Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-07

Study Completion Date

2018-07-23

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Neuropathic Pain in the Low Back and Legs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bipolar then alternative field shape stimulation

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

Group Type ACTIVE_COMPARATOR

Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Intervention Type DEVICE

Spinal cord stimulation for the management of chronic neuropathic pain

Alternative then bipolar field shape stimulation

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

Group Type EXPERIMENTAL

Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Intervention Type DEVICE

Spinal cord stimulation for the management of chronic neuropathic pain

Interventions

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Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Spinal cord stimulation for the management of chronic neuropathic pain

Intervention Type DEVICE

Eligibility Criteria

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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)

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No