Lumbar stenosis Neurogenic claudication Surgical treatment Nonoperative treatment Lumbale kanaalstenose Neurogene claudicatio Chirurgische behandeling Non-operatieve behandeling
Conditions
Interventions
A 6 months prolonged conservative treatment approach with a standardized exercise protocol, education/counseling by the general practitioner, prescription of analgesics and eventually delayed surgery
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: 1. At least 50 years old; 2. At least 3 months intermittent neurogenic claudication, as noted by leg/buttock/groin pain with or without back pain or fatigue in the legs provoked by walking. Leg/buttock/groin pain or fatigue needs to be strongly relieved when flexed such as when sitting in a chair; 3. Has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or more levels confirmed by MRI; 4. Has a regular indication for surgical intervention of INC; 5. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Has a cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence); 2. Has Paget’s disease, severe osteoporosis or metastasis to the vertebrae; 3. Has significant scoliosis (Cobb angle > 25 degrees); 4. Has a Body Mass Index > 40 kg/m2; 5. Has previously had a laminectomy at the same level, has degenerative or lytic spondylolisthesis grade >1 (on a scale 1 to 4) at the affected level or has significant instability of the lumbar spine; 6. Has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study (e.g. severe ischemic heart disease, musculoskeletal or neurological conditions impairing walking ability, cognitive impairment (MMSE <25 points); 7. Unable to read or write Dutch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Zurich Claudication Questionnaire; 2. Shuttle walking test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Demographic data; 2. Neurological/clinical investigations; 3. Modified Roland Disabilty Questionnaire; 4. Visual analogue scale (VAS) for Pain in back and leg; 5. Perceived Recovery; 6. SF-3630; 7. Societal costs and utilities (EuroQol-5D, visual analogue scale); 8. Complications; 9. Re-operation incidence; 10. Operative data; 11. Imaging findings; 12. Patient’s, neurologist’s, neurosurgeon’s, GP’s preference at baseline; 13. Timed-up and go test; 14. Short physical performance battery (SPPB); 15. MicroFET (Force Evaluating and Testing); 16. Grip strength; 17. Accelerometry. | — |
Contacts
Public ContactG.M. Overdevest
Albinusdreef 2
Outcome results
None listed