Clinical Trials Logo
  1. Home
  2. Back Pain
  3. NCT01263054

Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain — COLD  

Back Pain Clinical Trial

Official title:
A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain

Clinical 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. 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01263054
Study type Interventional
Source Halyard Health
Contact
Status Completed
Phase N/A
Start date December 2010
Completion date April 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT05982483 - Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain N/A
Completed NCT04744246 - Muscle Activity During Load Carriage in ROTC Cadets N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Active, not recruiting NCT03680846 - Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain N/A
Completed NCT05597189 - Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain N/A
Completed NCT05342181 - Static and Dynamic Core Stability Exercises in Potpartum Back Pain N/A
Completed NCT02955342 - Back and Neck Pain in Adolescence
Not yet recruiting NCT02536274 - "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" N/A
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Recruiting NCT02237105 - The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Terminated NCT02239627 - Epidural Clonidine Versus Corticosteroid for Low Back Pain N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Completed NCT02254694 - The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body N/A
Completed NCT00986180 - NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain Phase 3
Terminated NCT00769626 - Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy Phase 3
Completed NCT00771758 - Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Phase 3
Withdrawn NCT00231374 - Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning N/A
Completed NCT00103675 - Sensor Measurement of Acupuncture Needle Manipulation Phase 1
Completed NCT00454064 - Cognitive-behavioural Treatment of Chronic Back Pain Phase 3