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

May 4, 2022 updated by: Spine Centre of Southern Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with lumbar disc herniation
Diagnostic test: Paraspinal Mapping and Quantitative Sensory Pain Test
Participants will be tested at baseline.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spine Centre of Southern Denmark

Collaborators

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

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

February 5, 2019

First Posted (ACTUAL)

February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201170138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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