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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TransDiscal System | Experimental | Kimberly-Clark TransDiscal System in addition to standard medical management |
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| Medical Management | Other | Standard medical management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransDiscal System | Device | Surgical Procedure using the TransDiscal System to perform disc biacuplasty. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Curd, MS | Halyard Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States | ||
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | TransDiscal System | Kimberly-Clark TransDiscal System in addition to standard medical management TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty. |
| FG001 | Medical Management |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Medical Management | Other | Standard medical management, physical therapy, and lifestyle changes. |
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| 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. | 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. | 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. | 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. | 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. | Baseline and 6 Months |
| Compass Research |
| Orlando |
| Florida |
| 32806 |
| United States |
| Millennium Pain Center | Bloomington | Illinois | 61701 | United States |
| Metro Orthopedics & Sports Therapy | Silver Spring | Maryland | 20910 | United States |
| PainCare | Linwood | New Jersey | 08221 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| JPS Orthopedic & Sports Medicine | Arlington | Texas | 76018 | United States |
| Center for Pain Relief, University of Washington | Seattle | Washington | 98105 | United States |
Standard medical management
Medical Management: Standard medical management, physical therapy, and lifestyle changes.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TransDiscal System | Kimberly-Clark TransDiscal System in addition to standard medical management TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty. |
| BG001 | Medical Management | Standard medical management Medical Management: Standard medical management, physical therapy, and lifestyle changes. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| 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. | Posted | Number | percentage of study group | Baseline and 6 months |
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| 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. | Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| 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. | Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| 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. | Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| 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. | Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data. | Posted | Mean | Standard Error | units on a scale | Baseline and 6 months |
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| 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. | Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 Months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TransDiscal System | Kimberly-Clark TransDiscal System in addition to standard medical management TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty. | 3 | 29 | 24 | 29 | ||
| EG001 | Medical Management | Standard medical management Medical Management: Standard medical management, physical therapy, and lifestyle changes. | 1 | 34 | 23 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pancreatitis | Gastrointestinal disorders |
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| abdominal pain upper | Gastrointestinal disorders |
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| completed suicide | Psychiatric disorders |
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| iliac artery occlusion | Vascular disorders |
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| chest pain | General disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders |
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| discomfort | General disorders |
| |||
| fatigue | General disorders |
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| inflammation | General disorders |
| |||
| pain | General disorders |
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| swelling | General disorders |
| |||
| seasonal allergy | Immune system disorders |
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| diverticulitis | Infections and infestations |
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| nasopharyngitis | Infections and infestations |
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| sinusitis | Infections and infestations |
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| upper respiratory tract infection | Infections and infestations |
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| herpes zoster | Infections and infestations |
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| influenza | Infections and infestations |
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| foot fracture | Injury, poisoning and procedural complications |
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| accident | Injury, poisoning and procedural complications |
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| fall | Injury, poisoning and procedural complications |
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| head injury | Injury, poisoning and procedural complications |
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| road traffic accident | Injury, poisoning and procedural complications |
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| hypokalemia | Metabolism and nutrition disorders |
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| arthralgia | Musculoskeletal and connective tissue disorders |
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| osteoarthritis | Musculoskeletal and connective tissue disorders |
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| sacroiliitis | Musculoskeletal and connective tissue disorders |
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| muscle spasms | Musculoskeletal and connective tissue disorders |
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| foot deformity | Musculoskeletal and connective tissue disorders |
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| intervertebral disc displacement | Musculoskeletal and connective tissue disorders |
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| back pain | Musculoskeletal and connective tissue disorders |
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| musculoskeletal pain | Musculoskeletal and connective tissue disorders |
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| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders |
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| neck pain | Musculoskeletal and connective tissue disorders |
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| pain in extremity | Musculoskeletal and connective tissue disorders |
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| plantar fasciitis | Musculoskeletal and connective tissue disorders |
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| bunion | Musculoskeletal and connective tissue disorders |
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| bursitis | Musculoskeletal and connective tissue disorders |
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| headache | Nervous system disorders |
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| migraine | Nervous system disorders |
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| dizziness postural | Nervous system disorders |
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| parathesia | Nervous system disorders |
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| sciatica | Nervous system disorders |
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| depression | Psychiatric disorders |
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| insomnia | Psychiatric disorders |
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| loss of bladder sensation | Renal and urinary disorders |
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| pollakiuria | Renal and urinary disorders |
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| thrombophlebitis | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lavigne | Halyard Health, Inc. | 508-837-1427 | mark.lavigne@hyh.com |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| D026741 | Physical Therapy Modalities |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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