Lower Back PainPhase 1NCT00750191
Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty
A Phase 1 study testing The Transdiscal Radiofrequency Annuloplasty in people with Lower Back Pain, run by Baylis Medical Company at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- The Transdiscal Radiofrequency Annuloplasty
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Sep 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Pain Management
Cleveland, Ohio, 44195
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
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.
Read the detailed description
Back Pain
- Conditions
- Lower Back Pain
- Being tested
- The Transdiscal Radiofrequency Annuloplasty
- Keywords
- Lower Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Transdiscal Radiofrequency AnnuloplastyDevice
Also called Intradiscal Biacuplasty Active Comparator
Adjustment in dosage form, frequency and or duration.
The Transdiscal Radiofrequency AnnuloplastyDevice
Also called Sham: Placebo Comparator
interventions include adjustment to dosage form,frequency,duration or switching to treatment arm A
| Study group | Role | What they receive |
|---|---|---|
| Intradiscal Biacuplasty | Active comparator | 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. Receives: Device: The Transdiscal Radiofrequency Annuloplasty |
| Sham | Placebo comparator | 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. Receives: Device: The Transdiscal Radiofrequency Annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (2)
Pain
Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)
Measured: 6 months
Disability
Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylis Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonardo Kapural, MD, Principal investigator, Center for Clinical ResearchBruce Vrooman, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750191
- Sponsor's protocol ID
- IRB 07-594
- Other IDs
- IRB 07-594
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2008
- Last updated
- 8 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23279658
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty for Treatment of Discogenic Lower Back Pain
- ClinicalTrials.gov ID
- NCT00750191
- Acronym / sponsor ID
- IRB 07-594
- Conditions
- Lower Back Pain
- Keywords
- Lower Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Baylis Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 8 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradiscal Biacuplasty | Active comparator | Device: The Transdiscal Radiofrequency AnnuloplastyOn 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 | Placebo comparator | Device: The Transdiscal Radiofrequency AnnuloplastySham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The inclusion criteria will be as follows:
Key exclusion criteria (26 listed)
- The exclusion criteria are :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Transdiscal Radiofrequency AnnuloplastyAlso: Intradiscal Biacuplasty Active ComparatorAdjustment in dosage form, frequency and or duration. | Device | Intradiscal Biacuplasty |
| The Transdiscal Radiofrequency AnnuloplastyAlso: Sham: Placebo Comparatorinterventions include adjustment to dosage form,frequency,duration or switching to treatment arm A | Device | Sham |
Primary outcome
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).
2 secondary outcomes
Pain
Time frame: 6 months
Disability
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23279658Kapural 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Kapural, MD principal investigator
Center for Clinical Research
Bruce Vrooman, M.D. principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The Transdiscal Radiofrequency Annuloplasty in people with Lower Back Pain, run by Baylis Medical Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.