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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2023-10-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)

NCT04571242

Chronic Back Pain

COMPLETED NA

DTM (TM) Spinal Cord Stimulation (SCS) Study

NCT04601454

Chronic Pain

COMPLETED NA

SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

NCT04676022

Chronic Pain

COMPLETED NA

Objective Data on Daily Activity in Patients Treated with SCS: the Intellis Study

NCT04710355

Failed Back Surgery Syndrome

COMPLETED

Spinal Cord Stimulation for Chronic and Intractable Back Pain

NCT00370695

Back Pain

TERMINATED NA

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.

Pain, Intractable Pain, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM)

Subjects will undergo a Trial Phase with DTM™ SCS programming. Stimulation will be delivered from an external neurostimulator. Those who have a "successful Trial Phase" will proceed to permanent implantation of the Intellis™ SCS system to evaluate DTM™ SCS therapy and will undergo up to 24 months of stimulation delivery.

Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the DTM™ SCS + CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the CMM group. If all SCS programming attempts fail, then DTM™ SCS therapy will be switched off and the subject will continue with their CMM treatment and will visit the clinic approximately a total of 18 months follow-up in the study (i.e. 6 months DTM™ SCS and 12 months CMM).

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Conventional Medical Management (CMM)

Intervention Type 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

Control Group - Conventional Medical Management (CMM) alone

The choice of appropriate CMM will be made by the Investigator as determined to be the best standard of care for each individual subject i.e. optimized individual conventional therapy. These treatments would be generally consistent with the American College of Physicians and the American Pain Society Guidelines as published in the Annals of Internal Medicine and European/UK guidelines. Subjects in this group will also undergo up to 24 months of CMM.

Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the DTM™ SCS therapy group. Following their device activation, they will attend visits approximately a total of 18 months follow-up in the study (i.e. 6 months CMM and 12 months DTM™ SCS).

Group Type ACTIVE_COMPARATOR

Conventional Medical Management (CMM)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No