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CompletedNCT06442410Updated Nov 7, 2024Results posted

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

An interventional study of DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system and Conventional Medical Management (CMM) in Pain, Intractable and Pain, Chronic, sponsored by MedtronicNeuro. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Jul 2020, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Intractable
  • Pain, Chronic
03

In context

Pain, Intractable

90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.

This study's enrollment of 115 is above the median of 60 across 64 interventional studies indexed under Pain, Intractable.

Browse Pain, Intractable studies →

Lead sponsor

MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Browse MedtronicNeuro studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be a candidate for SCS system (trial and implant)
  • Have been diagnosed with chronic, 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 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

Exclusion Criteria:

  • Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
  • Has a medical, anatomical, and/or psychosocial condition that is 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 . If female, sexually active, and childbearing age, subject must be willing to use a reliable form of .)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    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).

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

  • Active comparator
    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).

    Other: Conventional Medical Management (CMM)

Interventions

  • DeviceDTM™ 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.

  • OtherConventional 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

06

What researchers measure

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.

    Time frame: 6 months

Secondary 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.

    Time frame: 1 month

  2. 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: 3 months

  3. 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: 9 months

  4. 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: 12 months

  5. 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: 18 months

  6. 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: 24 months

  7. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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: 1 month

  8. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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: 3 months

  9. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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

  10. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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: 9 months

  11. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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: 12 months

  12. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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: 18 months

  13. Change From Baseline in Visual Analog Scale (VAS) Back Pain Score

    Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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: 24 months

07

Results

Posted Nov 7, 2024

Participant flow

Overall Non-Crossover
Participant flow — Overall Non-Crossover
MilestoneTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Started5557
Completed404
Not completed1553
Optional Crossover at 6 Month
Participant flow — Optional Crossover at 6 Month
MilestoneTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Started050
Completed039
Not completed011

Outcome measures

PrimaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders402
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryPercentage 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:
1 month
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders411
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryPercentage 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:
3 months
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders413
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryPercentage 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:
9 months
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders370
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryPercentage 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:
12 months
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders360
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryPercentage 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:
18 months
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders371
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryPercentage 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:
24 months
Reported as:
Count of participants · Participants
Percentage of Individual Responders
ParticipantsTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Percentage of Individual Responders383
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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:
1 month
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.69 ± 2.17-0.36 ± 1.46
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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:
3 months
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.77 ± 2.04-0.40 ± 1.74
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.76 ± 2.070.13 ± 1.55
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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:
9 months
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.43 ± 2.13-0.07 ± 0.59
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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:
12 months
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.42 ± 2.23-0.10 ± 0.42
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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:
18 months
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.52 ± 1.93-0.16 ± 0.73
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001
SecondaryChange From Baseline in Visual Analog Scale (VAS) Back Pain Score

Change from Baseline in Back Pain 10 cm VAS = Follow-up Visit Pain VAS - Baseline Pain VAS. A negative result reflects a decrease in the Pain VAS, while a positive result reflects an increase in Pain VAS. 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:
24 months
Reported as:
Mean · cm
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score
cmTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) Alone
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score-5.98 ± 1.68-0.22 ± 0.95
Statistical analysis
  • Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) vs Control Group - Conventional Medical Management (CMM) Alone · Chi-squared · p = <0.0001

Adverse events

Collected over From enrollment through the completion of the study (up to 24 months follow-up). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)0/55 (0%)15/55 (27.3%)29/55 (52.7%)
Control Group - Conventional Medical Management (CMM) Alone0/57 (0%)3/57 (5.3%)6/57 (10.5%)
Optional Crossover at 6 Month0/50 (0%)10/50 (20%)21/50 (42%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneOptional Crossover at 6 Month
OsteoarthritisMusculoskeletal and connective tissue disorders0/550/572/50
Postoperative wound infectionInfections and infestations2/550/571/50
Post procedural infectionInfections and infestations1/550/571/50
Jaw fractureInjury, poisoning and procedural complications0/550/571/50
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/550/571/50
Meningitis viralInfections and infestations0/550/571/50
Motor dysfunctionNervous system disorders0/550/571/50
Myocardial infarctionCardiac disorders0/550/571/50
Pneumonia influenzalInfections and infestations0/550/571/50
Procedural headacheInjury, poisoning and procedural complications0/550/571/50
Most frequent other events
Most frequent other events
EventTest Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneOptional Crossover at 6 Month
COVID-19Infections and infestations14/553/5714/50
ArthralgiaMusculoskeletal and connective tissue disorders4/551/574/50
Wound complicationInjury, poisoning and procedural complications4/550/572/50
HypercholesterolaemiaMetabolism and nutrition disorders2/550/573/50
DepressionPsychiatric disorders3/550/570/50
Back painMusculoskeletal and connective tissue disorders3/552/572/50
FallInjury, poisoning and procedural complications3/550/570/50
Implant site painGeneral disorders3/550/572/50
OsteoarthritisMusculoskeletal and connective tissue disorders3/550/570/50
Postoperative wound infectionInfections and infestations3/550/570/50

Baseline characteristics

Baseline analysis population included Modified Intent to Treat (mITT) population, defined as all successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm.

Age, Continuous
Age, Continuous(years)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Mean55.86 ± 13.0156.86 ± 12.8156.39 ± 12.86
Sex: Female, Male
Sex: Female, Male(Participants)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Female292857
Male222951
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Netherlands141630
Belgium182341
Germany336
Spain161531
Years with Chronic Low Back Pain (CLBP), Continuous
Years with Chronic Low Back Pain (CLBP), Continuous(years)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Mean10.4 ± 10.911.6 ± 10.811.0 ± 10.8
Body Mass Index (BMI), Continuous
Body Mass Index (BMI), Continuous(kg/m²)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Mean27.54 ± 4.5027.81 ± 4.4227.68 ± 4.44
Baseline Back Pain Visual Analog Scale (VAS), Continuous
Baseline Back Pain Visual Analog Scale (VAS), Continuous(cm)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Mean7.91 ± 0.977.76 ± 1.037.83 ± 1.00
Pain Diagnosis
Pain Diagnosis(Participants)Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)Control Group - Conventional Medical Management (CMM) AloneTotal
Chronic intractable back pain5157108
Chronic intractable leg pain435093
08

Study locations

12 sites
  • 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
  • Hospital Universitario Virgen del Rocío
    Sevilla, Spain
  • Hospital Clínico Universitario de Valencia
    Valencia, Spain
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06442410
Lead sponsor
MedtronicNeuro
Collaborators
SGX Group
Responsible party
Sponsor
First posted
Jun 4, 2024
Start date
Jul 24, 2020
Primary completion
May 9, 2022
Completion
Oct 17, 2023
Results posted
Nov 7, 2024
Last update
Nov 7, 2024

Study contacts

Mirit Argov
study director · Medtronic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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