Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02916498
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site: 8
• Patients Per Site Per Month: 0.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Neuropathic Pain in the Low Back and Legs	Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
• Actual Study Start Date: Feb 7, 2017
• Actual Primary Completion Date: Jul 23, 2018
• Actual Study Completion Date: Jul 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System; Spinal cord stimulation for the management of chronic neuropathic pain
Experimental: 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	Device: Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System; Spinal cord stimulation for the management of chronic neuropathic pain

Outcome Measures

Primary Outcome Measures

1. Patient Preferred Field Shape [42 days post randomization]

   Number of participants preferring bipolar field shape and alternative field shape

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Bartholomew's Hospital	London		United Kingdom	EC1A 7Be
2	James Cook University Hospital	Middlesborough		United Kingdom	TS4 3BW

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Sam Eldabe, MD, James Cook University Hospital

Study Documents (Full-Text)

• Study Protocol - May 2, 2017

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02916498
• Other Study ID Numbers: A4062
• First Posted: Sep 27, 2016
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• 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
• Keywords provided by Boston Scientific Corporation: chronic neuropathic pain in the low back and legs; subperception spinal cord stimulation
• Additional relevant MeSH terms: Neuralgia

Study Results

Participant Flow

Pre-assignment Detail	16 subjects were enrolled in the study. 10 were withdrawn prior to randomization. 6 were randomized. Statistically relevant conclusions cannot be made from this small sample size.

Arm/Group Title	Bipolar Then Alternative Field Shape Stimulation	Alternative Then Bipolar Field Shape Stimulation
Arm/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	Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field stimulation for 21 days, then bipolar shape stimulation for 21 days
Period Title: First Intervention, 21 Days
STARTED	2	4
COMPLETED	2	4
NOT COMPLETED	0	0
Period Title: First Intervention, 21 Days
STARTED	2	4
COMPLETED	2	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bipolar Then Alternative Field Shape Stimulation	Alternative Then Bipolar Field Shape Stimulation	Total
Arm/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	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	Total of all reporting groups
Overall Participants	2	4	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	1 25%	3 50%
>=65 years	0 0%	3 75%	3 50%
Sex: Female, Male (Count of Participants)
Female	0 0%	2 50%	2 33.3%
Male	2 100%	2 50%	4 66.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	2 100%	4 100%	6 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bipolar Then Alternative Field Shape Stimulation	Alternative Then Bipolar Field Shape Stimulation
Arm/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	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
Measure Participants	2	4
Preferred Bipolar Field Shape	2 100%	2 50%
Preferred Alternative Field Shape	0 0%	2 50%

Adverse Events

Time Frame	Adverse events reported from randomization to 42 days post randomization
Arm/Group Title	Bipolar Field Shape Stimulation		Alternative Field Shape Stimulation
Arm/Group Description	Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar 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
All Cause Mortality
	Bipolar Field Shape Stimulation		Alternative Field Shape Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Bipolar Field Shape Stimulation		Alternative Field Shape Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Bipolar Field Shape Stimulation		Alternative Field Shape Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.