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NCT Number: NCT03832036

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

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.

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Key information

Conditions

Pain Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Disc Herniation Musculoskeletal Diseases Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.

Frederiksberg, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paraspinal Mapping and Quantitative Sensory Pain Test

Diagnostic Test

Participants will be tested at baseline.

Primary outcomes

  1. The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing

    Time frame: 8 week follow-up

Sponsors and collaborators

Lead sponsor

Spine Centre of Southern Denmark

Other

Collaborators

  • Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark
  • Frederiksberg University Hospital
  • Odense University Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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