Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

Boston Scientific

Status: Terminated

Conditions: Chronic Neuropathic Pain in the Low Back and Legs

Treatments: Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02916498

A4062

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

16 participants in 2 patient groups

Bipolar then alternative field shape stimulation

Active Comparator group

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

Treatment:

Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System

Alternative then bipolar field shape stimulation

Experimental group

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

Treatment:

Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System