Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

Lower Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750191
• Other study ID #: IRB 07-594
• Secondary ID: IRB 07-594
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2008
• Last updated: November 20, 2013
• Start date: September 2007
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: Baylis Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Back Pain

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Device:
• The Transdiscal Radiofrequency Annuloplasty
Adjustment in dosage form, frequency and or duration.
• The Transdiscal Radiofrequency Annuloplasty
interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A

Locations

Country	Name	City	State
United States	Cleveland Clinic Pain Management	Cleveland	Ohio
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Baylis Medical Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opioid Usage	Patient reported Opioid usage (converted to morphine equivalents)	6 months	No
Primary	Physical Function	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	No
Secondary	Pain	Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)	6 months	No
Secondary	Disability	Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)	6 months	No