Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase

Brief summary (from the registry)

Traditionally, pain relief through spinal cord stimulation has been associated with the appearance of paresthesia in the affected area. Several parameters are set to maximize the overexposure zone, such as frequency,and pulse width. Although this technique has improved pain in many patients, paresthesia itself can be uncomfortable. Traditionally, the occurrence of paresthesias has been considered to be a predictor of success in pain elimination, while the non-occurrence of paresthesias would indicate failure. So far, few studies have reported pain relief below the threshold of onset of paresthesia. Some clinical trials for pathologies other than the one considered in this study have achieved relief below the threshold by reducing the amplitude of the stimulus. Recently, however, it has been observed in a pilot study that, by increasing the frequency of spinal cord stimulation to 1 kilohertz, it is possible to significantly improve pain relief compared to less frequent conventional stimulation based on the occurrence of paresthesias. A recent review by the Cochrane Library concluded that conventional spinal cord stimulation for pain relief of Failed Back Surgery Syndrome (or FBSS) requires further clinical studies and better designs to demonstrate its superiority over other therapeutic options. Therefore, although spinal cord stimulation is accepted by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), new techniques are being introduced that offer better results in terms of pain relief. Among these techniques, there is the high frequency mode, which allows avoiding the annoying sensation of paresthesia that substitutes pain with the conventional technique. In order to provide greater rigour and scientific quality, the present study is proposed, in which the conventional spinal cord stimulation (CME) technique (control branch or CME) is compared with paresthesias and a standard frequency (60 hertz) with a high frequency (1000 hertz) EVOLV…

Study details

Official title

Randomized, Single-blind, Multicenter, Crossover, Controlled Clinical Trial to Compare Difference on the Visual Analogue Scale With Two Modes of Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase

Conditions

• Laminectomy
• Post-laminectomy Syndrome
• Spinal Cord Syndrome
• Failed Back Surgery Syndrome

Interventions

• Device: spinal cord stimulation conventional
• Device: spinal cord stimulation experimental

Sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Collaborators

Instituto de Investigación Biomédica de Salamanca

Start date

2018-11-20

Primary completion

2020-07-01

Sex

All

Age range

from 18 Years

Results posted

Yes, on ClinicalTrials.gov

Countries

Spain

Total sites listed

2

Eligibility criteria