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

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

Summary

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

Conditions

Failed Back Surgery Syndrome

Intervention

Precision Spinal Cord Stimulation, Back Surgery

Location

University of California San Diego
La Jolla
California
United States
92037

Status

Recruiting

Source

Boston Scientific Corporation

Results (where available)

View Results

Links

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

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Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.

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PubMed Articles [17563 Associated PubMed Articles listed on BioPortfolio]

Long-Term Outcome of Spinal Cord Stimulation in Failed Back Surgery Syndrome: 20 Years of Experience With 224 Consecutive Patients.

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Is Spinal Cord Stimulation a Viable Therapy for Failed Back Surgery Syndrome? Yes!: Better Than the Alternatives for Failed Back Surgery Syndrome.

Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study.

Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously randomized 52 FBSS patients to be treated with spin...

Integration of Spinal Cord Stimulation in Treatment of Failed Back Surgery Syndrome.

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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