Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Study Overview
=================
Brief Summary
-----------------
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain

Official Title
-----------------
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Conditions
-----------------
Chronic Neuropathic Pain in the Low Back and Legs

Intervention / Treatment
-----------------
* Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bipolar then alternative field shape stimulation<br>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 | Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System<br>* Spinal cord stimulation for the management of chronic neuropathic pain<br>|
| Experimental: Alternative then bipolar field shape stimulation<br>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 | Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System<br>* Spinal cord stimulation for the management of chronic neuropathic pain<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preferred Field Shape | Number of participants preferring bipolar field shape and alternative field shape | 42 days post randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic neuropathic pain in the low back and legs, subperception spinal cord stimulation