A test procedure for the evaluation of cortical somatosensory evoked potentials as a measure of cortical excitability in people with chronic low back pain: an explorative study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015109

Enrollment

Registered

2018-08-01

Start date

2018-08-20

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

non-specific chronic low back pain M54.5

Interventions

Group 1: Measurment of cortical SEPs (somatosensory evoked potentials) after electrical stimualtion of the lower back with side-to-side comparison

Determination of cortical excitability by means of a paired-pulsed protocol with 40 and 50 ms interstimulus interval (ISI)

Determination of cortical single SEPs by electrical stimulation of the sural nerve. The data collected are compared with a norm collective of healthy subjects.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age: =18 years and = 50 years Sufficient cognitive and German language skills/ability to understand both oral and written instructions and to give informed consent. Intact skin on the lower back region. Successful thermal skin sensation test of either feet Diagnosis: CLBP with or without leg pain. For those with leg pain the back pain will have to be more dominant and the leg pain should not spread beyond the knee Duration of symptoms: = 6 months

Exclusion criteria

Exclusion criteria: ‘Red flags’ indicating serious spinal or peripheral nerve root pathologies or signs of malignancy, fracture, infection, inflammatory joint or bone disease any condition affecting sensation in the regions served by the sural nerve (bilaterally) previous surgery with metal implants in the trunk, pelvis or lower limbs pregnancy (Stöhr et al., 2013) heart pacemaker (Stöhr et al., 2013) Allergy to disinfection spray (Octenisept, Schuelke, Germany), skin preparation paste (Skin Pure Fo20, Nihon Kohden, Tokyo, Japan), adhesive conductive paste (Elefix F509, Nihon Kohden, Tokyo, Japan), shampoo (Sebamed Trockene Haut Pflege Shampoo, Sebapharma GmbH & Co.KG, Germany) skin cream (Sebamed Lotion, Sebapharma GmbH & Co.KG, Germany) Communicable foot condition Current or history of altered thermal sensation of either foot Unsuccessful thermal skin sensation test of the foot

Design outcomes

Primary

Measure	Time frame
Single SEP latencies and amplitudes of N20, P30 in side-to-side comparisons; all values will be determined after the recording is finished.	—

Secondary

Measure	Time frame
quotient of (N2/P2)/(N1/P1) amplitudes with values >1 displaying cortical facilitation and values <1 cortical inhibition	—

Countries

Germany

Contacts

Public ContactKatja Ehrenbrusthoff

Hochschule für Gesundheit

katja.ehrenbrusthoff@hs-gesundheit.de0049 234 77727626

Outcome results

None listed

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