Combining Mechanisms for Better Outcome… | Clinical Trial

Key information

Conditions

Chronic Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Pain and Supportive Care, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System

Device

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.

Primary outcomes

Overall Pain Responder Rate

Time frame: 3 months post-randomization

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: COMBO

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2021
First posted: Oct 1, 2018
Registry last updated: Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed