NCT03594266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

July 9, 2018

Results QC Date

March 9, 2023

Last Update Submit

July 6, 2023

Conditions

Chronic Low Back PainChronic Leg Pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change Since Conclusion of Commercial Trial in Numerical Rating Scale (NRS) for Pain (Overall) Evaluated Separately for Each Study SCS Therapy

    In-office visit 1 at approximately 7 days and in-office visit 3 at approximately 21 days, average of 14 days

  • Investigational Device-related Adverse Event-free Rate

    Baseline and in-office visit 3, average of 21 days

Study Arms (2)

Therapy A Spinal Cord Stimulation Parameter Set

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

Therapy B Spinal Cord Stimulation Parameter Set

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

Interventions

Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated componentsDEVICE

Therapy A stimulation patterns

Therapy A Spinal Cord Stimulation Parameter Set
Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated componentsDEVICE

Therapy B stimulation patterns

Therapy B Spinal Cord Stimulation Parameter Set

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Hope Research Institute

Peoria, Arizona, 85381, United States

Location

Arizona Pain

Scottsdale, Arizona, 85258, United States

Location

Integrated Pain Management (IPM) Medical Group

Walnut Creek, California, 94598, United States

Location

Center for Interventional Pain and Spine

Wilmington, Delaware, 19711, United States

Location

Coastal Orthopedics

Bradenton, Florida, 34209, United States

Location

Pain Care, LLC

Stockbridge, Georgia, 30281, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Neuroscience Research Center DBA Kansas Pain Management

Overland Park, Kansas, 66210, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

St. Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

Location

KC Pain Centers

Lee's Summit, Missouri, 64086, United States

Location

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Integrated Pain Solutions

Columbus, Ohio, 43240, United States

Location

Delaware Valley Pain and Spine Institute

Trevose, Pennsylvania, 19053, United States

Location

Northwest Pain Care, Inc.

Spokane, Washington, 99201, United States

Location

Related Publications (1)

  • Kapural L, Patterson DG, Li S, Hatheway J, Hunter C, Rosen S, Fishman M, Gupta M, Sayed D, Christopher A, Burgher A, McJunkin T, Ross EL, Provenzano D, Amirdelfan K. Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Neuromodulation. 2023 Oct;26(7):1400-1411. doi: 10.1016/j.neurom.2023.05.006. Epub 2023 Aug 16.

    PMID: 37589641DERIVED

Results Point of Contact

Title
Crystal Miller
Organization
BiotronikUS
crystal.miller@biotronik.com
503-475-4984

Study Officials

  • Leonardo Kapural, MD

    Carolinas Pain Institute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 20, 2018

Study Start

August 1, 2018

Primary Completion

March 20, 2020

Study Completion

March 27, 2020

Last Updated

July 10, 2023

Results First Posted

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(18)