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 | Completed Results FDA Device

• 2 other identifiers: MDT24011ISRCTN10663814
• Study Type: interventional
• Target: 115
• Locations: 4 countries
• Sites: 12

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.

Conditions

Pain, Intractable; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (13)

• Percentage of Individual Responders

  1 month

• Percentage of Individual Responders

  3 months

• Percentage of Individual Responders

  9 months

• Percentage of Individual Responders

  12 months

• Percentage of Individual Responders

  18 months

Study Arms (2)

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

EXPERIMENTAL

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).

Device: DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system; Other: Conventional Medical Management (CMM)

Control Group - Conventional Medical Management (CMM) alone

ACTIVE COMPARATOR

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).

Other: Conventional Medical Management (CMM)

Interventions

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• MedtronicNeuro: lead
• SGX Group: collaborator

Study Sites (12)

AZ Delta

Roeselare, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

GZA - Sint Augustinus Ziekenhuis

Wilrijk, Belgium

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

München Klinik Bogenhausen

München, Germany

Location

Rijnstate - Locatie Elst

Elst, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Diakonessenhuis Locatie Zeist

Zeist, Netherlands

Location

Hospital Clínico Universitario de Santiago

A Coruña, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Related Links

• ISRCTN Registry posting

MeSH Terms

Conditions

Pain, Intractable; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thanh Tran
• Organization: Medtronic

thanh.tran2@medtronic.com

7278082652

Study Officials

• Mirit Argov

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: July 24, 2020
• Primary Completion: May 9, 2022
• Study Completion: October 17, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); NL (3); ES (4); BE (3)