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

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ClinicalTrials.gov Identifier: NCT03832036
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Frederiksberg University Hospital
Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark
Odense University Hospital
Information provided by (Responsible Party):
Spine Centre of Southern Denmark

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pain Lumbar Disc Herniation Back Pain Spinal Diseases Surgery Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with lumbar disc herniation Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test
Participants will be tested at baseline.


Outcome Measures
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Primary Outcome Measures :
  1. The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing [ Time Frame: 8 week follow-up ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832036


Contacts
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Contact: Johanne B Filtenborg, M.Sc. +4538164167 johanne.brinch.larsen@rsyd.dk

Locations
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Denmark
Center for Rheumatology and Spine Diseases, Frederiksberg Hospital. Recruiting
Frederiksberg, Denmark, 2000
Contact: Johanne B Filtenborg, M.Sc.         
Sponsors and Collaborators
Spine Centre of Southern Denmark
Frederiksberg University Hospital
Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark
Odense University Hospital
Investigators
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Principal Investigator: Johanne B Filtenborg, M.Sc. Spine Centre Southern Denmark
Study Director: Berit Schiøttz-Christensen, MD Spine Centre Southern Denmark
Study Chair: 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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier: NCT03832036    
Other Study ID Numbers: 201170138
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spine Centre of Southern Denmark:
Electromyography
Paraspinal Mapping
Quantitative clinical tests
Conditioned pain modulation
 Temporal pain summation
Pain threshold
Pain tolerance
Additional relevant MeSH terms:
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Spinal Diseases
Hernia
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases