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

Completed

Conditions: intermittent neurogenic claudication
lumbar stenosis
10041543
10009720

Registration Number: NL-OMON36278

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

-at least 50 years old
-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
-has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at
one or more levels confirmed by MRI
-has a regular indication for surgical intervention of INC
-informed consent

Exclusion Criteria

-has a cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
-has Paget*s disease, severe osteoporosis or metastasis to the vertebrae
-has significant scoliosis (Cobb angle > 25 degrees)
-has a Body Mass Index > 40 kg/m2
-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
-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)
-unable to read or write Dutch

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Zurich Claudication Questionnaire<br /><br>- Shuttle walking test</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Demographic data<br /><br>- Neurological/clinical investigations<br /><br>- Modified Roland Disabilty Questionnaire<br /><br>- Visual analogue scale (VAS) for Pain in back and leg<br /><br>- Perceived Recovery<br /><br>- SF-3630<br /><br>- Societal costs and utilities (EuroQol-5D, visual analogue scale)<br /><br>- Complications<br /><br>- Re-operation incidence<br /><br>- Operative data<br /><br>- Imaging findings<br /><br>- Patients, neurologists, neurosurgeons, GPs preference at baseline<br /><br>- Timed-up and go test<br /><br>- Short physical performance battery (SPPB)<br /><br>- MicroFET (Force Evaluating and Testing)<br /><br>- Grip strength<br /><br>- Accelerometry</p><br>