Trial Outcomes & Findings for 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 (NCT NCT06442410)

Last Updated: 2024-11-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

6 months

Results posted on

2024-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Non-Crossover STARTED	55	57
Overall Non-Crossover COMPLETED	40	4
Overall Non-Crossover NOT COMPLETED	15	53
Optional Crossover at 6 Month STARTED	0	50
Optional Crossover at 6 Month COMPLETED	0	39
Optional Crossover at 6 Month NOT COMPLETED	0	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=51 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=57 Participants 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).	Total n=108 Participants Total of all reporting groups
Age, Continuous	55.86 years STANDARD_DEVIATION 13.01 • n=51 Participants	56.86 years STANDARD_DEVIATION 12.81 • n=57 Participants	56.39 years STANDARD_DEVIATION 12.86 • n=108 Participants
Sex: Female, Male Female	29 Participants n=51 Participants	28 Participants n=57 Participants	57 Participants n=108 Participants
Sex: Female, Male Male	22 Participants n=51 Participants	29 Participants n=57 Participants	51 Participants n=108 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	14 participants n=51 Participants	16 participants n=57 Participants	30 participants n=108 Participants
Region of Enrollment Belgium	18 participants n=51 Participants	23 participants n=57 Participants	41 participants n=108 Participants
Region of Enrollment Germany	3 participants n=51 Participants	3 participants n=57 Participants	6 participants n=108 Participants
Region of Enrollment Spain	16 participants n=51 Participants	15 participants n=57 Participants	31 participants n=108 Participants
Years with Chronic Low Back Pain (CLBP), Continuous	10.4 years STANDARD_DEVIATION 10.9 • n=51 Participants	11.6 years STANDARD_DEVIATION 10.8 • n=57 Participants	11.0 years STANDARD_DEVIATION 10.8 • n=108 Participants
Body Mass Index (BMI), Continuous	27.54 kg/m² STANDARD_DEVIATION 4.50 • n=51 Participants	27.81 kg/m² STANDARD_DEVIATION 4.42 • n=57 Participants	27.68 kg/m² STANDARD_DEVIATION 4.44 • n=108 Participants
Baseline Back Pain Visual Analog Scale (VAS), Continuous	7.91 cm STANDARD_DEVIATION 0.97 • n=51 Participants	7.76 cm STANDARD_DEVIATION 1.03 • n=57 Participants	7.83 cm STANDARD_DEVIATION 1.00 • n=108 Participants
Pain Diagnosis Chronic intractable back pain	51 Participants n=51 Participants	57 Participants n=57 Participants	108 Participants n=108 Participants
Pain Diagnosis Chronic intractable leg pain	43 Participants n=51 Participants	50 Participants n=57 Participants	93 Participants n=108 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=47 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=56 Participants 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).
Percentage of Individual Responders	40 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 month

Population: 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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=49 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=57 Participants 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).
Percentage of Individual Responders	41 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=48 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=56 Participants 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).
Percentage of Individual Responders	41 Participants	3 Participants

SECONDARY outcome

Timeframe: 9 months

Population: 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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=45 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=56 Participants 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).
Percentage of Individual Responders	37 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=45 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=55 Participants 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).
Percentage of Individual Responders	36 Participants	0 Participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=45 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=55 Participants 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).
Percentage of Individual Responders	37 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=43 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=55 Participants 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).
Percentage of Individual Responders	38 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 month

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=49 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=57 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.69 cm Standard Deviation 2.17	-0.36 cm Standard Deviation 1.46

SECONDARY outcome

Timeframe: 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=48 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=56 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.77 cm Standard Deviation 2.04	-0.40 cm Standard Deviation 1.74

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=47 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=56 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.76 cm Standard Deviation 2.07	0.13 cm Standard Deviation 1.55

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=45 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=56 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.43 cm Standard Deviation 2.13	-0.07 cm Standard Deviation 0.59

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=45 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=55 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.42 cm Standard Deviation 2.23	-0.10 cm Standard Deviation 0.42

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=45 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=55 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.52 cm Standard Deviation 1.93	-0.16 cm Standard Deviation 0.73

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=43 Participants 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.	Control Group - Conventional Medical Management (CMM) Alone n=55 Participants 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).
Change From Baseline in Visual Analog Scale (VAS) Back Pain Score	-5.98 cm Standard Deviation 1.68	-0.22 cm Standard Deviation 0.95

Adverse Events

Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM)

Serious events: 15 serious events

Other events: 29 other events

Deaths: 0 deaths

Control Group - Conventional Medical Management (CMM) Alone

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Optional Crossover at 6 Month

Serious events: 10 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) n=55 participants at risk 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.	Control Group - Conventional Medical Management (CMM) Alone n=57 participants at risk 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).	Optional Crossover at 6 Month n=50 participants at risk Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit.
Infections and infestations COVID-19	25.5% 14/55 • Number of events 14 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	5.3% 3/57 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	28.0% 14/50 • Number of events 14 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	3.6% 2/55 • Number of events 2 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	6.0% 3/50 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Musculoskeletal and connective tissue disorders Arthralgia	7.3% 4/55 • Number of events 5 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	1.8% 1/57 • Number of events 1 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	8.0% 4/50 • Number of events 4 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Psychiatric disorders Depression	5.5% 3/55 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/50 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Musculoskeletal and connective tissue disorders Back pain	5.5% 3/55 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	3.5% 2/57 • Number of events 2 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	4.0% 2/50 • Number of events 2 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Injury, poisoning and procedural complications Fall	5.5% 3/55 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/50 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
General disorders Implant site pain	5.5% 3/55 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	4.0% 2/50 • Number of events 2 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.5% 3/55 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/50 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Infections and infestations Postoperative wound infection	5.5% 3/55 • Number of events 3 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/50 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.
Injury, poisoning and procedural complications Wound complication	7.3% 4/55 • Number of events 4 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	0.00% 0/57 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.	4.0% 2/50 • Number of events 2 • From enrollment through the completion of the study (up to 24 months follow-up) Adverse events were captured from enrollment through the completion of the study (up to 24 months follow-up). As the primary efficacy measure in this study is pain, back or leg pain does not need to be reported as an adverse event unless it meets the definition of a serious adverse event. However, Investigators may, at their discretion, report any pain-related adverse events during the study.

Additional Information

Thanh Tran

Medtronic

Phone: 7278082652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60