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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

NCT06442410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2024-11-07

Study results available
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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.

Conditions

  • Pain, Intractable
  • Pain, Chronic

Interventions

DEVICE

DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system

Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.

OTHER

Conventional Medical Management (CMM)

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

Sponsors & Collaborators

  • SGX Group

    collaborator INDUSTRY

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Mirit Argov · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2022-05-09
Completion
2023-10-17
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442410 on ClinicalTrials.gov