Combining Mechanisms for Better Outcomes (COMBO)

Study Overview
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Brief Summary
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To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Detailed Description
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To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Official Title
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Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain

Conditions
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Chronic Pain, Back Pain

Intervention / Treatment
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* Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. 22 years of age or older at time of enrollment Able to independently read and complete all questionnaires and assessments provided in English Signed a valid, IRB-approved informed consent form (ICF) provided in English Key Exclusion Criteria: Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WaveWriter Settings<br>WaveWriter Programming | Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System<br>* The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.<br>|
| Active Comparator: Conventional Settings<br>Conventional Programming | Device: Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System<br>* The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Pain Responder Rate | Percentage of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization with no increase in opioid medications | 3 months post-randomization |