Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Not Applicable

Terminated

• Conditions: Chronic Neuropathic Pain in the Low Back and Legs
• Interventions: Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

• Registration Number: NCT02916498
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Study Start: 2017-02-07
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Results First Submitted: 2019-07-23
• Results First Submitted QC: 2019-09-10
• Results First Posted: 2019-10-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
• Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
• Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)

Key

Exclusion Criteria

• Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
• Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bipolar then alternative field shape stimulation	Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System	Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days
Alternative then bipolar field shape stimulation	Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System	Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days

Primary Outcome Measures

Name	Time	Method
Patient Preferred Field Shape	42 days post randomization	Number of participants preferring bipolar field shape and alternative field shape

Trial Locations

Locations (2)

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesborough, United Kingdom