Trial Outcomes & Findings for Spinal Cord Stimulation for Predominant Low Back Pain (NCT NCT01697358)
NCT ID: NCT01697358
Last Updated: 2017-07-21
Results Overview
Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.
COMPLETED
PHASE4
278 participants
6 months post randomization
2017-07-21
Participant Flow
A total of 278 subjects were recruited between January 2013 and August 2015 from 28 sites in Canada, Colombia, Europe, and US.
A total of 60 subjects didn't meet the inclusion and/or exclusion criteria and discontinued from the study before randomization.
Participant milestones
| Measure |
SCS + OMM
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Period I: Randomization to 6 Months
STARTED
|
110
|
108
|
|
Period I: Randomization to 6 Months
COMPLETED
|
97
|
107
|
|
Period I: Randomization to 6 Months
NOT COMPLETED
|
13
|
1
|
|
Period II: 6-24M Long-term Follow-up
STARTED
|
97
|
107
|
|
Period II: 6-24M Long-term Follow-up
COMPLETED
|
48
|
52
|
|
Period II: 6-24M Long-term Follow-up
NOT COMPLETED
|
49
|
55
|
Reasons for withdrawal
| Measure |
SCS + OMM
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Period I: Randomization to 6 Months
Withdrawal by Subject
|
6
|
0
|
|
Period I: Randomization to 6 Months
Physician Decision
|
4
|
0
|
|
Period I: Randomization to 6 Months
Adverse Event
|
1
|
1
|
|
Period I: Randomization to 6 Months
Lost to Follow-up
|
2
|
0
|
|
Period II: 6-24M Long-term Follow-up
Physician Decision
|
3
|
12
|
|
Period II: 6-24M Long-term Follow-up
Withdrawal by Subject
|
8
|
10
|
|
Period II: 6-24M Long-term Follow-up
Lost to Follow-up
|
3
|
3
|
|
Period II: 6-24M Long-term Follow-up
Death
|
1
|
1
|
|
Period II: 6-24M Long-term Follow-up
Adverse Event
|
0
|
3
|
|
Period II: 6-24M Long-term Follow-up
Active subjects at the time of posting
|
34
|
26
|
Baseline Characteristics
Spinal Cord Stimulation for Predominant Low Back Pain
Baseline characteristics by cohort
| Measure |
SCS + OMM
n=110 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
55.1 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
53.9 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post randomizationPopulation: Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as non-responders.
Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.
Outcome measures
| Measure |
SCS + OMM
n=110 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.
Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.
Outcome measures
| Measure |
SCS + OMM
n=110 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups
|
1.4 units on a scale
Standard Deviation 1.9
|
0.3 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.
Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.
Outcome measures
| Measure |
SCS + OMM
n=110 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups
|
1.2 units on a scale
Standard Deviation 2.1
|
-0.1 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.
ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.
Outcome measures
| Measure |
SCS + OMM
n=110 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups
|
8.1 units on a scale
Standard Deviation 14.7
|
1.8 units on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.
The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.
Outcome measures
| Measure |
SCS + OMM
n=110 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups
|
5.27 units on a scale
Standard Deviation 8.28
|
1.34 units on a scale
Standard Deviation 6.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post randomizationPopulation: As-treated - included all randomized subjects who provided data at 6-month visit, and analyzed based on the actual treatment the subjects received at 6-month visit.
This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.
Outcome measures
| Measure |
SCS + OMM
n=79 Participants
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=117 Participants
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups
|
31 Participants
|
14 Participants
|
Adverse Events
SCS + OMM
OMM Alone
Serious adverse events
| Measure |
SCS + OMM
n=110 participants at risk
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 participants at risk
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
|
|---|---|---|
|
Infections and infestations
Implant site infection
|
5.5%
6/110 • Number of events 7 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Psychiatric disorders
Drug abuse
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Cardiac disorders
Cardiac disorder
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
General disorders
Implant site pain
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.91%
1/110 • Number of events 1 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Product Issues
Device extrusion
|
0.00%
0/110 • Randomization to 6 months
|
0.93%
1/108 • Number of events 1 • Randomization to 6 months
|
|
Product Issues
Device stimulation issue
|
1.8%
2/110 • Number of events 2 • Randomization to 6 months
|
0.00%
0/108 • Randomization to 6 months
|
Other adverse events
| Measure |
SCS + OMM
n=110 participants at risk
Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
|
OMM Alone
n=108 participants at risk
Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects' pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject's original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
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General disorders
Adverse drug reaction
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1.8%
2/110 • Number of events 2 • Randomization to 6 months
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3.7%
4/108 • Number of events 4 • Randomization to 6 months
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Injury, poisoning and procedural complications
Fall
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1.8%
2/110 • Number of events 3 • Randomization to 6 months
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6.5%
7/108 • Number of events 7 • Randomization to 6 months
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Additional Information
Restorative Therapies Group Clinical Trials
Medtronic Restorative Therapies Group - Pain Stim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place