Low Back PainPhase 4TD-RCT-002NCT00749554
Trial of Disc Biacuplasty to Treat Chronic Discogenic Low Back Pain
A Phase 4 study testing Disc biacuplasty in people with Low Back Pain, run by Baylis Medical Company at 1 site in Canada.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Disc biacuplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Age >18 years
- Able to understand the informed consent and baseline/follow-up questionnaires
- Chronic low back pain > leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment
- No clinical evidence of SI joint mediated pain
- Concordant pain reproduced on provocative discography at an intensity of >6/10 at low pressure (<50 psi) at not more than 2 discs and a negative response at an adjacent control disc
- Preservation of at least 50% height of the symptomatic disc(s)
Who cannot join
- Active radicular pain
- Nucleus pulposus herniation > 5 mm, extrusion or sequestration on MRI
- Spondylolithesis at the symptomatic level
- Prior surgery at the symptomatic level
- Concomitant cervical or thoracic pain >2/10 (VAS) in severity
- Other chronic pain conditions (i.e. Fibromyalgia Syndrome)
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- Immunosuppression (i.e. Cancer, AIDS, Rheumatoid arthritis)
- Third-party (WSIB, litigation or insurance) involvement
- Psychological issues impeding recovery by history, examination and/or a Beck Depression Inventory score of >20
- Systemic or localized infection (at the anticipated needle entry sites)
- BMI > 35 (Obesity)
- Substance or opioid abuse
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Disc biacuplasty, Sham biacuplasty
- Keywords
- Cooled Radiofrequency, Disc biacuplasty, TransDiscal system, Discogenic 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.
Disc biacuplastyDevice
Also called TransDiscal, Cooled Radiofrequency, Intradiscal biacuplasty
The lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C).
Sham biacuplastyDevice
Probes not inserted into disc, no RF electricity applied.
| Study group | Role | What they receive |
|---|---|---|
| Disc biacuplasty | Active comparator | Not described Receives: Device: Disc biacuplasty |
| Sham treatment. | Placebo comparator | Not described Receives: Device: Sham biacuplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
Measured: 12 months
Secondary outcomes (5)
Oswestry Disability Index
Measured: 12 months
Assessment of Quality of Life
Measured: 12 months
SF-36 for physical functioning
Measured: 12 months
Reduction in Medication Intake
Measured: 12 months
Patient satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2010 (estimated)
Why it stopped: Primary Investigator Retired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylis Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Investigators
- Robert S Burnham, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749554
- Sponsor's protocol ID
- TD-RCT-Burnham
- Acronym
- TD-RCT-002
- Status last verified
- Jun 2010
- First submitted
- 8 Sep 2008
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kapural L, Ng A, Dalton J, Mascha E, Kapural M, de la Garza M, Mekhail N. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: results of a six-month follow-up. Pain Med. 2008 Jan-Feb;9(1):60-7. doi: 10.1111/j.1526-4637.2007.00407.x.
PubMed 18254768Kapural L. Intervertebral disk cooled bipolar radiofrequency (intradiskal biacuplasty) for the treatment of lumbar diskogenic pain: a 12-month follow-up of the pilot study. Pain Med. 2008 May-Jun;9(4):407-8. doi: 10.1111/j.1526-4637.2008.00464.x. No abstract available.
PubMed 18489632
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded Randomised Placebo-Controlled Trial of TransDiscal Biacuplasty for Patients With Mechanical Low Back Pain of Disc Origin
- ClinicalTrials.gov ID
- NCT00749554
- Acronym / sponsor ID
- TD-RCT-002 / TD-RCT-Burnham
- Conditions
- Low Back Pain
- Keywords
- Cooled Radiofrequency, Disc biacuplasty, TransDiscal system, Discogenic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary Investigator Retired.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylis Medical CompanyIndustry (pharma, biotech, devices)
- Collaborators
- University of Alberta
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (estimated)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to evaluate the effectiveness of Disc Biacuplasty in relieving pain, reducing medication intake and improving function, satisfaction and quality of life of patients with chronic mechanical discogenic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disc biacuplasty | Active comparator | Device: Disc biacuplasty |
| Sham treatment. | Placebo comparator | Device: Sham biacuplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Able to understand the informed consent and baseline/follow-up questionnaires
- Chronic low back pain > leg pain for longer than 6 months, unresponsive to comprehensive non-operative treatment
- No clinical evidence of SI joint mediated pain
- Concordant pain reproduced on provocative discography at an intensity of >6/10 at low pressure (<50 psi) at not more than 2 discs and a negative response at an adjacent control disc
Key exclusion criteria (13 listed)
- Active radicular pain
- Nucleus pulposus herniation > 5 mm, extrusion or sequestration on MRI
- Spondylolithesis at the symptomatic level
- Prior surgery at the symptomatic level
- Concomitant cervical or thoracic pain >2/10 (VAS) in severity
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 |
|---|---|---|
| Disc biacuplastyAlso: TransDiscal, Cooled Radiofrequency, Intradiscal biacuplastyThe lesion duration will be 15 minutes with a ramp rate of 2°C per minute and a peak set temperature of 45°C (Temperature in posterior annulus of disc reaches 65°C). | Device | Disc biacuplasty |
| Sham biacuplastyProbes not inserted into disc, no RF electricity applied. | Device | Sham treatment. |
Primary outcome
Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS).
Time frame: 12 months
5 secondary outcomes
Oswestry Disability Index
Time frame: 12 months
Assessment of Quality of Life
Time frame: 12 months
SF-36 for physical functioning
Time frame: 12 months
Reduction in Medication Intake
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Primary Investigator Retired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
- Background: PubMed 18254768Kapural L, Ng A, Dalton J, Mascha E, Kapural M, de la Garza M, Mekhail N. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: results of a six-month follow-up. Pain Med. 2008 Jan-Feb;9(1):60-7. doi: 10.1111/j.1526-4637.2007.00407.x.
- Background: PubMed 18489632Kapural L. Intervertebral disk cooled bipolar radiofrequency (intradiskal biacuplasty) for the treatment of lumbar diskogenic pain: a 12-month follow-up of the pilot study. Pain Med. 2008 May-Jun;9(4):407-8. doi: 10.1111/j.1526-4637.2008.00464.x. No abstract available.
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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.
Robert S Burnham, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Disc biacuplasty in people with Low Back Pain, run by Baylis Medical Company at 1 site in Canada.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Primary Investigator Retired.). Results are not available in the source record.
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?
Duration (months) of greater than 50% pain relief compared to pre-procedure baseline on the visual analogue scale (VAS). (time frame: 12 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 NCT00749554, which also lists 2 linked publications.
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 7 Jun 2010.