- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750191
Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Pain Management
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intradiscal Biacuplasty
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. |
Adjustment in dosage form, frequency and or duration.
Other Names:
interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
Other Names:
|
Placebo Comparator: Sham
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. |
Adjustment in dosage form, frequency and or duration.
Other Names:
interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function
Time Frame: 6 months
|
Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component. Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome). |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 6 months
|
Pain level as measured by the Numerical Rating Scale.
Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)
|
6 months
|
Disability
Time Frame: 6 months
|
Disability as measured by the Oswestry Disability Index.
Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Usage
Time Frame: 6 months
|
Patient reported Opioid usage (converted to morphine equivalents)
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leonardo Kapural, MD, Center for Clinical Research
- Principal Investigator: Bruce Vrooman, M.D., The Cleveland Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 07-594
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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