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

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TransDiscal System
Medical Management
Sponsored by
Halyard Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Back Pain, Low Back Pain, Discogenic Back Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • George Washington University Hospital
  • Compass Research
  • Millennium Pain Center
  • Metro Orthopedics & Sports Therapy
  • PainCare
  • Center for Clinical Research
  • Cleveland Clinic
  • JPS Orthopedic & Sports Medicine
  • Center for Pain Relief, University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TransDiscal System

Medical Management

Arm Description

Kimberly-Clark TransDiscal System in addition to standard medical management

Standard medical management

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 29, 2010
Last Updated
June 12, 2018
Sponsor
Halyard Health
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1. Study Identification

Unique Protocol Identification Number
NCT01263054
Brief Title
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
Acronym
COLD
Official Title
A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halyard Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Back Pain, Low Back Pain, Discogenic Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TransDiscal System
Arm Type
Experimental
Arm Description
Kimberly-Clark TransDiscal System in addition to standard medical management
Arm Title
Medical Management
Arm Type
Other
Arm Description
Standard medical management
Intervention Type
Device
Intervention Name(s)
TransDiscal System
Other Intervention Name(s)
TransDiscal,disc biacuplasty,disc,ablation,low back pain
Intervention Description
Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
Intervention Type
Other
Intervention Name(s)
Medical Management
Other Intervention Name(s)
physical therapy, medications,
Intervention Description
Standard medical management, physical therapy, and lifestyle changes.
Primary Outcome Measure Information:
Title
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
Description
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
Title
Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit
Description
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
Title
Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit
Description
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
Title
Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit
Description
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.
Time Frame
Baseline and 6 months
Title
Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit
Description
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
Title
Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Curd, MS
Organizational Affiliation
Halyard Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Metro Orthopedics & Sports Therapy
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
PainCare
City
Linwood
State/Province
New Jersey
ZIP/Postal Code
08221
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
JPS Orthopedic & Sports Medicine
City
Arlington
State/Province
Texas
ZIP/Postal Code
76018
Country
United States
Facility Name
Center for Pain Relief, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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

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