsors

Hochschule für Gesundheit
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for both LBP and matched-controls: adults aged 18 to 55 years, and being fully conversant in German or English. Inclusion criterion for LBP: pain localised below the costal margin and above the inferior gluteal folds, with or without leg pain.

Exclusion criteria

Exclusion criteria: Exclusion criteria for both LBP and matched-controls will be: Known diagnosis of cancer, cauda equina syndrome, vertebral fracture, vertebral or intervertebral disc infection or spondyloarthritis, diagnosed radiculopathy or severe spinal stenosis, known (i.e. previously diagnosed) severe anatomical spinal changes: grade IV spondylolisthesis, severe deformity (e.g. hemivertebrae, scoliosis > 50 degrees) requiring more than two prior medical specialist consultations, previous spine surgery, prior major head trauma or brain surgery, known neurological condition (i.e. cerebral palsy, dementia, epilepsy, motor neurone disease, multiple sclerosis, Parkinson’s disease, spinal muscular atrophy, stroke, polyneuropathy), known major psychiatric disorder (i.e. mania, bipolar affective disorder, major depressive disorder, severe personality disorder, severe anxiety disorder, severe obsessive-compulsive disorder), current pregnancy or up to 6 months post-pregnancy, any further absolute contraindications for brain or spine MRI (cardiac pacemakers, metal implants and foreign bodies, middle ear implants, drug pumps, electronic stimulation devices). For the pain-free control group, the following additional exclusion criteria will be applied: current spinal (neck, upper back, or low back) pain impacting function (self-report), back pain lasting for more than 24 hours within the last year (except for muscle soreness related to physical activity or exercise), previously, at any point, missed days from work due to LBP, previously, at any time, consulted a health professional for the treatment of LBP (e.g. physiotherapist and general practitioner).

Design outcomes

Primary

MeasureTime frame
In this cross-sectional study (1 measurement time-point per person) the following variables will be measured: Nervous system adaptation (pain thresholds, temporal summation, brain resting state functional connectivity and regional volumes via magnetic resonance imagine [MRI]), spinal tissue (intervertebral disc composition and morphology, vertebral fat fraction and paraspinal muscle size and composition via MRI), psychosocial factors (depression, anxiety, social isolation), other musculoskeletal pain locations, standard outcome measures to describe the collective

Secondary

MeasureTime frame
not applicable: cross-sectional study; the collected data (see primary outcome field) are to be classified into sub-groups using data-science methods.

Countries

Germany

Contacts

Public ContactDaniel Belavy

Hochschule für Gesundheit

Daniel.Belavy@hs-gesundheit.de+49234777275051832

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026