High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01624740
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Low Rate Stimulation; Device: High Rate Stimulation	N/A

Detailed Description

This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Rate Followed By High Rate The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days.	Device: Low Rate Stimulation; Stimulation was given at a rate of 2 Hz.; Device: High Rate Stimulation; Stimulation was given at a rate of 1200 Hz.
Experimental: High Rate Followed By Low Rate The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days.	Device: Low Rate Stimulation; Stimulation was given at a rate of 2 Hz.; Device: High Rate Stimulation; Stimulation was given at a rate of 1200 Hz.

Outcome Measures

Primary Outcome Measures

1. Change in Back Pain Intensity [For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).]

   Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Chronic intractable pain of the trunk and/or limbs

• Documented history of trunk and/or limb pain of at least 180 days

• Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit

• Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit

• If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation

• Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations

• Subject is able to independently read and complete all questionnaires and/or assessments provided in English

• 18 years of age or older when written informed consent is obtained

• Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Exclusion Criteria:

• Unable to operate the Precision Plus system

• Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine

• Is a high surgical risk

• Is diabetic

• Is immunocompromised

• Currently on any anticoagulant medications that cannot be discontinued during perioperative period

• Untreated major depression or untreated generalized anxiety disorder

• Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder

• Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8

• Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care

• Current abuse of alcohol or illicit drugs

• Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).

• Subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

• Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator

• Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Pain Spinal Diagnostic	Carlsbad	California	United States	92009

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Omid Khodai, OD, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01624740
• Other Study ID Numbers: A7001
• First Posted: Jun 21, 2012
• Last Update Posted: Mar 20, 2015
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Pre-assignment Detail	Although 20 subjects enrolled (11 to receive low rate stimulation first, 9 to receive high rate stimulation first), 2 subjects randomized to first receive low rate stimulation were withdrawn prior to stimulation due to difficulties implanting the device. Thus, 18 out of 20 enrolled subjects (9 from each group) started their first intervention.

Arm/Group Title	Low Rate Followed By High Rate	High Rate Followed By Low Rate
Arm/Group Description	The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.	The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
Period Title: First Intervention (3-4 Days)
STARTED	9	9
COMPLETED	9	9
NOT COMPLETED	0	0
Period Title: First Intervention (3-4 Days)
STARTED	9	9
COMPLETED	9	9
NOT COMPLETED	0	0
Period Title: First Intervention (3-4 Days)
STARTED	9	9
COMPLETED	8	9
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Low Rate Followed By High Rate	High Rate Followed By Low Rate	Total
Arm/Group Description	Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.	Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.	Total of all reporting groups
Overall Participants	11	9	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (10.57)	49.4 (9.49)	56.5 (11.81)
Sex: Female, Male (Count of Participants)
Female	8 72.7%	6 66.7%	14 70%
Male	3 27.3%	3 33.3%	6 30%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	9 81.8%	8 88.9%	17 85%
Hispanic or Latino	2 18.2%	1 11.1%	3 15%
Region of Enrollment (participants) [Number]
United States	11 100%	9 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Change in Back Pain Intensity
Description	Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
Time Frame	For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Rate Subperception Precision SCS Trial Therapy	High Rate Subperception Precision SCS Trial Therapy
Arm/Group Description	Stimulation was given at a rate of 2 Hz as either a first or second intervention.	Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
Measure Participants	18	17
Mean (Standard Deviation) [Percent Change From Baseline]	20.9 (31.6)	25.6 (38.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Low Rate Subperception Precision SCS Trial Therapy, High Rate Subperception Precision SCS Trial Therapy
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.74
	Comments
	Method	ANOVA
	Comments	Period effect p=0.11

Adverse Events

Time Frame	7-9 days
Adverse Event Reporting Description	Trial lead insertion was on Day 0, followed by 2 study periods lasting 3-4 days each. Though 18 subjects started stimulation, 20 subjects enrolled and had procedures performed. Two subjects withdrew after attempted lead insertion but before stimulation. Thus, the "At Risk" population during trial lead insertion is reported as 20, not 18.
Arm/Group Title	Trial Lead Insertion		Low Frequency Stimulation		High Frequency Stimulation
Arm/Group Description	All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.		Stimulation was given at 2 Hz.		Stimulation was given at 1200 Hz.
All Cause Mortality
	Trial Lead Insertion		Low Frequency Stimulation		High Frequency Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Trial Lead Insertion		Low Frequency Stimulation		High Frequency Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Trial Lead Insertion		Low Frequency Stimulation		High Frequency Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		1/18 (5.6%)		5/18 (27.8%)
Gastrointestinal disorders
Abdominal Pain	0/20 (0%)	0	0/18 (0%)	0	1/18 (5.6%)	1
General disorders
Administration Site Condition (Device Stimulation Issues)	0/20 (0%)	0	1/18 (5.6%)	0	4/18 (22.2%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.