Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Disco… (NCT01263054) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
United States67 participantsStarted 2010-12
Plain-language 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).
Who can participate
Age range21 Years
SexALL
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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 …
What they're measuring
1
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.