A Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix* Device to treat Chronic Discogenic Low Back

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Age between 18-66 years.
- One or two levels of lumbar degenerative disc disease on magnetic resonance imaging (MRI) scan with Pfirrmann grade 2, 3 or 4.
- Positive discography
- Predominant persistent, nociceptive low back pain that worsens with axial loading and improves with recumbence of at least 12 weeks duration.
- Failure to have symptoms resolved or reduced following at least 12 weeks conservative care (pain medication and/or physical therapy).
- Annulus must be competent as determined by lumbar discography
- Negative medial branches block results.
- Patients presenting with a baseline level scores evaluated by NRS of at least 5/10.
- Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation

Exclusion Criteria

- Radiculopathy caused by nerve root compression.
- Frank herniations, extruded or sequestered fragments, bulge/protrusions >3mm at any lumbar disc level.
- Greater than grade 4 annular tear (Modified Dallas Grading) at any lumbar disc level.
- Severe symptomatic central, foraminal or lateral recess stenosis, spondylolysis, spondylolisthesis, acute fractures, or ankylosing spondylitis at any lumbar disc level.
- Coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation.
- Active infection, systemic or localized; any disease process or condition that may make the effect of the treatment difficult to evaluate (e.g. cancer, substance abuse, etc.)
- Previous surgery at any lumbar disc level.
- Disc height less than 5mm at the symptomatic level, or less than 50% of the highest lumbar disc
- Presence of Schmorls nodes at the implanted level.
- Females of childbearing age that are known to be pregnant or wishing to be pregnant during the study.
- Psychological disorders or factors that may impact upon treatment outcomes or compliance (e.g. severe depressions).
- Failure to understand informed consent or participation in any other clinical study.
- BMI (Body Mass Index (kg/m2) of >= 35

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Lumbar pain intensity measured on Numeric Rating Scale at baseline and 6 months<br /><br>post-treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Changes in disability: Owestry Disability Index,<br /><br>2. Changes in health related quality of life: EuroQualityOfLife-5 dimensions<br /><br>questionnaire,<br /><br>3. Reliance on medication to relieve pain: type and dose of analgesics<br /><br>4. Device-related adverse events assessed up to one year</p><br>