Back to resultsField Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Primary Purpose
Chronic Neuropathic Pain in the Low Back and Legs
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
Sponsored by
About this trial
This is an interventional other trial for Chronic Neuropathic Pain in the Low Back and Legs focused on measuring chronic neuropathic pain in the low back and legs, subperception spinal cord stimulation
Eligibility Criteria
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)
Sites / Locations
- St. Bartholomew's Hospital
- James Cook University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bipolar then alternative field shape stimulation
Alternative then bipolar field shape stimulation
Arm Description
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
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
Outcomes
Primary Outcome Measures
Patient Preferred Field Shape
Number of participants preferring bipolar field shape and alternative field shape
Secondary Outcome Measures
Full Information
NCT ID
NCT02916498
First Posted
September 22, 2016
Last Updated
January 27, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02916498
Brief Title
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Official Title
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to a business decision
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
July 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neuropathic Pain in the Low Back and Legs
Keywords
chronic neuropathic pain in the low back and legs, subperception spinal cord stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bipolar then alternative field shape stimulation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Alternative then bipolar field shape stimulation
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
Intervention Description
Spinal cord stimulation for the management of chronic neuropathic pain
Primary Outcome Measure Information:
Title
Patient Preferred Field Shape
Description
Number of participants preferring bipolar field shape and alternative field shape
Time Frame
42 days post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Eldabe, MD
Organizational Affiliation
James Cook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7Be
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
12. IPD Sharing Statement
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Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
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