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Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
The Transdiscal Radiofrequency Annuloplasty
The Transdiscal Radiofrequency Annuloplasty
Sponsored by
Baylis Medical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Lower Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Center for Clinical Research
  • Cleveland Clinic Pain Management

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intradiscal Biacuplasty

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain
Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)
Disability
Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)

Full Information

First Posted
September 9, 2008
Last Updated
November 20, 2013
Sponsor
Baylis Medical Company
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1. Study Identification

Unique Protocol Identification Number
NCT00750191
Brief Title
Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
Official Title
A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylis Medical Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
Lower Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intradiscal Biacuplasty
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The Transdiscal Radiofrequency Annuloplasty
Other Intervention Name(s)
Intradiscal Biacuplasty Active Comparator
Intervention Description
Adjustment in dosage form, frequency and or duration.
Intervention Type
Device
Intervention Name(s)
The Transdiscal Radiofrequency Annuloplasty
Other Intervention Name(s)
Sham: Placebo Comparator
Intervention Description
interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
Primary Outcome Measure Information:
Title
Physical Function
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain
Description
Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)
Time Frame
6 months
Title
Disability
Description
Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Opioid Usage
Description
Patient reported Opioid usage (converted to morphine equivalents)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Kapural, MD
Organizational Affiliation
Center for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Vrooman, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Pain Management
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23279658
Citation
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.
Results Reference
derived

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Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty

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