Status:
COMPLETED
Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
Lead Sponsor:
Baylis Medical Company
Conditions:
Lower Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wil...
Detailed Description
Back Pain
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00750191
Start Date
September 1 2007
End Date
September 1 2012
Last Update
January 8 2014
Active Locations (2)
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1
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
2
Cleveland Clinic Pain Management
Cleveland, Ohio, United States, 44195