Lumbar disc herniation Musculoskeletal Diseases Lumbar disc herniation
Conditions
Interventions
Two patient populations are being included in this study. Population 1 includes patients who are being surgically treated, and Population 2 includes patients who are being conservatively treated.
Po
Sponsors
Medical University of Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Population 1 – Patients being operatively treated 1. Patients with a lumbar disc herniation causing sensomotoric dysfunction in nerve root distribution areas L3 to S1 2. Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or significant motor deficit or signs of nerve root compression in the face of conservative treatment 3. An indication for surgical treatment according to the guidelines of DGNC and DGOOC 4. MRI determined pathology at treatment level that correlates to primary symptoms Population 2 – Patients being conservatively treated 1. Patients with a lumbar disc herniation causing sensomotoric dysfunction in nerve root distribution area L3 to S1 2. No urgent indication for surgical treatment according to the guidelines of DGNC and DGOOC 3. MRI determined pathology at treatment level that correlates to primary symptoms Population 1 and 2 1. Age between 18 and 65 years 2. Skeletally mature 3. Willing and able to understand the study and to provide informed consent to participate 4. Physically and mentally able to participate in the study, including study treatment and post-study treatment pain 5. Able to understand and to complete study-relevant questionnaires in German language
Exclusion criteria
Exclusion criteria: 1. Cardiac pacemaker 2. Pregnancy 3. Any degenerative muscular or neurological condition that would interfere with 4. Evaluation of outcome measures including but not limited to Parkinson's disease, amytrophic lateral sclerosis, multiple sclerosis, muscular dystrophy and myelopathic diseases of different causes myelopathy 5. Unable or unwilling to comply therapeutic instructions or to comply the follow-up visits at the study site 6. Active or chronic infection, systemic or local, systemic disease including HIV, AIDS, Hepatitis, Syphilis 7. Unable to undergo MRI 8. Active malignancy defined as a history of any invasive malignancy, except nonmelanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years neoplasia as the source of symptoms 9. Diabetes mellitus 10. Paget’s disease, osteomalacia, osteoporosis or other metabolic bone disease 11. Skin disease that influences sensory nerve function 12. Polyneuropathy 13. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis) 14. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia) and usage of anti-depressive drugs 15. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin 16. Recent or current history of substance abuse ( alcohol, narcotics, recreational drugs) 17. Pursuing personal litigation related to spinal diseases 18. Prisoner or ward of the state Radiological Exclusion Criteria 1. Previous or acute spondylodiscitis 2. Previous compression or burst fracture at the level(s) to be treated 3. Central canal stenosis causing radiculopathy or clinical myelopathy (by MRI) 4. A spinal tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cold detection threshold (CDT) is measured using the standardised quantitative sensory testing protocol at 24 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain, back specific function, work disability and patient's satisfaction are measured using the Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) at baseline, within 1 week, 2, 6, 12 and 24 months 2. Generic health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) is measured using EuroQoL-5Dimension (EQ-5D) at baseline, within 1 week, 2, 6, 12 and 24 months 3. Severity of depression and responsiveness to treatment is measured using the Beck Depression Inventory (BDI) at baseline, within 1 week, 2, 6, 12 and 24 months 4. Neuropathic pain components in patient with back pain are measured using the painDETECT questionnaire (PD-Q) at baseline, within 1 week, 2, 6, 12 and 24 months 5. Neurological status and the quality and quantity of current pain medication, including epidural injections and nerve block injections, are documented at baseline, within 1 week, 2, 6, 12 and 24 months 6. Sensory function is measured by Two-point-discrimination (2PD) at baseline, within 1 week, 2, 6, 12 and 24 months 7. Functionality is measured using the timed up and go test (TUG) at baseline, within 1 week, 2, 6, 12 and 24 months 8. Muscle force is tested by a manual muscle tester (MMT) at baseline, within 1 week, 2, 6, 12 and 24 months 9. Intraoperative problems such as surgery related- or device related complications and postoperative complications like re-operations, recurrent disc herniations, infection or bleeding are recorded continuously throughout the study period 10. Characteristics of disc herniation and sagittal alignment are measured using magnetic resonance imaging (MRI) at baseline, within 1 week, 2, 6, 12 and 24 months 11. Cytokinelevels and inflammation markers are measured using IL-6, IL-1b, TNFa, CRP and WBC at baseline, within 1 week, 2, 6, 12 and 24 months | — |
Countries
Austria
Outcome results
None listed