Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

Phase 4

Terminated

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: physiotherapy; Procedure: Spacer

• Registration Number: NCT01057641
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Study Start: 2011-03
• Primary Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physiotherapy	physiotherapy	The control group will receive at least physiotherapy and physical therapy (e.g. massage and fango). Under inpatient conditions therapy will last for seven days. After discharge physical therapy has to be continued for 5 weeks. A schedule will ensure the consistency of the physical therapy. The inpatient-treatment can be repeated every 6 months if necessary.
Spacer	Spacer	Implantation of a percutaneously implanted interspinous device ("spacer")

Primary Outcome Measures

Name	Time	Method
Changes in subscores for bodily pain and physical function on SF-36	baseline, 6 months

Secondary Outcome Measures

Name	Time	Method
Physical function by applying ZCQ	baseline, 6 months
General health status (Quality of life) by applying SF-36	baseline, 6 months
Post-treatment patient satisfaction by applying ZCQ	baseline, 6 months
Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ)	baseline, 6 months
Measurement of walking distance	baseline, 6 months

Trial Locations

Locations (2)

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany

University Hospital of Cologne; 🇩🇪 Cologne, Germany