Lumbar Spinal Stenosis
Conditions
Keywords
PIDLSS, Spacer
Brief summary
Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, buttock or groin pain with or without lower back pain when walking a certain distance or reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of tissue or decrease of the disc height results in a relative laxity of the ligament structures and accelerates the degeneration of the spinal joints. As a therapy option, conservative therapy with oral analgesics and physical therapy is considered. This treatment can be intensified by adding epidural pain treatment. Is the conservative treatment not successful surgical intervention is necessary. In patients over 65 years of age operative decompression of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A relatively new therapy alternative is the interspinous process decompression (IPD). Studies have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.
Interventions
PROCEDURESpacer
Implantation of a percutaneously implanted interspinous device (spacer)
OTHERphysiotherapy
physiotherapy
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female over 50 years of age 2. One, two, or three segment degenerative lumbar spinal stenosis (DLSS) 3. Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit 4. Pain relief in inclination or sitting 5. Ability to walk over a distance of 50 m 6. Unsuccessful conservative therapy for 3 months under outpatient conditions 7. Informed consent
Exclusion criteria
1. Fixed motoric deficit 2. Cauda equina syndrome 3. Previous surgery of the lumbar spine 4. Severe osteoporosis of the vertebrae and/or of the hip 5. Spondylolisthesis more severe than Meyerding I (on scale of I-IV) 6. Metastasis of the vertebrae 7. Mentally disabled persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in subscores for bodily pain and physical function on SF-36 | baseline, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of walking distance | baseline, 6 months |
| Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) | baseline, 6 months |
| Physical function by applying ZCQ | baseline, 6 months |
| Post-treatment patient satisfaction by applying ZCQ | baseline, 6 months |
| General health status (Quality of life) by applying SF-36 | baseline, 6 months |
Countries
Germany
Outcome results
None listed