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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
Standard medical management, physical therapy, and lifestyle changes.
George Washington University Hospital
Washington D.C., District of Columbia, United States
Compass Research
Orlando, Florida, United States
Millennium Pain Center
Bloomington, Illinois, United States
Metro Orthopedics & Sports Therapy
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
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
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
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
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.
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Silver Spring, Maryland, United States
PainCare
Linwood, New Jersey, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
JPS Orthopedic & Sports Medicine
Arlington, Texas, United States
Center for Pain Relief, University of Washington
Seattle, Washington, United States
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
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
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