Back Pain
Conditions
Keywords
Back Pain, Low Back Pain, Discogenic Back Pain
Brief 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. 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.
Interventions
DEVICETransDiscal System
Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
OTHERMedical Management
Standard medical management, physical therapy, and lifestyle changes.
Sponsors
Halyard Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit | Baseline and 6 months | 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. |
| Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit | Baseline and 6 months | 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. |
| Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score. | 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. |
| Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit | Baseline and 6 months | 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. |
| Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit | Baseline and 6 Months | 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. |
| Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit | Baseline and 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
In this study, 67 subjects were randomized, with 63/67 being treated. Three of the non-treated subjects had exclusion criteria violations, while the fourth subject was not treated for an undisclosed reason. The disposition of subjects in the Participant Flow summary is with respect to the primary outcome.
Participants by arm
| Arm | Count |
|---|---|
| TransDiscal System Kimberly-Clark TransDiscal System in addition to standard medical management
TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty. | 29 |
| Medical Management Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes. | 34 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Qualification Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Medical Management | TransDiscal System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 28 Participants | 62 Participants |
| Age, Continuous | 43 years STANDARD_DEVIATION 11 | 41 years STANDARD_DEVIATION 11 | 42 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 34 participants | 29 participants | 63 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 29 | 23 / 34 |
| serious Total, serious adverse events | 3 / 29 | 1 / 34 |
Outcome results
Primary
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.
Time frame: Baseline and 6 months
Population: Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransDiscal System | Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up. | -2.4 units on a scale | Standard Deviation 2.8 |
| Medical Management | Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up. | -0.56 units on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: Baseline and 6 months
Population: Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransDiscal System | Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit | 0.39 units on a scale | Standard Deviation 8 |
| Medical Management | Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit | -0.23 units on a scale | Standard Deviation 4 |
Secondary
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.
Time frame: Baseline and 6 months
Population: Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransDiscal System | Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit | 15 units on a scale | Standard Deviation 42 |
| Medical Management | Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit | 6 units on a scale | Standard Deviation 31 |
Secondary
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.
Time frame: Baseline and 6 Months
Population: Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransDiscal System | Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit | -11 units on a scale | Standard Deviation 17 |
| Medical Management | Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit | 0.22 units on a scale | Standard Deviation 7 |
Secondary
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.
Time frame: Baseline and 6 months
Population: Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransDiscal System | Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit | -1.7 units on a scale | Standard Error 1.6 |
| Medical Management | Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit | 0.3 units on a scale | Standard Error 1.5 |
Secondary
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.
Time frame: Baseline and 6 months
Population: Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransDiscal System | Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit | 18 units on a scale | Standard Deviation 23 |
| Medical Management | Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit | 1.7 units on a scale | Standard Deviation 16 |
Secondary
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TransDiscal System | Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score. | 50 percentage of study group |
| Medical Management | Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score. | 18 percentage of study group |