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

NCT03832036 | Completed

• 1 other identifier: 201170138
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing

  8 week follow-up

Study Arms (1)

Patients with lumbar disc herniation

EXPERIMENTAL

Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test

Interventions

Paraspinal Mapping and Quantitative Sensory Pain Test DIAGNOSTIC_TEST

Participants will be tested at baseline.

Patients with lumbar disc herniation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• Frederiksberg University Hospital: collaborator
• Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Pain; Intervertebral Disc Displacement; Back Pain; Spinal Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• Johanne B Filtenborg, M.Sc.

  Spine Centre Southern Denmark

  PRINCIPAL INVESTIGATOR

• Berit Schiøttz-Christensen, MD

  Spine Centre Southern Denmark

  STUDY DIRECTOR

• Søren O'Neill, DC

  Spine Centre Southern Denmark

  STUDY CHAIR

• Kirstine Amris, MD

  The Parker Institute, Frederiksberg Hospital

  STUDY CHAIR

• Gilles Fournier, MD, DC

  Center for Rheumatology and Spine Diseases, Frederiksberg Hospital

  STUDY CHAIR

• Andrew J Haig, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: February 6, 2019
• Study Start: October 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

DK (1)