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

• Sponsor: Napa Pain Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01129921
• Collaborator: Vertos Medical, Inc. (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spine Stenosis Central Canal	Device: Percutaneous Lumbar Decompression; Device: Sham lumbar decompression	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Decompression with mild® Device Kit Fluoroscopically guided percutaneous lumbar decompression using the Vertos mild® Device Kit for bone and tissue removal to decompress the targeted stenosed level(s).	Device: Percutaneous Lumbar Decompression; Fluoroscopic percutaneous lumbar decompression of the central spinal canal; Other Names: mild® Device Kit percutaneous decompression
Sham Comparator: Sham lumbar decompression Sham procedure of fluoroscopically guided percutaneous placement of mild® Device Kit instrumentation with no removal of bone or tissue.	Device: Sham lumbar decompression; Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale (VAS) <=4 [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.

2. Visual Analog Scale (VAS) <=4 [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.

3. Visual Analog Scale (VAS) Mean Improvement [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Napa Pain Institute	Napa	California	United States	94558

Sponsors and Collaborators

• Napa Pain Institute
• Vertos Medical, Inc.

Investigators

• Principal Investigator: Eric Grigsby, MD, Napa Pain Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric J. Grigsby, MD, Founder / Medical Director, Napa Pain Institute
• ClinicalTrials.gov Identifier: NCT01129921
• Other Study ID Numbers: Protocol #G01
• First Posted: May 25, 2010
• Last Update Posted: Jul 16, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Eric J. Grigsby, MD, Founder / Medical Director, Napa Pain Institute: Lumbar Spine Stenosis; Decompression
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details	Recruitment occurred 4-19-10 to 7-28-10
Pre-assignment Detail	Randomization occurred in blocks of four. After Week 6 post-treatment and prior to Week 12, Sham arm participants were allowed to have the mild decompression procedure with bone and tissue removal if they chose to have it.

Arm/Group Title	Percutaneous Decompression Procedure Only	Sham Then Percutaneous Decompression With Mild
Arm/Group Description	Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit	Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
Period Title: Prior to Sham Cross-over, 6-12 Weeks
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0
Period Title: Prior to Sham Cross-over, 6-12 Weeks
STARTED	20	20
COMPLETED	18	13
NOT COMPLETED	2	7

Baseline Characteristics

Arm/Group Title	Mild Procedure	Sham Procedure	Total
Arm/Group Description	Group 1: mild percutaneous decompression with removal of bone and tissue	Group 2: sham decompression with trocar placement and no bone or tissue removal	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 35%	8 40%	15 37.5%
>=65 years	13 65%	12 60%	25 62.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.3 (10.8)	67 (12.5)	66.6 (11.5)
Sex: Female, Male (Count of Participants)
Female	10 50%	7 35%	17 42.5%
Male	10 50%	13 65%	23 57.5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale (VAS) <=4
Description	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.
Time Frame	Week 6 to 12 prior to cross-over

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Mild Procedure Group 1	Sham Procedure Group 2 Prior to Cross-over
Arm/Group Description	Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.	Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
Measure Participants	20	20
Number [participants]	11 (2.1) 55%	2 (1.8) 10%

2. Primary Outcome

Title	Visual Analog Scale (VAS) <=4
Description	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.
Time Frame	Week 6 to 12 & Year One After Sham to mild x-over

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Mild Group 1 Year-1 Cohort	Sham Group 2 Year-1 Cohort After X-over to Mild
Arm/Group Description	Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit	Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
Measure Participants	18	13
Week 6-12	9 45%	5 25%
Year 1	12 60%	5 25%

3. Primary Outcome

Title	Visual Analog Scale (VAS) Mean Improvement
Description	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.
Time Frame	Baseline and Year 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Percutaneous Decompression Procedure Only	Sham Then Percutaneous Decompression With Mild
Arm/Group Description	Mild Group 1 Year-1 Cohort: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit	Sham Group 2 Year-1 Cohort: After cross-over to the active mild procedure study arm in which bone and tissue were removed using the mild device kit.
Measure Participants	18	13
Mean (Standard Deviation) [units on a scale]	2.3 (2.1)	2.2 (2.9)

Adverse Events

Time Frame	Throughout study to Year One
Arm/Group Title	Mild Procedure		Sham Procedure With Optional Crossover to Mild Post-unblinding
Arm/Group Description	percutaneous decompression with bone and tissue removal		Sham procedure includes percutaneous trocar placement with no tissue or bone removal.
All Cause Mortality
	Mild Procedure		Sham Procedure With Optional Crossover to Mild Post-unblinding
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mild Procedure		Sham Procedure With Optional Crossover to Mild Post-unblinding
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Mild Procedure		Sham Procedure With Optional Crossover to Mild Post-unblinding
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

This was a small series with challenging patient retention, particularly in the sham arm.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.