Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS). The lack of a validated technique for back pain relief has prompted the development of newer devices, including leads with increased number of contacts (up to 16) and various geometric arrangements, the objective of which is to cover a larger area while attempting to extend, steer, or focus the electric field of the stimulation within the spinal cord regions. This led companies to design a new generation of multicolumn surgical leads that allow the activation of longitudinal and transverse electric fields (multicolumn spinal cord stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.

The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of lumbar pain.

A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and 80 years old suffering from refractory neuropathic pain of radicular origin with associated back pain will be included. Patients will be divided into two groups. One group with MSCS during the 12 months after the new generation electrode implantation and one group with CSCS during 6 months and MSCS between 6 and 12 months after the new generation electrode implantation.

The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing in relation to surgery and patient management.


Options:
A: Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)
B: Arm Label: Sequence 1; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Arm Label: Sequence 2; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Intervention Type: DEVICE; Name: High frequency spinal cord stimulation; Assigned to Arm(s): Sequence 1, Sequence 2
C: Arm Label: Spinal Cord Stimulation; Type: EXPERIMENTAL; Interventions: Device: WaveWriter | Arm Label: Conventional Medical Management; Type: OTHER; Interventions: Other: Conventional Medical Managament | Intervention Type: DEVICE; Name: WaveWriter; Assigned to Arm(s): Spinal Cord Stimulation | Intervention Type: OTHER; Name: Conventional Medical Managament; Assigned to Arm(s): Conventional Medical Management
D: Arm Label: Monocolumn spinal cord stimulation; Type: ACTIVE_COMPARATOR; Interventions: Device: comparison of spinal cord stimulation | Arm Label: Multicolumn spinal cord stimulation; Type: EXPERIMENTAL; Interventions: Device: comparison of spinal cord stimulation | Intervention Type: DEVICE; Name: comparison of spinal cord stimulation; Assigned to Arm(s): Monocolumn spinal cord stimulation, Multicolumn spinal cord stimulation

Answer: D