Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT03546738
• Date of registration: 23/05/2018
• Prospective Registration: Yes
• Primary sponsor: St. Olavs Hospital
• Public title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
• Scientific title: Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
• Date of first enrolment: September 5, 2018
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03546738
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Geir Bråthen, md prof
• Affiliation: St. Olavs Hospital

• Name: Sasha Gulati, md prof
• Affiliation: St. Olavs Hospital

Key inclusion & exclusion criteria

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

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pain, Postoperative

Back Pain With Radiation

Intervention(s)

Procedure: Burst Spinal Cord Stimulation

Device: SCS implant

Procedure: Sham spinal cord stimulation

Primary Outcome(s)

Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods [Time Frame: 12 months]

Secondary Outcome(s)

Change from baseline in back pain between active burst stimulation and placebo stimulation periods [Time Frame: 12 months]

Change from baseline in generic health-related quality of life measured with the Euro-Qol-5D (5L) between active burst stimulation and placebo stimulation periods [Time Frame: 12 months]

Change from baseline in leg pain between active burst stimulation and placebo stimulation periods [Time Frame: 12 months]

Change from baseline in daily physical activity between active burst stimulation and placebo stimulation periods [Time Frame: 12 months]

Secondary ID(s)

2018/475

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Norwegian University of Science and Technology