A Multi-Center Controlled Study to characterize the real-world outcomes of High Rate Spinal Cord Stimulation therapy using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System

A Multi-Center Controlled Study to characterize the real-world outcomes of High Rate Spinal Cord Stimulation therapy using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System - VELOCITY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42937

Enrollment

Registered

2016-10-27

Start date

2016-11-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

continued back pain after surgery Difficult to treat low back pain

Interventions

Routine implantation of the Boston Scientific*s Precision SCS System with MultiWave Technology

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Complaint of persistent or recurrent low back pain for at least 180 days prior to Screening -No back surgery within 6 months prior to Screening -Average low back pain intensity of 6 or greater on a 0-10 numerical rating scale during Screening (NRS) as evaluated by interview -Baseline Oswestry Disability Index score >40 and

Exclusion criteria

Exclusion criteria: -Average leg pain is greater than or equal to average low back pain during Screening (NRS). -Radiographic evidence of spinal instability requiring fusion -Require implantation of lead(s) in the cervical epidural space -Requires implantation of paddle-style SCS lead(s) via a laminotomy and/or laminectomy -Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Design outcomes

Primary

Measure	Time frame
Low back pain responder rate at 3 months post-activation as compared with Baseline. A responder is defined as *30% low back pain reduction from Baseline without change in opioids.	—

Secondary

Measure	Time frame
Secundary endpoints: Change in average low back pain from Baseline to 3 months post-Activation (Numeric Rating Scale) Change in average leg pain from Baseline to 3 months post-Activation (NRS) Percent pain relief of low back pain at 3 months post-Activation Percent pain relief of leg pain at 3 months post-Activation Change in low back pain with activity from Baseline to 3 months post-Activation (NRS) Change in leg pain with activity from Baseline to 3 months post-Activation (NRS) Patient global impression of change at 3 months post-Activation Change in disability from Baseline to 3 months post-Activation (ODI v2.1a) Change in quality of life from Baseline to 3 months post-Activation (SF-36v2) Exploratory endpoints: Change in average low back pain from Baseline through 6, 12 months post-Activation (NRS) Change in average leg pain intensity from Baseline through 6, 12 months post-Activation (NRS) Change in low back pain intensity with activity from Baseline through 6, 12 months post-Activation (NRS) Change in leg pain intensity with activity from Baseline through 6, 12 months post-Activation (NRS) Percent pain relief of low back pain through 6, 12 months post-Activation Percent pain relief of leg pain through 6, 12 months post-Activation Change in average daily leg pain intensity (NRS) from Baseline through 3, 12 months post-activation (Diary) Change in average daily low back pain intensity (NRS) from Baseline through 3, 12 months post-activation (Diary) Change in disability from Baseline Visit through 6, 12 months post-Activation (ODI v2.1a) Patient global impression of change through 6, 12 months post-Activation Change in quality of life from Baseline Visit through 6, 12 months post-Activation (SF-36v2) Change in opioid prescription from Baseline through 6, 12 months post-Activation (Concomitant Medications) Health economic endpoint: Economic value of HR-SCS at 12 months post-Activation (RUI, SF-36v2, Concomitant Medications, Proc	—

Measure

Time frame

Secundary endpoints: Change in average low back pain from Baseline to 3 months post-Activation (Numeric Rating Scale) Change in average leg pain from Baseline to 3 months post-Activation (NRS) Percent pain relief of low back pain at 3 months post-Activation Percent pain relief of leg pain at 3 months post-Activation Change in low back pain with activity from Baseline to 3 months post-Activation (NRS) Change in leg pain with activity from Baseline to 3 months post-Activation (NRS) Patient global impression of change at 3 months post-Activation Change in disability from Baseline to 3 months post-Activation (ODI v2.1a) Change in quality of life from Baseline to 3 months post-Activation (SF-36v2) Exploratory endpoints: Change in average low back pain from Baseline through 6, 12 months post-Activation (NRS) Change in average leg pain intensity from Baseline through 6, 12 months post-Activation (NRS) Change in low back pain intensity with activity from Baseline through 6, 12 months post-Activation (NRS) Change in leg pain intensity with activity from Baseline through 6, 12 months post-Activation (NRS) Percent pain relief of low back pain through 6, 12 months post-Activation Percent pain relief of leg pain through 6, 12 months post-Activation Change in average daily leg pain intensity (NRS) from Baseline through 3, 12 months post-activation (Diary) Change in average daily low back pain intensity (NRS) from Baseline through 3, 12 months post-activation (Diary) Change in disability from Baseline Visit through 6, 12 months post-Activation (ODI v2.1a) Patient global impression of change through 6, 12 months post-Activation Change in quality of life from Baseline Visit through 6, 12 months post-Activation (SF-36v2) Change in opioid prescription from Baseline through 6, 12 months post-Activation (Concomitant Medications) Health economic endpoint: Economic value of HR-SCS at 12 months post-Activation (RUI, SF-36v2, Concomitant Medications, Proc

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)