Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)

Chronic Low Back Pain Clinical Trial

Official title:

Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594266
• Other study ID #: BENEFIT-02
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: March 27, 2020

Study information

• Verified date: July 2023
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study stimulation testing following the conclusion of a successful SCS commercial trial.

Description:

The study population will consist of patients with chronic low back and/or leg pain who have been identified as candidates for trial testing of a commercially available SCS system including percutaneous SCS trial lead(s), but have not yet undergone trial lead implant. The commercial trial test period will be conducted independently from the study according to standard of care. The commercial trial period is referred to as the "trial" and the BENEFIT-02 interventional study stimulation period is referred to as the "study".

Potential subjects will be identified by the investigator from their general patient population and must meet all of the study inclusion and none of the study exclusion criteria evaluated at the time of enrollment. Once study eligibility is confirmed, written informed consent is obtained, after which enrollment visit data will be collected. Subjects will be considered fully enrolled after being randomly assigned to receive one of two study SCS therapies.

To participate in this study, subjects must be willing to undergo an extended 14 day testing period following the conclusion of their commercial trial, where their existing SCS trial lead(s) will be connected to a BIOTRONIK study stimulator and one of two randomly assigned study SCS therapies will be administered for an additional 12 days after a two day washout period. After completion of the 12 day study testing period, the subject's participation in the study ends, the study stimulator will be disconnected, and the commercial SCS trial lead(s) will be removed according to the standard clinical routine.

This feasibility study includes the assessment of two primary endpoints and two secondary endpoints that are designed to provide preliminary information regarding the effectiveness and safety of the two study SCS therapies under investigation in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 27, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than or equal to 18 years

• Able to understand the nature of the study and provide written informed consent

• Able to read, understand, and speak English

• Willing and able to comply with all study requirements, including all required procedures, phone calls and study visits

• Planned to undergo a commercial SCS trial of standard duration for the treatment of low back and/or leg pain with a commercially available SCS system as prescribed by a physician(s) according to FDA approved indications for use

• Planned utilization of preoperative antibiotics for SCS commercial trial

• Planned placement of two eight-electrode SCS trial leads (or at least one 16- electrode SCS trial lead) using a suitable technique for an extended trial (e.g. tunneling approach of a minimum of 3-4 cm, or buried lead trial) with at least one lead covering the T8 or T9 vertebral level

• Incoming Numerical Rating Scale (NRS) for pain (overall) of at least 6 (collected prior to the commercial trial)

• Passed psychological evaluation

• Negative MRSA screening result

• Negative MSSA screening result or documentation of subsequent decolonization routine if MSSA positive

• For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result = 7.5%

Exclusion Criteria:

• Enrolled in any investigational SCS stimulation trial, for which the SCS system is not commercially available

• Presence of any life-threatening, underlying illness separate from their indication for SCS therapy

• Patients reporting pregnancy at the time of enrollment

• Patients with poor compliance for pain management regimen

• Patients currently involved in an active workers compensation claim and/or active litigation related to injury associated with indication for SCS

• Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to baseline data collection

• Patients with an implanted pacemaker, defibrillator, or other medical contraindications for SCS therapy

• Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator

• Patients immunocompromised and/or at high risk for infection

• Patients with morphine equivalent dose > 120 units

• Patients with documented history of allergic response or sensitivity to material(s) required for the study (e.g. silver impregnated antibacterial dressing, adhesives, titanium, silicone, etc.)

• Patients with a documented history of clostridium difficile

Related Conditions & MeSH terms

• Chronic Leg Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components
Therapy A stimulation patterns
• Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
Therapy B stimulation patterns

Locations

Country	Name	City	State
United States	Coastal Orthopedics	Bradenton	Florida
United States	St. Louis Pain Consultants	Chesterfield	Missouri
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	Integrated Pain Solutions	Columbus	Ohio
United States	Kansas University Medical Center	Kansas City	Kansas
United States	KC Pain Centers	Lee's Summit	Missouri
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Neuroscience Research Center DBA Kansas Pain Management	Overland Park	Kansas
United States	Hope Research Institute	Peoria	Arizona
United States	Nevada Advanced Pain Specialists	Reno	Nevada
United States	Arizona Pain	Scottsdale	Arizona
United States	Premier Pain Centers	Shrewsbury	New Jersey
United States	Northwest Pain Care, Inc.	Spokane	Washington
United States	Pain Care, LLC	Stockbridge	Georgia
United States	Delaware Valley Pain and Spine Institute	Trevose	Pennsylvania
United States	Integrated Pain Management (IPM) Medical Group	Walnut Creek	California
United States	Center for Interventional Pain and Spine	Wilmington	Delaware
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy	The purpose of primary endpoint 1 is to evaluate the change since baseline in Numerical Rating Scale (NRS) for pain (overall) for each study SCS therapy. The evaluation of primary endpoint 1 is based on the NRS for pain (overall) obtained at the final study testing visit compared with the baseline measurement obtained prior to initiation of the commercial trial period, for subjects randomized to each study SCS therapy. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.	Baseline and in-office visit 3, average of 21 days
Primary	Inter-therapy Comparison of Change Since Baseline in Numerical Rating Scale (NRS) for Pain (Overall)	The purpose of primary endpoint 2 is to provide an inter-therapy comparison of change since baseline in Numerical Rating Scale (NRS) for pain (overall). Primary endpoint 2 analyses includes all participants included in primary endpoint 1 analyses. Numerical Rating Scale (NRS) was collected for overall pain experienced over the past 24 hours on a scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain.	Baseline and in-office visit 3, average of 21 days
Secondary	Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy	The evaluation of secondary endpoint 1 will be based on Numerical Rating Scale (NRS) for overall pain experienced over the past 24 hours (scale of 0-10, with 0 being No Pain and 10 being Worst Possible Pain) obtained at conclusion of commercial trial compared to NRS for overall pain at the final study testing visit	In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days
Secondary	Investigational Device-related Adverse Event-free Rate	The evaluation of secondary endpoint 2 will be based on the number of subjects free from investigational device-related adverse events assessed at in-office visit 1 (randomization visit) through in-office visit 3 (study completion). The investigational device-related adverse event-free rate was pre-defined within the protocol as the overall rate from all implanted Prospera SCS devices, regardless of randomized therapy output setting (Therapy A or Therapy B).	Baseline and in-office visit 3, average of 21 days