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

CompletedNot applicableNCT01263054
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain
Conditions
Interventions
  • Device: TransDiscal System
  • Other: Medical Management
Sponsor
Halyard Health
Start date
2010-12
Primary completion
2014-12
Sex
All
Age range
from 21 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
9

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 t…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01263054