Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

Each patient will be assigned to one of the two groups: IDB or Sham. On the day of the procedure, an IV will be inserted in pre-procedural area and patient transported to the procedure room. The procedure will be completed under fluoroscopy in prone position. Patients will be given 1-4 mg of midazolam for relaxation before the procedure and, if needed, 50-100 mcg of fentanyl IV during the procedure. The patients will be randomly assigned to treatment or placebo using computer-generated codes maintained in sequentially numbered opaque envelopes. The physician performing procedure will be informed of the assignment. In IDB group, guided by the fluoroscopic imaging, two transdiscal probes will be positioned in the posterior annulus using a posterolateral, oblique approach. First, two electrically insulated 17G transdiscal introducers will be used to gain an access to the disc space. Than, two radiofrequency probes will be positioned through each of the introducers bilaterally to create a bipolar configuration. Placement of the transdiscal probes within the disc annulus will be confirmed using oblique, lateral, and anterior-posterior fluoroscopic images. Sham group will have their introducers and electrodes positioned just outside of the disc. This will also be documented using fluoroscopy. Investigator will attach the electrodes to inactive heater control device that provide a similar auditory and visual experience for both the patient. Patients will therefore remain blinded to actual treatment and physician performing procedure will not be involved in patient's follow-up. Patients will be awake and communicating with the physician conducting the procedure and if pain in legs is present and increases during the procedure, the heating protocol will be stopped. Following completion of procedure the patient will be transferred to recovery and monitored for 45 minutes, then discharged home with instructions. The patients will be followed over a period of 12 months.

Back Pain

• Device: The Transdiscal Radiofrequency Annuloplasty
  Adjustment in dosage form, frequency and or duration.
  Other Name: Intradiscal Biacuplasty Active Comparator
• Device: The Transdiscal Radiofrequency Annuloplasty
  interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
  Other Name: Sham: Placebo Comparator

• Active Comparator: Intradiscal Biacuplasty

  Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.

  After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure.

  Intervention: Device: The Transdiscal Radiofrequency Annuloplasty
• Placebo Comparator: Sham

  The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.

  The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB.

  Intervention: Device: The Transdiscal Radiofrequency Annuloplasty

Inclusion Criteria:

• The inclusion criteria will be as follows:

  • Age 18 + years
  • History of chronic low back pain unresponsive to nonoperative care (including physical therapy and anti-inflammatory medication) for longer than 6 months of at least 5 on VAS
  • No surgical interventions within the last 3 months
  • Back pain more than leg pain which is commonly exacerbated by sitting
  • Pain reproduction present on provocative discography in degenerated disc but not in control discs
  • Disc height at least 50% of adjacent control disc
  • Evidence of single level degenerative disc disease or two level disease without evidence of additional degenerative changes in other disc spaces on MRI

Exclusion Criteria:

• The exclusion criteria are :

  • Evidence of compressive radiculopathy with predominant leg pain
  • Nucleus pulposus herniation on the MRI
  • Disc bulges > 5 mm
  • Prior lumbar surgery of any kind
  • Presence of concordant cervical or thoracic pain
  • Symptoms or signs of the lumbar canal stenosis
  • Evidence of structural abnormality at the symptomatic level like spondylolisthesis
  • Chronic severe conditions such as rheumatoid arthritis and fibromyalgia
  • Patients with pending workers compensation claim, litigation or disability income remuneration
  • Psychological issues by exam or history
  • Beck Depression Inventory (BDI) >20
  • Pregnancy
  • Systemic infection or localized infection at the anticipated entry needle site
  • Allergies to contrast media or to any medication to be used in the procedure
  • Traumatic spinal fracture
  • History of coagulopathy, unexplained bleeding
  • Progressive neurological deficits
  • History of opioid abuse
  • Presence of free disc fragments on MRI
  • More than 2 discs degenerated on MRI
  • Immunosuppression (eg. AIDS, cancer, diabetes, other surgery within last 3 months)
  • Smoking
  • BMI (body mass index) >30 kg/m2
  • Subject unwilling to consent to the study
  • Participation in another investigation within 30 days of signing informed consent