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| Name | Class |
|---|---|
| Frederiksberg University Hospital | OTHER |
| Center for Rheumatology and Spine Diseases, Frederiksberg Hospital, Denmark | UNKNOWN |
| Odense University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with lumbar disc herniation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paraspinal Mapping and Quantitative Sensory Pain Test | Diagnostic Test | Participants will be tested at baseline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing | 8 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Rheumatology and Spine Diseases, Frederiksberg Hospital. | Frederiksberg | 2000 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2023 | Jul 1, 2025 |
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| SAP_001.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D007405 | Intervertebral Disc Displacement |
| D001416 | Back Pain |
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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