Lumbar Spinal StenosisPhase 4NCT01057641
Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
A Phase 4 study testing Spacer and physiotherapy in people with Lumbar Spinal Stenosis, run by University of Cologne at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Spacer and physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2011to Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 50 years of age
- One, two, or three segment degenerative lumbar spinal stenosis (DLSS)
- Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit
- Pain relief in inclination or sitting
- Ability to walk over a distance of 50 m
- Unsuccessful conservative therapy for 3 months under outpatient conditions
- Informed consent
Who cannot join
- Fixed motoric deficit
- Cauda equina syndrome
- Previous surgery of the lumbar spine
- Severe osteoporosis of the vertebrae and/or of the hip
- Spondylolisthesis more severe than Meyerding I (on scale of I-IV)
- Metastasis of the vertebrae
- Mentally disabled persons
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50931
University Hospital of Cologne
Cologne, 50924
About this study
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
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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Spacer, physiotherapy
- Keywords
- PIDLSS, Spacer
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpacerProcedure or surgery
Also called PIDLSS
Implantation of a percutaneously implanted interspinous device (spacer)
physiotherapyOther
Also called PIDLSS
physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Spacer | Experimental | Implantation of a percutaneously implanted interspinous device ("spacer") Receives: Procedure: Spacer |
| physiotherapy | Other | 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. Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subscores for bodily pain and physical function on SF-36
Measured: baseline, 6 months
Secondary outcomes (5)
Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ)
Measured: baseline, 6 months
Physical function by applying ZCQ
Measured: baseline, 6 months
Post-treatment patient satisfaction by applying ZCQ
Measured: baseline, 6 months
General health status (Quality of life) by applying SF-36
Measured: baseline, 6 months
Measurement of walking distance
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMar 2011
- Primary completionMay 2016
- Study completionJun 2018 (estimated)
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregor Stein, University of Cologne
- Investigators
- Thomas Kaulhausen, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057641
- Sponsor's protocol ID
- PI-DLSS
- Status last verified
- Nov 2016
- First submitted
- 26 Jan 2010
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01057641
- Acronym / sponsor ID
- PI-DLSS
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- PIDLSS, Spacer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spacer | Experimental | Procedure: SpacerImplantation of a percutaneously implanted interspinous device ("spacer") |
| physiotherapy | Other | Other: physiotherapyThe 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. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female over 50 years of age
- One, two, or three segment degenerative lumbar spinal stenosis (DLSS)
- Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit
- Pain relief in inclination or sitting
- Ability to walk over a distance of 50 m
Key exclusion criteria (7 listed)
- Fixed motoric deficit
- Cauda equina syndrome
- Previous surgery of the lumbar spine
- Severe osteoporosis of the vertebrae and/or of the hip
- Spondylolisthesis more severe than Meyerding I (on scale of I-IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpacerAlso: PIDLSSImplantation of a percutaneously implanted interspinous device (spacer) | Procedure or surgery | Spacer |
| physiotherapyAlso: PIDLSSphysiotherapy | Other | physiotherapy |
Primary outcome
Changes in subscores for bodily pain and physical function on SF-36
Time frame: baseline, 6 months
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kaulhausen, MD principal investigator
University Hospital of Cologne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spacer and physiotherapy in people with Lumbar Spinal Stenosis, run by University of Cologne at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in subscores for bodily pain and physical function on SF-36 (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.