Pain Management Clinical Trials

COMBO

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

Description
The COMBO Study is a clinical research study designed 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. The WaveWriter SCS System will be evaluated based on how well it treats chronic low back pain and/or leg pain and if there are any side effects.

Currently enrolling

Who may be eligible to participate?
Adults 22 years of age or older with chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. Other inclusion and exclusion criteria may apply.

What does participation involve?
Patients will be asked to complete pain, health, well-being and quality of life questionnaires as part of study visits. The total study duration per subject is approximately 15 months which includes a 1 year post-procedure follow-up period.

Investigator: Jennifer Lee, MD, EvergreenHealth Pain Care

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


RELIEF

A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Description
The RELIEF study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain. The goal of the RELIEF study is to collect information about adult chronic pain patients who are using a Boston Scientific neurostimulation system.

Currently enrolling

Who may be eligible to participate?
Adults with chronic low back pain or chronic leg pain who is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain. Eligible subjects must be 18 years of age or older. Other inclusion and exclusion criteria may apply.

What does participation involve?
If it is determined that you have met all of the study requirements and are willing to participate in the study, you will:
• Be required to provide data at a Baseline, Trial and Implant visit.
• Be asked to complete pain drawings and questionnaires related to your experience with pain
• Be scheduled for follow-up visits at your study doctor’s office: 6, 12, 24, and 36 months after your trial procedure.
• You may receive compensation for your participation in this study.

Investigator: Jennifer M Lee, MD, EvergreenHealth Pain Care

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


NAVITAS

A Study to Characterize the Relationship between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients treated with Boston Scientific Neurostimulation Systems

Description
The goal of the NAVITAS Study is to collect information about adult chronic pain patients who are using a Boston Scientific neurostimulation system.

Currently enrolling

Who may be eligible to participate?
Adults with chronic low back pain or chronic leg pain who are or will be implanted with Boston Scientific’s neurostimulation system. Other inclusion and exclusion criteria may apply.

What does participation involve?
If it is determined that you have met all of the study requirements and are willing to participate in the study, you will:

  • Be scheduled for follow-up visits at your study doctor’s office: 3, 6, 9, 12, optional 24, and optional 36 months after your trial procedure.
  • Be asked to complete questionnaires related to your experience with pain
  • Be asked to wear a small adhesive patch, wear a watch and use a smart phone to collect information about your pain during the study.
  • Be asked to do some walking, balance, and movement activities in your study doctor’s office.
  • You may receive compensation for your participation in this study.

Investigator: Jennifer M Lee, MD, EvergreenHealth Pain Care

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com