Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Chronic Neuropathic Pain in the Low Back and Legs Clinical Trial

Official title:

Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02916498
• Other study ID #: A4062
• Status: Terminated
• Phase: N/A
• Start date: February 7, 2017
• Est. completion date: July 23, 2018

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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)

Related Conditions & MeSH terms

• Chronic Neuropathic Pain in the Low Back and Legs
• Neuralgia

Intervention

Device:
• Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
Spinal cord stimulation for the management of chronic neuropathic pain

Locations

Country	Name	City	State
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	James Cook University Hospital	Middlesborough

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Preferred Field Shape	Number of participants preferring bipolar field shape and alternative field shape	42 days post randomization