No registrations found.
ID
Source
Brief title
Health condition
Lumbar stenosis
Neurogenic claudication
Surgical treatment
Nonoperative treatment
Lumbale kanaalstenose
Neurogene claudicatio
Chirurgische behandeling
Non-operatieve behandeling
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Zurich Claudication Questionnaire;
2. Shuttle walking test.
Secondary outcome
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.
Background summary
N/A
Study objective
Possibly 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 in a smaller population of patients with persisting complaints is a more (cost)effective approach.
Study design
Written questionnaires at initial visit, during randomization and at 4, 12, 26, 38, 52, 104, 156, 208, 260 weeks after randomization.
Outpatient clinic physical examination at randomization and 12, 26, 52, 104, 260 weeks after randomization.
Intervention
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 in a smaller population of patients with persisting complaints.
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
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2099 |
| NTR-old | NTR2216 |
| CCMO | NL31589.058.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36278 |