The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation

The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03832036

Enrollment

102

Registered

2019-02-06

Start date

2018-10-01

Completion date

2021-01-01

Last updated

2025-07-08

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

Conditions

Back Pain, Lumbar Disc Herniation, Pain, Spinal Diseases, Surgery

Keywords

Electromyography, Paraspinal Mapping, Quantitative clinical tests, Conditioned pain modulation, Temporal pain summation, Pain threshold, Pain tolerance

Brief summary

This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Detailed description

150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Interventions

DIAGNOSTIC_TESTParaspinal Mapping and Quantitative Sensory Pain Test

Participants will be tested at baseline.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical and radiologically diagnosed lumbar disc herniation. * Low back pain with pain below the knee or anterior thigh pain in one or both legs. * Dermatomal leg pain. * Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).

Exclusion criteria

* History of previous lumbar spine surgery. * Surgery in general in the past 4 months. * Current use of anticoagulants. * Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.

Design outcomes

Primary

Measure	Time frame
The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing	8 week follow-up

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026