Lumbar Spine Stenosis Central CanalNCT01129921

Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis

A study testing Percutaneous Lumbar Decompression in people with Lumbar Spine Stenosis Central Canal, run by Napa Pain Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lumbar Spine Stenosis Central Canal
What is being tested?: Percutaneous Lumbar Decompression
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Oct 2011
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
Central canal cross sectional area clearly reduced per MRI/CT report.
If present, anterior listhesis ≤ 5.0mm (preferred) and stable.
Able to walk at least 10 feet unaided before being limited by pain.

Show all 9Show fewer

Available to complete 26 weeks of follow-up.
A signed Informed consent Form is obtained from the subject.
Adults at least 18 years of age.

Who cannot join

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Disk 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.

Show all 13Show fewer

Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory (NSAID) within five days of treatment.
Epidural steroid administration within prior 3 weeks(of procedure or sham)
Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
Dementia and/or inability to give informed consent.
Pregnancy and/or breastfeeding.
On Workman's Compensation or considering litigation associated with back pain.

Trial locations and contacts

1 site in 1 country.

United States1 site

Napa Pain Institute
Napa, California, 94558

Other trials in United States

About this study

Official title: Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis

Conditions: Lumbar Spine Stenosis Central Canal
Being tested: Percutaneous Lumbar Decompression, Sham lumbar decompression
Keywords: Lumbar Spine Stenosis, Decompression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous Lumbar DecompressionDevice
Also called mild® Device Kit percutaneous decompression
Fluoroscopic percutaneous lumbar decompression of the central spinal canal
Sham lumbar decompressionDevice
Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.

Study groups in NCT01129921
Study group	Role	What they receive
Decompression with mild® Device Kit	Active comparator	Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s). Receives: Device: Percutaneous Lumbar Decompression
Sham lumbar decompression	Sham comparator	Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue. Receives: Device: Sham lumbar decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analog Scale (VAS) <=4
Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.
Measured: Week 6 to 12 prior to cross-over
Visual Analog Scale (VAS) <=4
VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.
Measured: Week 6 to 12 & Year One After Sham to mild x-over
Visual Analog Scale (VAS) Mean Improvement
VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.
Measured: Baseline and Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2011

First posted25 May 2010 (estimated)
Study startApr 2010
Primary completionOct 2011
Study completionOct 2011

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 Spine Stenosis Central CanalStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01129921
Sponsor's protocol ID: Protocol #G01
Status last verified: Jun 2013
First submitted: 30 Apr 2010
Last updated: 16 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis
ClinicalTrials.gov ID: NCT01129921
Acronym / sponsor ID: Protocol #G01
Conditions: Lumbar Spine Stenosis Central Canal
Keywords: Lumbar Spine Stenosis, Decompression
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Napa Pain InstituteUniversity, hospital or other
Collaborators: Vertos Medical, Inc.
Study start: Apr 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 25 May 2010 (estimated)
Results: Posted 16 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Decompression with mild® Device Kit	Active comparator	Device: Percutaneous Lumbar DecompressionFluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).
Sham lumbar decompression	Sham comparator	Device: Sham lumbar decompressionSham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Symptomatic and lumbar spine stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy and Oswestry Disability Index (ODI) Score of >20%.
Radiologic evidence of LSS, ligamentum flavum hypertrophy (typically > 2.5mm)confirmed by pre op MRI and/or CT.
Central canal cross sectional area clearly reduced per MRI/CT report.
If present, anterior listhesis ≤ 5.0mm (preferred) and stable.

Key exclusion criteria (13 listed)

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Disk 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
Percutaneous Lumbar DecompressionAlso: mild® Device Kit percutaneous decompressionFluoroscopic percutaneous lumbar decompression of the central spinal canal	Device	Decompression with mild® Device Kit
Sham lumbar decompressionSham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.	Device	Sham lumbar decompression

Primary outcome

Visual Analog Scale (VAS) <=4
Time frame: Week 6 to 12 prior to cross-over
Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a "mild" pain score of 1-3 points and a "moderate to severe" pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.
Visual Analog Scale (VAS) <=4
Time frame: Week 6 to 12 & Year One After Sham to mild x-over
VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the "moderate to severe" categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below.
Visual Analog Scale (VAS) Mean Improvement
Time frame: Baseline and Year 1
VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.

Results and safety

Results posted to the registry on 16 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Percutaneous Decompression Procedure Only	20	20
Sham Then Percutaneous Decompression With Mild	20	20

Primary outcome: Visual Analog Scale (VAS) <=4

Time frame: Week 6 to 12 prior to cross-over. Number. Unit: participants

Measure	Mild Procedure Group 1 n = 20	Sham Procedure Group 2 Prior to Cross-over n = 20
Value	11 (2.1)	2 (1.8)

Population analysed: All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis.

Primary outcome: Visual Analog Scale (VAS) <=4

Time frame: Week 6 to 12 & Year One After Sham to mild x-over. Number. Unit: participants

Measure	Mild Group 1 Year-1 Cohort n = 18	Sham Group 2 Year-1 Cohort After X-over to Mild n = 13
Week 6-12	9	5
Year 1	12	5

Population analysed: Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild.

Primary outcome: Visual Analog Scale (VAS) Mean Improvement

Time frame: Baseline and Year 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Percutaneous Decompression Procedure Only n = 18	Sham Then Percutaneous Decompression With Mild n = 13
Value	2.3 (2.1)	2.2 (2.9)

Population analysed: All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year.

Adverse events

Time frame: Throughout study to Year One. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild Procedure	0 of 20 (0%)	0 of 20 (0%)	Not reported
Sham Procedure With Optional Crossover to Mild Post-unblinding	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a small series with challenging patient retention, particularly in the sham arm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Eric Grigsby, MD principal investigator

Napa Pain Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Lumbar Decompression in people with Lumbar Spine Stenosis Central Canal, run by Napa Pain Institute at 1 site 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 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 16 Jul 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?

Visual Analog Scale (VAS) <=4 (time frame: Week 6 to 12 prior to cross-over). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01129921.

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 16 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.