Clinical trial NCT06442410: 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
Official title: Comparison of Differential Target Multiplexed Spinal Cord Stimulation (DTM™ SCS) Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Intractable
Pain, Chronic
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
Collaborators: name: SGX Group
First posted: 2024-06-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

* DTM™ SCS programming approach with Conventional Medical Management (CMM)
* CMM alone

There is an optional two-way crossover to the other treatment group available for all subjects who remain in the study at the 6-months visit.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Percentage of Individual Responders
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Individual Responders
timeFrame: 1 month
measure: Percentage of Individual Responders
timeFrame: 3 months
measure: Percentage of Individual Responders
timeFrame: 9 months
measure: Percentage of Individual Responders
timeFrame: 12 months
measure: Percentage of Individual Responders
timeFrame: 18 months
measure: Percentage of Individual Responders
timeFrame: 24 months
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 1 month
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 3 months
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 6 months
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 9 months
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 12 months
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 18 months
measure: Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
timeFrame: 24 months
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Wilrijk
country: Belgium
facility: GZA - Sint Augustinus Ziekenhuis
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: München
country: Germany
facility: München Klinik Bogenhausen
city: Elst
country: Netherlands
facility: Rijnstate - Locatie Elst
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Zeist
country: Netherlands
facility: Diakonessenhuis Locatie Zeist
city: A Coruña
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Medtronic
name: Mirit Argov
role: STUDY_DIRECTOR
References: