lumbar spinal stenosis narrowing of spinal canal
Conditions
Interventions
All surgeons involved with the Size-study are highly experienced in both
interventions. Both techniques are part of the Dutch training program for
neurosurgeons.
The intervention that is to be inve
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - At least 12 weeks of complaints of Intermittent Neurogenic Claudication - Indication for an operation - Magnetic Resonance Imaging demonstrating Lumbar Spinal Stenosis - Age above 40 years - Sufficient knowledge of the Dutch language in order comprehend the questionnaires and patient information. - Written informed consent given
Exclusion criteria
Exclusion criteria: - History of lumbar surgery - More than 2 lumbar levels operation or needed discectomy - Degenerative spondylolisthesis greater than grade I (on a scale of I to IV) - Scoliosis or disc herniation - Severe comorbid medical disorder (American Society of Anesthesiologists > 3) - Serious psychopathologic disorder - Pregnancy - Active malignancy - Plans to move abroad during study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5.1.1 Main study parameter/endpoint The primary outcome measurement will be the Modified Roland-Morris Disability Questionnaire (MRMDQ). This is a 24-point Dutch questionnaire that is designed to assess the physical disability in patients, due to lower back pain. The participant will complete the questionnaire and the sum of the scores reflects the invalidity in daily life. The score can vary from 0 (no restriction) to 24 (severe limitations). s | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale for leg and back pain The pain intensity in both legs (affected and non-affected) and back will be rated on an 11-point scale. A score of 0 represents *no pain*, while a score of 10 represents *the most terrible pain I can imagine*. The outcome is the average pain intensity in the legs and back. During each visit the participants are asked to rate the pain for both legs and one for back pain, if applicable. The patient is not entitled to see the pain score indicated during previous visit(s). Physical examination consisting of: - Neurologic examination A straight leg raise test will be performed. Furthermore, strength, sensibility and reflexes will be assessed of the lower extremity. - Timed-up and go test The TUG test will be performed in a standardized manner On *Go,* the patient gets up and walks as fast as possible (no running) to a marked line on the floor at a distance of 3*m. On the line, they turn around by 180° and return to the chair and sit down as quickly as possible. The time between getting up and sitting down again will be recorded in seconds using a stopwatch. The patients are allowed to wear their regular shoes and use a walking aid, if required. Raw TUG test times will be transformed into T-scores using age- and sex-adjusted norms. The TUG app is validated for disc but not for stenosis yet and will be conducted in this study. - 6-minute walk test (6MinWT) The 6 -minute walk test is performed to assess the gait pattern, walking speed and physical endurance of patients. The test will be executed on a ground level, where the walked distance can easily be measured, f.i. in a hall with adequate walking space. The patient will be requested to walk at such a speed that at the end of the 6 minutes, the patient will have the feeling of maximum output. At the end of the 6 minutes, the distance will be measured. During the walking test, the patient is permitted to use a walking aid and/or an orthosis. - Timed | — |
Countries
Netherlands
Outcome results
None listed