TREATMENT OF DISCOGENIC LOW BACK PAIN WITH INTRADISCAL ELECTROTHERMAL THERAPY [IDET], A MINIMALLY INVASIVE, LOW COST ALTERNATIVE TO OPEN SURGERY- A PROSPECTIVE 24-MONTH OUTCOMES STUDY IN 50 CONSECUTIVE PATIENTS

Author(s)

Jon E Block, PhD, Director1, Roberto Assietti, MD, Neurosurgeon, Chief of Day Surgery2, Mario Morosi, MD, Neurosurgeon2, Luigi Meani, MD, Neurosurgeon2, Margarita Schultz, BscPhm, MBA, President3, Barbara Rohan, RN, MEd-HAdm, Vice President, Global Government Affairs41Jon E Block PhD Inc, San Francisco, CA, USA; 2 Ospedale Fatebenefratelli e Oftalmico, Milano, Italy; 3 Pharmaccess Inc, Westmount, QC, Canada; 4 Smith&Nephew Inc, Memphis, TN, USA

OBJECTIVES: Pathologic deterioration of intervertebral discs, characterized by annular tears, can cause severe, unremitting low back pain [LBP] resulting in loss of function and quality of life for millions of individuals worldwide. Patients experiencing severe back symptoms beyond six months have poor prognosis for recovery with conservative management alone. Open surgical intervention such as spinal fusion and artificial disc replacement are being utilized with escalating frequency, however costs and risks are high. Performed in the outpatient setting, intradiscal electrothermal therapy [IDET] is minimally invasive, less costly alternative to surgery for patients nonresponsive to conservative care. This study prospectively evaluated effectiveness of IDET in 50 consecutive adult patients refractory to conservative care of at least six months duration. METHODS: Using MRI and discography to establish internal disc disruption, 50 patients with lumbar discogenic pain were identified, underwent IDET treatment and followed for 24 months. Back pain severity (11-point numeric scale) and back function (Oswestry disability index [ODI]) were evaluated pre-treatment, 12 and 24 months post-procedure. Clinical success defined as lack of follow-up surgery, ≥2-point pain, and ≥15-point ODI improvement. RESULTS: Average 68% and 66% improvements in pain and ODI, respectively, between pre-treatment and 24 months (p<0.0001 for both comparisons). Global clinical success rate was 78% (39/50). No complications occurred during IDET procedure. No post-procedural adverse events such as infections or neurological sequelae reported. CONCLUSIONS: The significant and robust clinical improvements in function through 24 months and 78% global success rate achieved in this study compare favorably with previously published results for IDET using similar patient selection criteria. Careful patient selection based on discography and imaging may improve outcomes. Risk of procedure-related adverse events is low. IDET offers a safe, low-cost treatment alternative with demonstrated durable, long-term clinical benefits in the continuum of care of patients with discogenic LBP.

Conference/Value in Health Info

2008-11, ISPOR Europe 2008, Athens, Greece

Value in Health, Vol. 11, No. 6 (November 2008)

Code

PHC1

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology

Disease

Surgery

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