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Caution : Federal Law (USA) restricts the sale of these devices to or by the order of a physician.

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Patient selection for disc biacuplasty

Inclusion Criteria

Patients must meet all of the inclusion criteria:

• Criteria for discogenic pain satisfied, viz
  • Predominant axial / mechanical pain
  • Demonstration of positive concordant pain of intensity >6/10 during provocative lumbar discography at 1 or 2 disc levels at low pressures (<50 psi) with negative control disc at one and preferably two adjacent levels and sham pressurization
  • Physical examination
• Chronic pain (>6 months)
• Age greater than 18 years
• At least 50% preserved disc height
• Failure to achieve adequate improvement with comprehensive non-operative treatment including: non-steroidal anti-inflammatory drugs, physical therapy, and fluoroscopically guided epidural steroid injection in and around the area of pathology
  
• Other possible causes of low back pain have been ruled out e.g. failure to obtain prolonged improvement (> 14 days) from facet injections, sacroiliac joint injections or RF rhizotomies

Exclusion Criteria

Patients will be excluded if they meet any of the following criteria:

• Neurological deficit
• Intervertebral disc herniations greater than 4mm
• Extruded/sequestered intervertebral disc herniations
• Spinal pathology that may impede recovery e.g. spina bifida occulta, spondylolisthesis at the painful segmental level, or scoliosis
• Moderate to severe foraminal or central canal stenosis
• Pregnancy
• Existing endplate damage or Schmorl’s nodes
• Greater than grade 4 annular tear (Modified Dallas Grading)
• Systemic infection or localized infection at the anticipated introducer entry site
• History of coagulopathy or unexplained bleeding

Relative Contraindications

• Body Mass Index greater than 29.9 (obese)
• Irreversible psychological barriers to recovery
• Prior lumbar spine surgery
• Radiculopathy
• Immunosuppression (e.g. AIDS, cancer, diabetes, other surgery within last 3 months)

Potential risks

As with any medical procedure there are risks. However, since the biacuplasty procedure is minimally invasive, the risks are lower than surgery.

Potential risks include:

• In rare cases, radiofrequency procedures have caused burns at the site of insertion of the introducer needles
• Due to the rarity of these cases it is believed that such events may be caused by operator error
• Nerve injury is a potential risk of the procedure. However, having the patient in a state of conscious sedation, where they are able to verbally communicate any unwanted sensations reduces the risk of this occurrence