Comparison of DTM™ SCS Therapy Combined With Conventional... | NCT06442410

NCT06442410

ID	Type	Description	Link
ISRCTN10663814	Registry Identifier	ISRCTN Registry

Status Module

Sponsor/Collaborators Module

Name	Class
SGX Group	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	1 month

Eligibility Module

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.)

Contacts/Locations Module

Name	Affiliation	Role
Mirit Argov	Medtronic	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
AZ Delta		Roeselare			Belgium
AZ Nikolaas

References Module

Label	URL
ISRCTN Registry posting	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 21, 2020	Sep 3, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

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.

Arm/Group Information

ID	Title	Description
BG000	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). 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.
BG001	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).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00040 OG0012

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		<0.0001														Superiority

Secondary

Percentage of Individual Responders

Modified Intent to Treat (mITT): All successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm.

Posted

Count of Participants

Participants

1 month

ID	Title	Description
OG000	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). 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.

Secondary

Percentage of Individual Responders

Modified Intent to Treat (mITT): All successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	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). 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.

Secondary

Percentage of Individual Responders

Modified Intent to Treat (mITT): All successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm. Crossover subjects were counted as failures (i.e. non-responders) for endpoints defined in terms of responders in their group of original randomization assignment.

Posted

Count of Participants

Participants

9 months

ID	Title	Description
OG000	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). 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.

Secondary

Percentage of Individual Responders

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	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). 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.

Secondary

Percentage of Individual Responders

Posted

Count of Participants

Participants

18 months

ID	Title	Description
OG000	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). 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.

Secondary

Percentage of Individual Responders

Posted

Count of Participants

Participants

24 months

ID	Title	Description
OG000	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). 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.

Secondary

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.

Modified Intent to Treat (mITT): All successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm.

Posted

Mean

Standard Deviation

1 month

ID	Title	Description
OG000	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). 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.

Secondary

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

Modified Intent to Treat (mITT): All successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm.

Posted

Mean

Standard Deviation

3 months

ID	Title	Description
OG000	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). 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.

Secondary

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

Modified Intent to Treat (mITT): All successfully randomized subjects to the test arm who completed the Trial Phase and all successfully randomized subjects to the control arm.

Posted

Mean

Standard Deviation

6 months

ID	Title	Description
OG000	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). 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.

Secondary

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

Posted

Mean

Standard Deviation

9 months

ID	Title	Description
OG000	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). 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.

Secondary

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

Posted

Mean

Standard Deviation

12 months

ID	Title	Description
OG000	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). 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.

Secondary

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

Posted

Mean

Standard Deviation

18 months

ID	Title	Description
OG000	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). 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.

Secondary

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

Posted

Mean

Standard Deviation

24 months

ID	Title	Description
OG000	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). 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.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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). 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.	55	15	55	29	55
EG001	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).	57	3	57	6	57
EG002	Optional Crossover at 6 Month	Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit.	50	10	50	21	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Alcoholism	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Postoperative wound infection	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Drug-induced liver inquiry	Hepatobiliary disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Gastric bypass	Surgical and medical procedures	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Pneumonia	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Dizziness	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Post procedural infection	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Adhesiolysis	Surgical and medical procedures	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected57 at risk EG0020 events0 affected50 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected57 at risk EG0020 events0 affected50 at risk
COVID-19	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected57 at risk EG0020 events0 affected50 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Meningitis viral	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Motor dysfunction	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Myocardial infarction	Cardiac disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0022 events2 affected50 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Procedural headache	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk
Vestibular neuronitis	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected57 at risk EG0021 events1 affected50 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA (23.1, 24.0)	Systematic Assessment	EG00014 events14 affected55 at risk EG0013 events3 affected57 at risk EG00214 events14 affected50 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected57 at risk EG0023 events3 affected50 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0005 events4 affected55 at risk EG0011 events1 affected57 at risk EG0024 events4 affected50 at risk
Depression	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1, 24.0)	Systematic Assessment	EG0003 events3 affected55 at risk EG0012 events2 affected57 at risk EG0022 events2 affected50 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (24.0)	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Implant site pain	General disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected57 at risk EG0022 events2 affected50 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Postoperative wound infection	Infections and infestations	MedDRA (23.1, 24.0)	Systematic Assessment	EG0003 events3 affected55 at risk EG0010 events0 affected57 at risk EG0020 events0 affected50 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA (23.1, 24.0)	Systematic Assessment	EG0004 events4 affected55 at risk EG0010 events0 affected57 at risk EG0022 events2 affected50 at risk

First MCP Posted Date

ID	Term
D010148	Pain, Intractable
D059350	Chronic Pain

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms