Lumbar Spinal StenosisNCT01076244
Vertos Mild - Post Market Patient Outcomes
A study testing Minimally Invasive Lumbar Decompression in people with Lumbar Spinal Stenosis, run by The Center for Pain Relief, Inc. at 2 sites in United States.
Trial summary
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Minimally Invasive Lumbar Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- Central canal cross sectional area clearly reduced per MRI/CT report
- If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
- Able to walk at least 10 feet unaided before being limited by pain
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- Available to complete 26 weeks of follow up
- A signed Consent Form is obtained from the patient
- Adults 18 years of age or older
Who cannot join
- Prior surgery at the intended treatment level
- Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- Disabling back or leg pain from causes other than lumbar spinal stenosis
- Disc protrusion or osteophyte formation severe enough to confound study outcome
- Facet hypertrophy severe enough to confound study outcome
- Bleeding disorders and/or current use of anti-coagulants
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- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
- Epidural steroids with 3 weeks prior to procedure
- Inability of patient to lie prone for any reason with anesthesia support
- Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
- Dementia and/or inability to give informed consent
- Pregnant and/or breastfeeding
- On workman's Compensation or considering litigation associated with back pain
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Center for Pain Relief, Inc.
Charleston, West Virginia, 25301
The Center for Pain Relief, Inc
Charleston, West Virginia, 25301
About this study
Official title: Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.
Read the detailed description
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Minimally Invasive Lumbar Decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Lumbar DecompressionProcedure or surgery
This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive lumbar decompression | Other | Not described Receives: Procedure: Minimally Invasive Lumbar Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as Measured by Visual Analog Scale (VAS).
A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
Measured: Baseline and six months
Secondary outcomes (3)
Improvement in Functional Mobility
Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.
Measured: baseline and month 6
Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.
Measured: Baseline and month 6
Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.
Measured: Baseline and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Pain Relief, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Vertos Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Timothy R Deer, MD, Principal investigator, Center for Pain Relief, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076244
- Sponsor's protocol ID
- #D1
- Status last verified
- Feb 2013
- First submitted
- 24 Feb 2010
- Last updated
- 2 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
- ClinicalTrials.gov ID
- NCT01076244
- Acronym / sponsor ID
- #D1
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Center for Pain Relief, Inc.University, hospital or other
- Collaborators
- Vertos Medical, Inc.
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 2 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.
Detailed description
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive lumbar decompression | Other | Procedure: Minimally Invasive Lumbar Decompression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- Central canal cross sectional area clearly reduced per MRI/CT report
- If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
Key exclusion criteria (13 listed)
- Prior surgery at the intended treatment level
- Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- Disabling back or leg pain from causes other than lumbar spinal stenosis
- Disc protrusion or osteophyte formation severe enough to confound study outcome
- Facet hypertrophy severe enough to confound study outcome
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 |
|---|---|---|
| Minimally Invasive Lumbar DecompressionThis minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves. | Procedure or surgery | Minimally invasive lumbar decompression |
Primary outcome
Pain as Measured by Visual Analog Scale (VAS).
Time frame: Baseline and six months
A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
3 secondary outcomes
Improvement in Functional Mobility
Time frame: baseline and month 6
Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
Time frame: Baseline and month 6
Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
Time frame: Baseline and month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Timothy R Deer, MD principal investigator
Center for Pain Relief, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Lumbar Decompression in people with Lumbar Spinal Stenosis, run by The Center for Pain Relief, Inc. at 2 sites in United States.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 2 Apr 2013. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain as Measured by Visual Analog Scale (VAS). (time frame: Baseline and six 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 2 Apr 2013.