Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome

2014-08-27 03:17:07 | BioPortfolio


The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.

The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Failed Back Surgery Syndrome


Precision Spinal Cord Stimulation, Back Surgery


University of California San Diego
La Jolla
United States




Boston Scientific Corporation

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:07-0400

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Medical and Biotech [MESH] Definitions

A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.

Application of electric current to the spine for treatment of a variety of conditions involving innervation from the spinal cord.

Musculature of the BACK.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.

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