Pain, Intractable, Pain, Chronic
Conditions
Brief summary
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.
Interventions
DEVICEDTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system
Along with the appropriate Conventional Medical Management treatment made by the Investigator, the subject will be trialed and implanted with an Intellis™ neurostimulator system using DTM™ SCS programming parameters.
The CMM treatment can be modified at any moment by the investigators based on their clinical evaluation and local standard of care. They may also consists of one or more of the following treatments: medications, combined physical and psychological management, physical therapy, back rehabilitation program, spinal manipulation and spinal mobilization, traction, acupuncture, cognitive behavioral therapy, biofeedback, nerve blocks, radio frequency ablation, epidural steroid injections, transcutaneous electrical nerve stimulation, intradiscal electrothermal therapy, nucleoplasty, also called plasma disc decompression (PDD) or similar
Sponsors
SGX Group
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * DTM™ SCS programming approach with Conventional Medical Management (CMM) * CMM alone There is an optional two-way crossover to the other treatment group available for all subjects who remain in the study at the 6-months visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Individual Responders | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Individual Responders | 1 month | 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. |
| Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | 1 month | 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. |
Countries
Belgium, Germany, Netherlands, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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 |
| Total | 108 |
Baseline characteristics
| Characteristic | Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Control Group - Conventional Medical Management (CMM) Alone | Total |
|---|---|---|---|
| Age, Continuous | 55.86 years STANDARD_DEVIATION 13.01 | 56.86 years STANDARD_DEVIATION 12.81 | 56.39 years STANDARD_DEVIATION 12.86 |
| Baseline Back Pain Visual Analog Scale (VAS), Continuous | 7.91 cm STANDARD_DEVIATION 0.97 | 7.76 cm STANDARD_DEVIATION 1.03 | 7.83 cm STANDARD_DEVIATION 1 |
| Body Mass Index (BMI), Continuous | 27.54 kg/m² STANDARD_DEVIATION 4.5 | 27.81 kg/m² STANDARD_DEVIATION 4.42 | 27.68 kg/m² STANDARD_DEVIATION 4.44 |
| Pain Diagnosis Chronic intractable back pain | 51 Participants | 57 Participants | 108 Participants |
| Pain Diagnosis Chronic intractable leg pain | 43 Participants | 50 Participants | 93 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Belgium | 18 participants | 23 participants | 41 participants |
| Region of Enrollment Germany | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Netherlands | 14 participants | 16 participants | 30 participants |
| Region of Enrollment Spain | 16 participants | 15 participants | 31 participants |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 22 Participants | 29 Participants | 51 Participants |
| Years with Chronic Low Back Pain (CLBP), Continuous | 10.4 years STANDARD_DEVIATION 10.9 | 11.6 years STANDARD_DEVIATION 10.8 | 11.0 years STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 57 | 0 / 50 |
| other Total, other adverse events | 29 / 55 | 6 / 57 | 21 / 50 |
| serious Total, serious adverse events | 15 / 55 | 3 / 57 | 10 / 50 |
Outcome results
Primary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 6 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 40 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 2 Participants |
p-value: <0.0001Chi-squared
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.
Time frame: 24 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, carrying forward the baseline (pre-treatment) scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.98 cm | Standard Deviation 1.68 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -0.22 cm | Standard Deviation 0.95 |
p-value: <0.0001Chi-squared
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.69 cm | Standard Deviation 2.17 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -0.36 cm | Standard Deviation 1.46 |
p-value: <0.0001Chi-squared
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.77 cm | Standard Deviation 2.04 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -0.40 cm | Standard Deviation 1.74 |
p-value: <0.0001Chi-squared
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.76 cm | Standard Deviation 2.07 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | 0.13 cm | Standard Deviation 1.55 |
p-value: <0.0001Chi-squared
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.
Time frame: 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, carrying forward the baseline (pre-treatment) scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.43 cm | Standard Deviation 2.13 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -0.07 cm | Standard Deviation 0.59 |
p-value: <0.0001Chi-squared
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.
Time frame: 12 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, carrying forward the baseline (pre-treatment) scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.42 cm | Standard Deviation 2.23 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -0.10 cm | Standard Deviation 0.42 |
p-value: <0.0001Chi-squared
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.
Time frame: 18 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, carrying forward the baseline (pre-treatment) scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -5.52 cm | Standard Deviation 1.93 |
| Control Group - Conventional Medical Management (CMM) Alone | Change From Baseline in Visual Analog Scale (VAS) Back Pain Score | -0.16 cm | Standard Deviation 0.73 |
p-value: <0.0001Chi-squared
Secondary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 3 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 41 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 3 Participants |
p-value: <0.0001Chi-squared
Secondary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 9 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 37 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 0 Participants |
p-value: <0.0001Chi-squared
Secondary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 12 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 36 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 0 Participants |
p-value: <0.0001Chi-squared
Secondary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 18 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 37 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 1 Participants |
p-value: <0.0001Chi-squared
Secondary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 24 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 38 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 3 Participants |
Secondary
Percentage of Individual Responders
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 1 month
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group - DTM™ SCS Programming Approach With Conventional Medical Management (CMM) | Percentage of Individual Responders | 41 Participants |
| Control Group - Conventional Medical Management (CMM) Alone | Percentage of Individual Responders | 1 Participants |
p-value: <0.0001Chi-squared