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

This study is currently recruiting participants.
Verified January 2014 by Kimberly-Clark Corporation
Sponsor:
Information provided by (Responsible Party):
Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:
NCT01263054
First received: November 29, 2010
Last updated: January 22, 2014
Last verified: January 2014

November 29, 2010
January 22, 2014
December 2010
June 2014   (final data collection date for primary outcome measure)
Change in average daily pain Visual Analog Scale (VAS) score between Screening and Follow up. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Change in average daily pain Visual Analog Scale (VAS) score between Screening and Follow up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01263054 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with greater than 2 points decrease or 30% drop in average daily pain related VAS score. [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of Short Form 36 (SF-36) from screening to 6 month follow up visit [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of EuroQuol 5d (EQ-5d) between screening and 6 month follow up visit [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of Beck's Depression Inventory (BDI) between screening and 6 month follow up visit [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean change in score of Oswestry Disability Index (ODI) between screening and 6 month follow up visit [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Proportion of subjects with greater than 2 points decrease or 30% drop in average daily pain related VAS score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of Short Form 36 (SF-36) from screening to 6 month follow up visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of Oswestry Disability Index (ODI) between screening and 6 month follow up visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of EuroQuol 5d (EQ-5d) between screening and 6 month follow up visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of Beck's Depression Inventory (BDI) between screening and 6 month follow up visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in score of Patient Global Impression of Change (PGIC) between screening and 6 month follow up visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Back Pain
  • Device: TransDiscal System
    Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
    Other Name: TransDiscal,disc biacuplasty,disc,ablation,low back pain
  • Other: Medical Management
    Standard medical management, physical therapy, and lifestyle changes.
    Other Name: physical therapy, medications,
  • Experimental: TransDiscal procedure
    Kimberly-Clark TransDiscal Procedure in addition to standard medical management
    Intervention: Device: TransDiscal System
  • Medical Management
    Standard medical management
    Intervention: Other: Medical Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Not Provided
United States
 
NCT01263054
100-10-0001
No
Kimberly-Clark Corporation
Kimberly-Clark Corporation
Not Provided
Not Provided
Kimberly-Clark Corporation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP