Spinal Cord Stimulation for Low Back Pain

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00205868
• Collaborator: (none)
• Enrollment: 304
• Locations: 30
• Actual Duration (Months): 36
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain.

Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Precision Spinal Cord Stimulation System	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
• Actual Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. [1 year]

   Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"

2. Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. [1 year]

   Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"

Secondary Outcome Measures

1. Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation [1 year]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;

2. Age ≥18 years;

3. Have pain of neuropathic origin;

4. Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.

Exclusion Criteria:

1. Enrollment in any research that would conflict with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Cullman	Alabama	United States	35055
2	Research Center	Daphne	Alabama	United States	36526
3	Research Center	Huntsville	Alabama	United States	35801
4	Research Center	Mesa	Arizona	United States	85206
5	Research Center	Los Angeles	California	United States	90095
6	Research Center	Pasadena	California	United States	91105
7	Research Center	San Diego	California	United States	92108
8	Research Center	Westminster	Colorado	United States	80401
9	Research Center	Jacksonville	Florida	United States	32224
10	Research Center	Jupiter	Florida	United States	33477
11	Research Center	Lewiston	Idaho	United States	83501
12	Research Center	Bloomington	Illinois	United States	61701
13	Research Center	Chicago	Illinois	United States	60611
14	Research Center	Oak Brook	Illinois	United States	60707
15	Research Center	Merrillville	Indiana	United States	46410
16	Research Center	Valparaiso	Indiana	United States	46410
17	Research Center	Boston	Massachusetts	United States	02215
18	Research Center	Pittsfield	Massachusetts	United States	01201
19	Research Center	Rochester	Minnesota	United States	55904
20	Research Center	Billings	Montana	United States	59101
21	Research Center	Winston-Salem	North Carolina	United States	27103
22	Research Center	Hamilton	Ohio	United States	45011
23	Research Center	Eugene	Oregon	United States	97401
24	Research Center	Allentown	Pennsylvania	United States	18104
25	Research Center	Philadelphia	Pennsylvania	United States	19107
26	Research Center	Spartanburg	South Carolina	United States	29302
27	Research Center	Murray	Utah	United States	84107
28	Research Center	Provo	Utah	United States	84604
29	Research Center	Cudahy	Wisconsin	United States	53220
30	Research Center	Rice Lake	Wisconsin	United States	54868

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Ramsin Benyamin, MD, Millenium Pain Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00205868
• Other Study ID Numbers: PM -SCS -120904
• First Posted: Sep 21, 2005
• Last Update Posted: Jun 18, 2021
• Last Verified: May 1, 2021

• Keywords provided by , ,: Back Pain; Low Back Pain; Chronic Pain; Spinal Cord Stimulation
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Chronic Pain

Study Results

Participant Flow

Pre-assignment Detail	Efforts were made but the information is not accessible at this time. Hence assignment not available.

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Period Title: Overall Study
STARTED	304
COMPLETED	304
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Description	Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Measure Participants	0

2. Primary Outcome

Title	Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.
Description	Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine"
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Measure Participants	0

3. Secondary Outcome

Title	Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Efforts were made but the information is not accessible at this time. Hence outcome measures not reported.

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
Measure Participants	0

Adverse Events

Time Frame	Adverse events were collected from enrollment through end of study.
Adverse Event Reporting Description	Efforts were made but the information is not accessible at this time. Hence adverse events not reported.
Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
All Cause Mortality
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/304 (0%)
Serious Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/304 (0%)
Other (Not Including Serious) Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/304 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.