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(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis.


- candidate number7763
- NTR NumberNTR2216
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2010
- Secondary IDsNL31589.058.10 CCMO
- Public Title(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis.
- Scientific Title(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis.
- ACRONYMESPRIT Trial
- hypothesisPossibly 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.
- Healt Condition(s) or Problem(s) studiedLumbar stenosis, Surgical treatment, Neurogenic claudication, Nonoperative treatment
- Inclusion criteria1. 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 criteria1. Has a cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence);
2. Has Pagetís 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate31-dec-2012
- Target number of participants280
- InterventionsA 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.
- Primary outcome1. Zurich Claudication Questionnaire;
2. Shuttle walking test.
- Secondary outcome1. 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. Patientís, neurologistís, neurosurgeonís, GPís 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.
- TimepointsWritten 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. G.M. Overdevest
- CONTACT for SCIENTIFIC QUERIESdrs. G.M. Overdevest
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-feb-2010 - 26-feb-2010


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