Back PainCOLDNCT01263054
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
A study testing TransDiscal System and Medical Management in people with Back Pain, run by Halyard Health at 9 sites in United States.
Trial summary
The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- TransDiscal System and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2010to Apr 2015
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years
- Able to understand the informed consent and able to complete outcome measures
- Objective measurements indicating functional impairment related to low back pain
- Stabilized on pain medication regimen for >2 months as defined by a <10% change in dosage
- History of chronic low back pain (>6 months) unresponsive to non-operative care (including physical therapy, anti-inflammatory medication, epidurals, diagnostic facet joint/medial branch blocks, and sacroiliac joint interventions as performed or deemed appropriate by the Investigator)
- Score ≥5 on the Visual Analog Scale (VAS) relating specifically to the average daily low back pain
Show all 9Show fewer
- Back pain more prominent than leg pain which is commonly exacerbated by flexion or bending or prolonged sitting.
- Single level concordant pain reproduction present on lumbar discography in desiccated disc. Magnetic resonance Imaging (MRI) image also supports discography findings. Changes in other disc spaces in the lumbar region do not demonstrate neural compressive lesion.
- Disc height at least 50% of adjacent control disc
Who cannot join
- Evidence of compressive radiculopathy with predominant leg pain
- Evidence of nucleus pulposus herniation or free disc fragments on MRI
- Evidence of > 2 discs dessicated based on MRI or symptomatic involvement of more than one lumbar disc levels.
- Asymptomatic disc bulges > 5 mm at the treatment level.
- Prior lumbar surgery of any kind at the treatment level (micro-discectomies, and/or minimally invasive procedures at other levels that are not excluded)
- Prior spinal fusion below the T10 Level
Show all 26Show fewer
- Symptoms or signs of lumbar canal stenosis at any level
- Evidence of structural abnormality at the lumbar level (except non-symptomatic spondylolysis resulting in spondylolithesis no more than Grade 1 upon flexion and extension)
- Any generalized pain or multifocal pain,conversion or multiple non-anatomical complaints
- Pending or active compensation claim, litigation or disability income remuneration (secondary gain)
- Chronic pain associated with significant psychosocial dysfunction
- Beck's Depression Index (BDI) score >20
- Current pregnancy, recent delivery (within 3 months of consent) or the intent of becoming pregnant during the study period.
- Systemic or localized infection at the anticipated needle entry site (subject may be considered for inclusion once infection is resolved)
- Discitis
- Allergies to any medication to be used in the procedure
- Present symptomatic lumbar spinal fracture
- History of uncontrolled coagulopathy, ongoing coagulation treatment or unexplained or uncontrollable bleeding that is uncorrectable
- Progressive neurological deficits
- Within the preceding 2 years, subject has suffered from active narcotic addiction, substance abuse or alcohol abuse
- Current prescribed opioid medications equivalent to >120 mg of morphine per 24 hours
- Uncontrolled immunosuppression (e.g. Acquired Immune Deficiency Syndrome [AIDS], cancer, diabetes, etc.)
- Body Mass Index (BMI) >32.5 kg/m^2
- Participating in another clinical trial/investigation 30 days prior to signing informed consent
- Negative or indeterminate lumbar discography results as assessed per International Spine Intervention Society (ISIS) guidelines
- Subject unwilling or unable to comply with follow up schedule or protocol requirements.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
JPS Orthopedic & Sports Medicine
Arlington, Texas, 76018
Millennium Pain Center
Bloomington, Illinois, 61701
Cleveland Clinic
Cleveland, Ohio, 44195
PainCare
Linwood, New Jersey, 08221
Compass Research
Orlando, Florida, 32806
Center for Pain Relief, University of Washington
Seattle, Washington, 98105
Metro Orthopedics & Sports Therapy
Silver Spring, Maryland, 20910
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain
The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will be compared against medical management (standard of care).
Read the detailed description
The intervertebral discs serve as joints between the vertebral bodies, providing both structural support and flexibility to the spinal column. Intervertebral discs do not remain structurally intact over a lifetime and degenerate as a natural part of aging. Degenerated discs do not react to stresses and forces the same as healthy discs. When too much stress is applied to a degenerated disc, tears can result. Evidence suggests that when a tear is present, sensory nerve endings can grow into the tear and transmit pain.
The TransDiscal System (TDS) is a medical device that is used in a procedure called Disc Biacuplasty and is currently available in the United States and throughout the world. The TDS enables the back of the disc to be heated to high enough temperatures to ablate the nerves inside that are transmitting pain, while maintaining low enough temperatures to prevent damage to surrounding tissues. The TDS uses two electrodes, located at the ends of two thin probes, which are placed on both sides of the back of the intervertebral disc by inserting them through the skin into the disc using x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature. The study evaluates a modified heating protocol than what is currently in clinical use which should allow for a larger area of the back of the disc to be heated.
- Conditions
- Back Pain
- Being tested
- TransDiscal System, Medical Management
- Keywords
- Back Pain, Low Back Pain, Discogenic Back Pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransDiscal SystemDevice
Also called TransDiscal,disc biacuplasty,disc,ablation,low back pain
Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
Medical ManagementOther
Also called physical therapy, medications,
Standard medical management, physical therapy, and lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| TransDiscal System | Experimental | Kimberly-Clark TransDiscal System in addition to standard medical management Receives: Device: TransDiscal System |
| Medical Management | Other | Standard medical management Receives: Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 months
Secondary outcomes (6)
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 months
Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit
Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 months
Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit
EQ-5d VAS - score range = 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 months
Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit
BDI - score range = 0 - 63. "0" corresponds to "minimal depression" and "63" indicates "severe depression". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 months
Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit
PGIC - score range = 1 - 7. "1" corresponds to "very much improved" and "7" indicates "very much worse" pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 months
Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group.
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2014
- Study completionApr 2015
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.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Curd, MS, Study director, Halyard Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263054
- Sponsor's protocol ID
- 100-10-0001
- Acronym
- COLD
- Status last verified
- Mar 2015
- First submitted
- 29 Nov 2010
- Last updated
- 10 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain
- ClinicalTrials.gov ID
- NCT01263054
- Acronym / sponsor ID
- COLD / 100-10-0001
- Conditions
- Back Pain
- Keywords
- Back Pain, Low Back Pain, Discogenic Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Posted 9 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will be compared against medical management (standard of care).
Detailed description
The intervertebral discs serve as joints between the vertebral bodies, providing both structural support and flexibility to the spinal column. Intervertebral discs do not remain structurally intact over a lifetime and degenerate as a natural part of aging. Degenerated discs do not react to stresses and forces the same as healthy discs. When too much stress is applied to a degenerated disc, tears can result. Evidence suggests that when a tear is present, sensory nerve endings can grow into the tear and transmit pain.
The TransDiscal System (TDS) is a medical device that is used in a procedure called Disc Biacuplasty and is currently available in the United States and throughout the world. The TDS enables the back of the disc to be heated to high enough temperatures to ablate the nerves inside that are transmitting pain, while maintaining low enough temperatures to prevent damage to surrounding tissues. The TDS uses two electrodes, located at the ends of two thin probes, which are placed on both sides of the back of the intervertebral disc by inserting them through the skin into the disc using x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature. The study evaluates a modified heating protocol than what is currently in clinical use which should allow for a larger area of the back of the disc to be heated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TransDiscal System | Experimental | Device: TransDiscal SystemKimberly-Clark TransDiscal System in addition to standard medical management |
| Medical Management | Other | Other: Medical ManagementStandard medical management |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥21 years
- Able to understand the informed consent and able to complete outcome measures
- Objective measurements indicating functional impairment related to low back pain
- Stabilized on pain medication regimen for >2 months as defined by a <10% change in dosage
- History of chronic low back pain (>6 months) unresponsive to non-operative care (including physical therapy, anti-inflammatory medication, epidurals, diagnostic facet joint/medial branch blocks, and sacroiliac joint interventions as performed or deemed appropriate by the Investigator)
Key exclusion criteria (26 listed)
- Evidence of compressive radiculopathy with predominant leg pain
- Evidence of nucleus pulposus herniation or free disc fragments on MRI
- Evidence of > 2 discs dessicated based on MRI or symptomatic involvement of more than one lumbar disc levels.
- Asymptomatic disc bulges > 5 mm at the treatment level.
- Prior lumbar surgery of any kind at the treatment level (micro-discectomies, and/or minimally invasive procedures at other levels that are not excluded)
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 |
|---|---|---|
| TransDiscal SystemAlso: TransDiscal,disc biacuplasty,disc,ablation,low back painSurgical Procedure using the TransDiscal System to perform disc biacuplasty. | Device | TransDiscal System |
| Medical ManagementAlso: physical therapy, medications,Standard medical management, physical therapy, and lifestyle changes. | Other | Medical Management |
Primary outcome
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
Time frame: Baseline and 6 months
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
6 secondary outcomes
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
Time frame: Baseline and 6 months
Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit
Time frame: Baseline and 6 months
Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit
Time frame: Baseline and 6 months
Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit
Time frame: Baseline and 6 months
Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit
Time frame: Baseline and 6 months
Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
Time frame: Baseline and 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Curd, MS study director
Halyard Health, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransDiscal System and Medical Management in people with Back Pain, run by Halyard Health at 9 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 9 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2016). 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?
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2018.