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

Not Applicable

• Conditions: non-specific chronic low back pain; M54.5; Low back pain

• Registration Number: DRKS00015109
• Lead Sponsor: Hochschule für Gesundheit Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study Completion: 2019-04-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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

‘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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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