Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: The Transdiscal Radiofrequency Annuloplasty; The Transdiscal Radiofrequency Annuloplasty
Intervention description: Adjustment in dosage form, frequency and or duration.; interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lower Back Pain

Summary:

      Each patient was assigned to one of the two groups: IDB or Sham. On the day of the procedure,
      an IV was inserted in pre-procedural area and patient transported to the procedure room. The
      procedure will be completed under fluoroscopy in prone position. Patients were 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 was randomly assigned to treatment or placebo using
      computer-generated codes maintained in sequentially numbered opaque envelopes. The physician
      performing procedure was informed of the assignment. In IDB group, guided by the fluoroscopic
      imaging, two transdiscal probes was positioned in the posterior annulus using a
      posterolateral, oblique approach. First, two electrically insulated 17G transdiscal
      introducers was 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 had their
      introducers and electrodes positioned just outside of the disc. This was also be documented
      using fluoroscopy. Investigator attached the electrodes to inactive heater control device
      that provide a similar auditory and visual experience for the patient. Patients were
      therefore remain blinded to actual treatment and physician performing procedure was not
      involved in patient's follow-up. Patients were awake and communicating with the physician
      conducting the procedure and if pain in legs were present and increased during the procedure,
      the heating protocol would be stopped. Following completion of procedure the patient was
      transferred to recovery and monitored for 45 minutes, then discharged home with instructions.
      The patients were followed over a period of 12 months.
    

Eligibility criteria:

        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