Characterisation of changes in pro- and anti-inflammatory mediators in serum, assessment of scale-based functional status and quantitative sensory testing as well as quantitative MRI, magnetoencephalography (MEG) and optical coherence tomography (OCT) in subjects with chronic refractory back and/or leg pain syndrome under spinal cord stimulation therapy

Characterisation of changes in pro- and anti-inflammatory mediators in serum, assessment of scale-based functional status and quantitative sensory testing as well as quantitative MRI, magnetoencephalography (MEG) and optical coherence tomography (OCT) in subjects with chronic refractory back and/or leg pain syndrome under spinal cord stimulation therapy - Objective outcome scores with SCS therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035826

Enrollment

Registered

2025-01-21

Start date

2025-01-16

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

Chronic refractory back and/or leg pain syndrome

Interventions

Group 1: Subjects with chronic refractory back and/or leg pain syndrome who receive spinal cord stimulation (SCS) should undergo additional measurements/examinations prior to surgery, 3, 6 and 12 mont

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of chronic refractory pain syndrome (back and/or leg pain) requiring implantation of an SCS system - Verbal and written declaration of consent

Exclusion criteria

Exclusion criteria: - Neurological disorders, current and/or in the past (incl. severe traumatic brain injury) - History or current abuse of or dependence on psychotropic substances including alcohol (except nicotine) - Serious psychiatric disorders in the past or currently - Serious physical illnesses, in particular unstable cardiovascular diseases - Pregnancy (female gender) - underlying malignant disease and acute and/or chronic infections - Additionally for the OCT examination: Known ocular diseases that lead to a change in the neurosensory retina or optic nerve, clinically significant opacities of the cornea, lens and/or vitreous body and intraocular surgery within the last 3 months - Additionally for MRI examinations: Contraindications for MRI; contraindications for contrast administration - Additionally for MEG examinations: Contraindications for MEG

Design outcomes

Primary

Measure	Time frame
Prior to surgery and 3, 6 and 12 months after the surgery, back/leg pain is assessed using the Visual Analogue Scale (VAS). In addition, sleep quality is measured using the Pittsburgh Sleep Quality Inventory (PSQI), depressive mood using the Beck Depression Inventory (BDI) and quality of life using the Oswestry Disability Index (ODI) is also recorded. At the same time points, inflammatory mediators in the blood are determined (BDNF, BNDP, interleukins, MMP, MIP) and MRI and OCT and MEG are performed to determine structural and functional changes in the brain and the fundus of the eye. Quantitative sensorimotor testing (QST) is also carried out.	—

Measure

Time frame

Prior to surgery and 3, 6 and 12 months after the surgery, back/leg pain is assessed using the Visual Analogue Scale (VAS). In addition, sleep quality is measured using the Pittsburgh Sleep Quality Inventory (PSQI), depressive mood using the Beck Depression Inventory (BDI) and quality of life using the Oswestry Disability Index (ODI) is also recorded. At the same time points, inflammatory mediators in the blood are determined (BDNF, BNDP, interleukins, MMP, MIP) and MRI and OCT and MEG are performed to determine structural and functional changes in the brain and the fundus of the eye. Quantitative sensorimotor testing (QST) is also carried out.

—

Countries

Germany

Contacts

Public ContactSteffen Brenner

Universitätsmedizin Mannheim

steffen.brenner@umm.de+49 621 383 4417

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 6, 2026