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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01057641
Recruitment Status : Terminated (low enrollment)
First Posted : January 27, 2010
Last Update Posted : November 6, 2016
Information provided by (Responsible Party):
Dr. Gregor Stein, 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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Procedure: Spacer Other: physiotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant in Comparison With the Best Non-operative Treatment of Lumbar Spine Stenosis
Study Start Date : March 2011
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Spacer
Implantation of a percutaneously implanted interspinous device ("spacer")
Procedure: Spacer
Implantation of a percutaneously implanted interspinous device (spacer)
Other Name: PIDLSS

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.
Other: physiotherapy
Other Name: PIDLSS

Primary Outcome Measures :
  1. Changes in subscores for bodily pain and physical function on SF-36 [ Time Frame: baseline, 6 months ]

Secondary Outcome Measures :
  1. Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) [ Time Frame: baseline, 6 months ]
  2. Physical function by applying ZCQ [ Time Frame: baseline, 6 months ]
  3. Post-treatment patient satisfaction by applying ZCQ [ Time Frame: baseline, 6 months ]
  4. General health status (Quality of life) by applying SF-36 [ Time Frame: baseline, 6 months ]
  5. Measurement of walking distance [ Time Frame: baseline, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057641

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University Hospital Cologne
Cologne, NRW, Germany, 50931
University Hospital of Cologne
Cologne, Germany, 50924
Sponsors and Collaborators
University of Cologne
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Principal Investigator: Thomas Kaulhausen, MD University Hospital of Cologne
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Responsible Party: Dr. Gregor Stein, Dr. med, University of Cologne Identifier: NCT01057641    
Other Study ID Numbers: PI-DLSS
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: November 6, 2016
Last Verified: November 2016
Keywords provided by Dr. Gregor Stein, University of Cologne:
PIDLSS, Spacer
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases