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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kimberly-Clark Corporation
ClinicalTrials.gov Identifier:
NCT01263054
First received: November 29, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Back Pain
Device: TransDiscal System
Other: Medical Management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain

Resource links provided by NLM:


Further study details as provided by Kimberly-Clark Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TransDiscal procedure
Kimberly-Clark TransDiscal Procedure in addition to standard medical management
Device: TransDiscal System
Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
Other Name: TransDiscal,disc biacuplasty,disc,ablation,low back pain
Medical Management
Standard medical management
Other: Medical Management
Standard medical management, physical therapy, and lifestyle changes.
Other Name: physical therapy, medications,

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263054

Locations
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
United States, Illinois
Millennium Pain Center
Bloomington, Illinois, United States, 61701
United States, Maryland
Metro Orthopedics & Sports Therapy
Silver Spring, Maryland, United States, 20910
United States, New Jersey
PainCare
Linwood, New Jersey, United States, 08221
United States, North Carolina
Center for Clinical Research
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
JPS Orthopedic & Sports Medicine
Arlington, Texas, United States, 76018
United States, Washington
Center for Pain Relief, University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Kimberly-Clark Corporation
  More Information

No publications provided

Responsible Party: Kimberly-Clark Corporation
ClinicalTrials.gov Identifier: NCT01263054     History of Changes
Other Study ID Numbers: 100-10-0001
Study First Received: November 29, 2010
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kimberly-Clark Corporation:
Back Pain
Low Back Pain
Discogenic Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014