Clinical trial NCT03832036: The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation
Official title: The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Spine Centre of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Frederiksberg University Hospital
name: Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark
name: Odense University Hospital
First posted: 2019-02-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing
timeFrame: 8 week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Center for Rheumatology and Spine Diseases, Frederiksberg Hospital.
Study officials:
affiliation: Spine Centre Southern Denmark
name: Johanne B Filtenborg, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Spine Centre Southern Denmark
name: Berit Schiøttz-Christensen, MD
role: STUDY_DIRECTOR
affiliation: Spine Centre Southern Denmark
name: Søren O'Neill, DC
role: STUDY_CHAIR
affiliation: The Parker Institute, Frederiksberg Hospital
name: Kirstine Amris, MD
role: STUDY_CHAIR
affiliation: Center for Rheumatology and Spine Diseases, Frederiksberg Hospital
name: Gilles Fournier, MD, DC
role: STUDY_CHAIR
affiliation: University of Michigan
name: Andrew J Haig, MD
role: STUDY_CHAIR
References: