Combining Mechanisms for Better Outcomes (COMBO)



Status:Recruiting
Conditions:Back Pain, Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:22 - Any
Updated:12/5/2018
Start Date:October 3, 2018
End Date:September 30, 2021
Contact:Natalie Bloom Lyons, MA
Email:natalie.bloomlyons@bsci.com
Phone:763-228-9040

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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

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.

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.

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, pregnant 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
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