NCT02986074

CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.

Detailed description

The primary purpose of this study is to compare the therapeutic efficacy of the conventional, paresthesia mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more novel, anatomic midline-based approach that has the potential to streamline the workflow associated with the SCS treatment continuum.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Paresthesia mapping lead evaluation first	Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial
DEVICE	Anatomical midline lead evaluation first	Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2016-12-08
• Last updated: 2021-05-03
• Results posted: 2021-05-03

Locations

2 sites across 1 country: United Kingdom