Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain - Full Text View

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:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Halyard Health:

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:	April 2015
Estimated Primary Completion Date:	December 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

Halyard Health

More Information

No publications provided


Responsible Party:	Halyard Health
ClinicalTrials.gov Identifier:	NCT01263054 History of Changes
Other Study ID Numbers:	100-10-0001
Study First Received:	November 29, 2010
Last Updated:	November 12, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Halyard Health:


Back Pain Low Back Pain Discogenic Back Pain

Additional relevant MeSH terms:


Back Pain Nervous System Diseases Neurologic Manifestations Pain Signs and Symptoms

ClinicalTrials.gov processed this record on February 25, 2015

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