Lumbar Spine Stenosis Central Canal Clinical Trial
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
| Verified date | June 2013 |
| Source | Napa Pain Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Napa Pain Institute | Napa | California |
| Lead Sponsor | Collaborator |
|---|---|
| Napa Pain Institute | Vertos Medical, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Week 6 to 12 prior to cross-over | No |
| Primary | 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. | Week 6 to 12 & Year One After Sham to mild x-over | No |
| Primary | 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. | Baseline and Year 1 | No |