Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery

MedtronicNeuro115 enrolled

Overview

The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Pain, Intractable Pain, Chronic

Interventions

Conventional Medical Management (CMM)OTHER

The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be a candidate for SCS system (trial and implant) * Have been diagnosed with chronic, refractory axial low back pain with or without lower limb pain, with a neuropathic component as assessed by the investigator, 6 months refractory to conventional therapy and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment * Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment * Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided. * Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent * Be 18 years of age or older at the time of enrollment * Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study * Be willing and able to comply with study-related requirements, procedures, and visits Exclusion Criteria: * Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) * Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator * Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the Investigator * Be concurrently participating in another clinical study * Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc. * Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator * Has mechanical spine instability as determined by the Investigator * Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief * Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator * Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim * Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)

Locations (12)

AZ Delta

Roeselare, Belgium

AZ Nikolaas

Sint-Niklaas, Belgium

GZA - Sint Augustinus Ziekenhuis

Wilrijk, Belgium

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

München Klinik Bogenhausen

München, Germany

Rijnstate - Locatie Elst

Elst, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Diakonessenhuis Locatie Zeist

Zeist, Netherlands

Hospital Clínico Universitario de Santiago

A Coruña, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

...and 2 more locations

Outcomes

Primary Outcomes

Percentage of Individual Responders

Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.

Time frame: 6 months

Secondary Outcomes

Percentage of Individual Responders

Time frame: 1 month

Percentage of Individual Responders

Time frame: 3 months

Percentage of Individual Responders

Time frame: 9 months

Percentage of Individual Responders

Time frame: 12 months

Percentage of Individual Responders

Time frame: 18 months

Percentage of Individual Responders

Time frame: 24 months