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NCT03832036 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03832036
Other study ID # 201170138
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date January 1, 2021

Study information
Verified date May 2022
Source Spine Centre of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Paraspinal Mapping and Quantitative Sensory Pain Test
Participants will be tested at baseline.

Locations
Country Name City State
Denmark Center for Rheumatology and Spine Diseases, Frederiksberg Hospital. Frederiksberg

Sponsors (4)
Lead Sponsor Collaborator
Spine Centre of Southern Denmark Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark, Frederiksberg University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing 8 week follow-up
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