Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study).

Objective: This paper presents the protocol of the EVIDENCE study, a multicenter multinational randomized controlled trial to assess the effectiveness and cost-effectiveness of spinal cord stimulation (SCS) with rechargeable pulse generator versus re-operation through 36-month follow-up in patients with failed back surgery syndrome.

Study Design: Study subjects have neuropathic radicular leg pain exceeding or equaling any low back pain and meet specified entry criteria. One-to-one randomization is stratified by site and by one or more prior lumbosacral operations.

The usefulness property of biorobotic sensorimotor models: A natural source of prosthetic designs.

This commentary addresses an additional feature of biorobotic modeling: usefulness in prosthetic design. By implementing structurally and behaviorally accurate models as prosthetics, biologically accurate restoration can be approximated. This has potential to reestablish important peripheral elements of the sensorimotor control system, including limb biomechanics, proprioception, and vision.

A biorobotic structural model of the mammalian muscle spindle primary afferent response.

A biorobotic model of the mammalian muscle spindle Ia response was implemented in precision hardware. We derived engineering specifications from displacement, receptor potential, and Ia data in the muscle spindle literature, allowing reproduction of muscle spindle behavior directly in the robot's hardware; a linear actuator replicated intrafusal contractile behavior, a cantilever-based transducer reproduced sensory membrane depolarization, and a voltage-controlled oscillator encoded strain into a frequency signal. Aspects of muscle spindle behavior not intrinsic to the physical design were added in control software using an adaptation of Schaafsma's mathematical model.