Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
Lower Back Pain
About this trial
This is an interventional treatment trial for Lower Back Pain focused on measuring Lower Back Pain
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
Sites / Locations
- The Center for Clinical Research
- Cleveland Clinic Pain Management
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intradiscal Biacuplasty
Sham
On the day of the procedure, patients were given midazolam for relaxation and, if needed, fentanyl IV during the procedure. For treatment subjects, two TransDiscal probes were positioned under fluoroscopic guidance in the posterior annulus of the intervertebral disc. The probes were attached to the Radiofrequency generator and Radiofrequency energy was delivered. Placement of the probes within the disc annulus was confirmed using oblique, lateral, and anterior-posterior fluoroscopic images. Following completion of procedure the patient was transferred to recovery and monitored for 45 minutes then discharged home with instructions. It was expected that the patient limit their activities during the first week after the procedure.
Sham procedures mimicked active treatment procedures, except that the probes were positioned just outside of the disc and no radiofrequency energy was delivered through the electrodes. Thus, sham patients were provided similar tactile, auditory and visual experiences as treatment patients, without receiving the active RF treatment. Following completion of procedure the patient was transferred to recovery and monitored for 45 minutes then discharged home with instructions. It was expected that the patient limit their activities during the first week after the 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.