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

NCT01263054 | Completed Results

• 1 other identifier: 100-10-0001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 9

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).

Conditions

Back Pain

Keywords

Back Pain; Low Back Pain; Discogenic Back Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (6)

• Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.

  Baseline and 6 months

• Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit

  Baseline and 6 months

• Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit

  Baseline and 6 months

• Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit

  Baseline and 6 months

• Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit

  Baseline and 6 months

Study Arms (2)

TransDiscal System

EXPERIMENTAL

Kimberly-Clark TransDiscal System in addition to standard medical management

Device: TransDiscal System

Medical Management

OTHER

Standard medical management

Other: Medical Management

Interventions

TransDiscal System DEVICE

Surgical Procedure using the TransDiscal System to perform disc biacuplasty.

Also known as: TransDiscal,disc biacuplasty,disc,ablation,low back pain

TransDiscal System

Medical Management OTHER

Standard medical management, physical therapy, and lifestyle changes.

Also known as: physical therapy, medications,

Medical Management

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Discitis
• Allergies to any medication to be used in the procedure

Sponsors & Collaborators

• Halyard Health: lead

Study Sites (9)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Metro Orthopedics & Sports Therapy

Silver Spring, Maryland, 20910, United States

Location

PainCare

Linwood, New Jersey, 08221, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

JPS Orthopedic & Sports Medicine

Arlington, Texas, 76018, United States

Location

Center for Pain Relief, University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Practice Management, Medical; Physical Therapy Modalities; Dosage Forms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Therapeutics; Rehabilitation; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Mark Lavigne
• Organization: Halyard Health, Inc.

mark.lavigne@hyh.com

508-837-1427

Study Officials

• David Curd, MS

  Halyard Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 20, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: July 10, 2018
• Results First Posted: March 9, 2016

Record last verified: 2015-03

Locations

US (9)