Burst Crossover Trial

St. Olavs Hospital

Status: Enrolling

Conditions: Pain, Postoperative; Back Pain with Radiation

Treatments: Procedure: Sham spinal cord stimulation; Device: SCS implant; Procedure: Burst Spinal Cord Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05372822

2018/475-b

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
• Minimum pain intensity of 5/10 on the leg pain NRS at baseline
• Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
• Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
• Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period

Exclusion criteria

• Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
• History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
• Abnormal pain behavior and/or unresolved psychiatric illness.
• Unresolved issues of secondary gain or inappropriate medication use.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups

Burst SCS

Experimental group

Description:

Burst Spinal cord stimulation. SCS system implanted and burst stimulation given

Treatment:

Procedure: Burst Spinal Cord Stimulation

Device: SCS implant

Procedure: Sham spinal cord stimulation

Sham SCS

Sham Comparator group

Description:

Sham spinal cord stimulation. SCS system implanted but no stimulation given.

Treatment:

Procedure: Burst Spinal Cord Stimulation

Device: SCS implant

Procedure: Sham spinal cord stimulation