Evidence: Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01036529
• Collaborator: (none)
• Enrollment: 28
• Locations: 18
• Arms: 2
• Duration (Months): 38.9
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome; Pain; Back Pain	Device: Precision Spinal Cord Stimulator; Procedure: Back Surgery	Phase 4

Detailed Description

The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Precision Spinal Cord Stimulator Spinal Cord Stimulation	Device: Precision Spinal Cord Stimulator; Programming settings will be specific to the individual needs in accordance with the labeling
Active Comparator: Back Surgery Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation	Procedure: Back Surgery; Different types of back surgery may be performed; Other Names: Discectomy Laminotomy Laminectomy Foraminotomy Foraminectomy Fusion with or without instrumentation

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment [3, 6- and 12- months post-index procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Primary pain type - neuropathic with concordant radicular or neurological findings

• Significant complaint of persistent or recurrent radicular leg pain, with or without low back pain

• One or more prior lumbosacral surgical procedures (no upper limit)

• At least 6 months duration of persistent or recurrent radicular leg pain, with or without low back pain

• Study candidates meet the criteria for a specific surgical intervention as recorded by a surgeon: pain refractory to conservative care, with concordant neurologic, tension, and/or mechanical signs and imaging findings of surgically remediable neural compression

• MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) that rules out pathology that might compromise SCS electrode placement or pathology, in addition to neural compression, that might contribute to the subject's pain

• All study candidates must pass study site's routine psychological/psychiatric evaluation for SCS before randomization to SCS or reoperation

• At least 18 years of age

• Subject signs informed consent

Exclusion Criteria:

• Chief complaint of mechanical low back pain (e.g. pain that a recumbent position relieves completely)

• Pain intensity of always 10 on a 0-10 Numerical Rating Scale over the past 6 months based on subject recall

• Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic stenosis

• Radiographically demonstrated (by myelographic block or its MRI equivalent) critical cauda equinal compression

• A disabling or potentially disabling neurologic deficit (e.g., foot drop, neurogenic bladder) in the distribution of a nerve root or roots caused by surgically remediable compression

• A predominance of non-organic signs on physical exam

• A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthrosis of the hip associated with groin pain as primary complaint)

• Significant substance abuse issues

• Major untreated psychiatric comorbidity

• Unresolved issues of secondary gain (e.g., litigation)

• Expected inability to report treatment outcome adequately

• Expected inability to operate SCS system

• Pregnancy (actual or planned)

• Life expectancy less than 3 years due to other serious medical condition(s)

• Active local or systemic infection

• Prior SCS procedure

• Presence of intrathecal drug pump

• Participation in another clinical study that would confound data of this study

• Occupational risk that would rule out SCS

• Medical or cardiac condition(s) or therapies, or foreseeable need for therapies or diagnostic tests (e.g., MRI), that preclude SCS and/or reoperation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic	La Jolla	California	United States	92037
2	University of California San Diego	La Jolla	California	United States	92037
3	Orthopedic Research Foundation	Savannah	Georgia	United States	31405
4	Millenium Pain Center	Bloomington	Illinois	United States	61701
5	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
6	The University of Illinois Medical Center	Chicago	Illinois	United States	60612
7	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21209
8	St. Patrick Hospital	Missoula	Montana	United States	59802
9	The Center for Clinical Research, LLC	Winston-Salem	North Carolina	United States	27103
10	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
11	Medical University of South Carolina	Charleston	South Carolina	United States	29425
12	Swedish Neuroscience Institute	Seattle	Washington	United States	98122
13	Pacific Medical Center	Seattle	Washington	United States	98144
14	Regina General Hospital	Regina	Saskatchewan	Canada	S4P 0W5
15	Hopital de Enfant-Jesus	Quebec		Canada	G1J 1Z4
16	CHU de Nantes-Hopital Laennec	Nantes Cedex		France	44093
17	Frenchay Hospital	Bristol		United Kingdom	BS16 1LE
18	James Cook University Hospital	Middlesbrough		United Kingdom	TS4 3BW

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Richard North, M.D., The Sandra and Malcolm Berman Brain & Spine Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01036529
• Other Study ID Numbers: A2005
• First Posted: Dec 21, 2009
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Boston Scientific Corporation: Spinal Cord Stimulation; Decompression; Fusion with or without instrumentation; Discectomy; Laminectomy; Laminotomy; Foraminotomy
• Additional relevant MeSH terms: Syndrome; Failed Back Surgery Syndrome

Study Results

Participant Flow

Recruitment Details	Subjects were recruited for participation from February 2010 to June 2012.
Pre-assignment Detail	A total of 274 subjects were screened for participation.After screening, 75 subjects were eligible for participation. Of the eligible subjects, 47 declined randomization. A total of 28 subjects were randomized.

Arm/Group Title	Precision Spinal Cord Stimulator	Back Surgery
Arm/Group Description	Precision Spinal Cord Stimulator Intervention	Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
Period Title: Overall Study
STARTED	13	15
Baseline Visit	10	13
Index Procedure	10	11
3 Month Follow-up	7	9
6 Month Follow-up	6	7
12 Month Follow-up	4	3
Requested Crossover	1	2
Crossover to Other Group	1	1
COMPLETED	0	0
NOT COMPLETED	13	15

Baseline Characteristics

Arm/Group Title	Precision Spinal Cord Stimulator	Back Surgery	Total
Arm/Group Description	Precision Spinal Cord Stimulation System	Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation	Total of all reporting groups
Overall Participants	11	14	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.3 (12)	57 (15.3)	54.9 (13.9)
Sex: Female, Male (Count of Participants)
Female	7 63.6%	4 28.6%	11 44%
Male	4 36.4%	10 71.4%	14 56%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 9.1%	1 7.1%	2 8%
White	7 63.6%	12 85.7%	19 76%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 27.3%	1 7.1%	4 16%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
Time Frame	3, 6- and 12- months post-index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Precision Spinal Cord Stimulator	Back Surgery
Arm/Group Description	Precision Spinal Cord Stimulation System	Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
Measure Participants	7	9
3 Month (7 subject Stimulation, 9 Subjects Surger)	0.86 7.8%	0.44 3.1%
6 Month (6 subjects for Stimulation and Surgery)	0.5 4.5%	0.5 3.6%
12 month (4 subjects for Stim, 3 subjects Surgery)	1.0 9.1%	0.33 2.4%

Adverse Events

Adverse Event Reporting Description	The adverse events for all subjects (including cross-over subjects) were collected within the group that each subject was originally randomized.
Arm/Group Title	Precision Spinal Cord Stimulator		Back Surgery
Arm/Group Description	Precision Spinal Cord Stimulation System		Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
All Cause Mortality
	Precision Spinal Cord Stimulator		Back Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Precision Spinal Cord Stimulator		Back Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		4/15 (26.7%)
Infections and infestations
Upper respiratory tract infection	0/13 (0%)	0	1/15 (6.7%)	1
Urinary Tract Infection	0/13 (0%)	0	1/15 (6.7%)	1
Injury, poisoning and procedural complications
Sternal Fracture	0/13 (0%)	0	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Back Pain	0/13 (0%)	0	1/15 (6.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma	0/13 (0%)	0	1/15 (6.7%)	1
Nervous system disorders
Radicular Pain	1/13 (7.7%)	1	0/15 (0%)	0
Renal and urinary disorders
Urinary Retention	0/13 (0%)	0	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Precision Spinal Cord Stimulator		Back Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/13 (23.1%)		2/15 (13.3%)
Gastrointestinal disorders
Nausea	1/13 (7.7%)	1	1/15 (6.7%)	1
Vomiting	0/13 (0%)	0	1/15 (6.7%)	1
General disorders
Implant site haematoma	1/13 (7.7%)	1	0/15 (0%)	0
Implant site pain	1/13 (7.7%)	1	0/15 (0%)	0
Infections and infestations
Wound infection staphylococcal	0/13 (0%)	0	1/15 (6.7%)	1
Injury, poisoning and procedural complications
Incision site pain	1/13 (7.7%)	1	0/15 (0%)	0
Incision site pruritis	1/13 (7.7%)	1	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/13 (15.4%)	2	0/15 (0%)	0
Back Pain	1/13 (7.7%)	1	0/15 (0%)	0
Neck Pain	1/13 (7.7%)	1	0/15 (0%)	0
Back Pain	0/13 (0%)	0	1/15 (6.7%)	1
Nervous system disorders
Dizziness	1/13 (7.7%)	1	0/15 (0%)	0
Headache	1/13 (7.7%)	1	1/15 (6.7%)	1
Neuralgia	1/13 (7.7%)	1	1/15 (6.7%)	1
Renal and urinary disorders
Dysuria	0/13 (0%)	0	1/15 (6.7%)	1

Limitations/Caveats

This study was terminated early due to slow enrollment. Only 28 of the 200 planned subjects were enrolled. Based on the small numbers and early termination, the primary outcome measures were not analyzed.

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.