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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Implantation of a percutaneously implanted interspinous device (spacer)
physiotherapy
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
University Hospital of Cologne
Cologne, Germany
Changes in subscores for bodily pain and physical function on SF-36
Time frame: baseline, 6 months
Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ)
Time frame: baseline, 6 months
Physical function by applying ZCQ
Time frame: baseline, 6 months
Post-treatment patient satisfaction by applying ZCQ
Time frame: baseline, 6 months
General health status (Quality of life) by applying SF-36
Time frame: baseline, 6 months
Measurement of walking distance
Time frame: baseline, 6 months
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