Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
174 participants
INTERVENTIONAL
2018-10-03
2021-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Managing Chronic Spinal Pain With Exercise and Neuromodulation
NCT06969456
Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome
NCT06272539
The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
NCT05802901
Group-based Mindfulness for Chronic Pain in the Primary Care Setting
NCT04129450
Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients
NCT00830596
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
WaveWriter Settings
WaveWriter Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
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.
Conventional Settings
Conventional Programming
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Wallace, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Pain and Supportive Care
Phoenix, Arizona, United States
UCSD Medical Center - Jacobs Medical Center
La Jolla, California, United States
Denver Back Pain Specialists
Greenwood Village, Colorado, United States
South Lake Pain Institute, Inc
Clermont, Florida, United States
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States
Michigan Pain Consultants
Grand Rapids, Michigan, United States
Forest Health Medical Center
Ypsilanti, Michigan, United States
KC Pain Centers
Lee's Summit, Missouri, United States
Carolinas Research Institute, LLC
Huntersville, North Carolina, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Toledo Clinic
Toledo, Ohio, United States
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
Precision Spine Care
Tyler, Texas, United States
EvergreenHealth Pain Care
Kirkland, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wallace MS, North JM, Phillips GM, Calodney AK, Scowcroft JA, Popat-Lewis BU, Lee JM, Washabaugh EP 3rd, Paez J, Bolash RB, Noles J, Atallah J, Shah B, Ahadian FM, Trainor DM, Chen L, Jain R. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184. doi: 10.2217/pmt-2022-0101. Epub 2023 Mar 3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A4070
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.