(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis.
- Conditions
- umbar stenosisNeurogenic claudicationSurgical treatmentNonoperative treatmentLumbale kanaalstenoseNeurogene claudicatioChirurgische behandelingNon-operatieve behandeling
- Registration Number
- NL-OMON27394
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 280
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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Zurich Claudication Questionnaire;<br /><br>2. Shuttle walking test.
- Secondary Outcome Measures
Name Time Method 1. Demographic data;<br /><br>2. Neurological/clinical investigations;<br /><br>3. Modified Roland Disabilty Questionnaire;<br /><br>4. Visual analogue scale (VAS) for Pain in back and leg;<br /><br>5. Perceived Recovery;<br /><br>6. SF-3630;<br /><br>7. Societal costs and utilities (EuroQol-5D, visual analogue scale);<br /><br>8. Complications;<br /><br>9. Re-operation incidence;<br /><br>10. Operative data;<br /><br>11. Imaging findings;<br /><br>12. Patient’s, neurologist’s, neurosurgeon’s, GP’s preference at baseline;<br /><br>13. Timed-up and go test;<br /><br>14. Short physical performance battery (SPPB);<br /><br>15. MicroFET (Force Evaluating and Testing);<br /><br>16. Grip strength;<br /><br>17. Accelerometry.