Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
Brief Summary: Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.

'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.

The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.

The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.


Options:
A: Arm Label: SCS + OMM; Type: ACTIVE_COMPARATOR; Interventions: Device: Spinal Cord Stimulation (SCS), Drug: Optimal Medical Management (OMM) | Arm Label: OMM alone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Optimal Medical Management (OMM) | Intervention Type: DEVICE; Name: Spinal Cord Stimulation (SCS); Assigned to Arm(s): SCS + OMM | Intervention Type: DRUG; Name: Optimal Medical Management (OMM); Assigned to Arm(s): OMM alone, SCS + OMM
B: Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): N/A
C: Arm Label: Tonic; Type: EXPERIMENTAL; Interventions: Procedure: dorsal column stimulator | Arm Label: Sham; Type: EXPERIMENTAL; Interventions: Procedure: dorsal column stimulator | Arm Label: burst; Type: EXPERIMENTAL; Interventions: Procedure: dorsal column stimulator | Intervention Type: PROCEDURE; Name: dorsal column stimulator; Assigned to Arm(s): Sham, Tonic, burst
D: Arm Label: Burst SCS; Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation, Device: SCS implant | Arm Label: Sham SCS; Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation, Device: SCS implant | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst SCS, Sham SCS | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst SCS, Sham SCS | Intervention Type: DEVICE; Name: SCS implant; Assigned to Arm(s): Burst SCS, Sham SCS

Answer: D