Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

NCT ID: NCT00750191

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-09-30

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 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.

Detailed Description

Back Pain

Conditions

Lower Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

The Transdiscal Radiofrequency Annuloplasty

Intervention Type: DEVICE

Adjustment in dosage form, frequency and or duration.

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.

Group Type: PLACEBO_COMPARATOR

The Transdiscal Radiofrequency Annuloplasty

Intervention Type: DEVICE

interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A

Interventions

The Transdiscal Radiofrequency Annuloplasty

Adjustment in dosage form, frequency and or duration.

Intervention Type: DEVICE

The Transdiscal Radiofrequency Annuloplasty

interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A

Intervention Type: DEVICE

Other Intervention Names

Intradiscal Biacuplasty Active Comparator; Sham: Placebo Comparator

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylis Medical Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonardo Kapural, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical Research

Bruce Vrooman, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Cleveland Clinic Pain Management

Cleveland, Ohio, United States

Countries

United States

References

Kapural L, Vrooman B, Sarwar S, Krizanac-Bengez L, Rauck R, Gilmore C, North J, Girgis G, Mekhail N. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013 Mar;14(3):362-73. doi: 10.1111/pme.12023. Epub 2012 Dec 28.

Reference Type: DERIVED

PMID: 23279658 (View on PubMed)

Other Identifiers

IRB 07-594

Identifier Type: -

Identifier Source: secondary_id

IRB 07-594

Identifier Type: -

Identifier Source: org_study_id