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Completed

NCT Number: NCT00750191

Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

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.

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Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Center for Clinical Research, Winston-Salem, North Carolina, United States

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About this study

Back Pain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Transdiscal Radiofrequency Annuloplasty

Device

Adjustment in dosage form, frequency and or duration.

Other names: Intradiscal Biacuplasty Active Comparator

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. Disability

    Time frame: 6 months

    Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)

Other outcomes

  1. Opioid Usage

    Time frame: 6 months

    Patient reported Opioid usage (converted to morphine equivalents)

Sponsors and collaborators

Lead sponsor

Baylis Medical Company

Industry

Registry information

Official study title

A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2008
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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