Clinical Trial: Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Prospective, Randomized Study Comparing Conventional, Burst And High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patient

Brief Summary:

Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery. Treatment of this chronic condition by further operation or medical management has a heavy financial impact on health care systems.

Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to be a clinically effective adjunct to medical management. SCS has the advantages of being reversible and less invasive than surgery and may cause fewer issues over time than long-term pharmacological treatments.

Despite variable levels of success in the literature, approximately 30-55% of the patients treated with traditional SCS for neuropathic pain disorders will not receive adequate long term pain relief. Therefore, technical SCS system refinements, as well as new techniques have emerged.

Two new stimulation waveforms based on traditional SCS technology have appeared to further optimize the outcome for specific painful conditions;

  • Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz per burst and pulse width and interspike intervals of 1 ms.
  • High-frequency stimulation (from 1 to 10 kHz) mode.

Several studies have demonstrated the potential interest of these 2 new waveforms to treat FBSS patients compared to traditional SCS.

The Precision Spectra™ system allows MultiWave Technology by offering a broad spec

Detailed Summary:
Sponsor: Poitiers University Hospital

Current Primary Outcome: Change from baseline global Pain Visual Analogic Scale (VAS) to 1 month after each waveform stimulation [ Time Frame: 1 month after stimulation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Leg and back Pain Visual Analogic Scale (VAS) [ Time Frame: Through study completion, an average of 1 year ]
  • Oswestry Disability Index (ODI) [ Time Frame: Through study completion, an average of 1 year ]
  • EQ-5D [ Time Frame: Through study completion, an average of 1 year ]
  • Paraesthesia perception VAS [ Time Frame: Through study completion, an average of 1 year ]
  • Adverse Events/Serious Adverse Events [ Time Frame: Through study completion, an average of 1 year ]


Original Secondary Outcome: Same as current

Information By: Poitiers University Hospital

Dates:
Date Received: December 13, 2016
Date Started: January 2017
Date Completion:
Last Updated: January 5, 2017
Last Verified: January 2017