Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
| Status: | Completed |
|---|---|
| Conditions: | Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | September 2007 |
| End Date: | September 2012 |
| Contact: | Sheryar Sarwar, M.D. |
| Email: | SARWARS@ccf.org |
| Phone: | 216-636-0103 |
A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
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
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
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