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| ID | Type | Description | Link |
|---|---|---|---|
| G120146 | Other Identifier | FDA Protocol Number |
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Sponsor decision
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The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant |
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| Control | Other | Control settings of Medtronic PrimeAdvanced® neurostimulator system implant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrimeAdvanced® neurostimulator system | Device | Neurostimulator and associated components |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation. | Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders. | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Disability | Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Mandybur, MD | Mayfield Clinic, University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Pain Consultants | Phoenix | Arizona | 85001 | United States | ||
| HOPE Research Institute |
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Of the 137 enrolled subjects, 62 were implanted and randomized. Of the 75 subjects who discontinued from the study prior to randomization, 54 did not meet inclusion/exclusion criteria, 12 withdrew consent or declined device implant, 3 discontinued due to study suspension, and 6 discontinued for other reasons.
This study enrolled adult patients with chronic, intractable post-surgical back pain. First enrollment was in April 2013. Enrollment was suspended in September 2014 due to slow enrollment. The last subject visit was in March 2016. The planned enrollment was 323 subjects, with 218 randomized. Actual enrollment was 137 subjects with 62 randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant PrimeAdvanced® neurostimulator system: Neurostimulator and associated components |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Phase (Randomization - 3 Months) |
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| Baseline to 3 months |
| Subject Satisfaction | Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis. | 3 months |
| Quality of Life: Physical | Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0). | Baseline to 3 months |
| Quality of Life: Mental | Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0). | Baseline to 3 months |
| Worst Back Pain | Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain. | Baseline to 3 months |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Coastal Pain Research | Carlsbad | California | 92009 | United States |
| Pain Medicine Associates | Fountain Valley | California | 92708 | United States |
| Florida Pain Institute | Merritt Island | Florida | 32953 | United States |
| Advanced Medicine and Pain Management Research | Miami | Florida | 33145 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Willis Knighton River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| Comprehensive Pain and Rehabilitation | Pascagoula | Mississippi | 39581 | United States |
| Columbia Interventional Pain Center, LLP | Columbia | Missouri | 65201 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65804 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Mayfield Clinic | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Summa Western Reserve Hospital | Cuyahoga Falls | Ohio | 44223 | United States |
| DNA Advanced Pain Treatment Center | Greensburg | Pennsylvania | 15601 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Southern Spine Institute | Mt. Pleasant | South Carolina | 29464 | United States |
| Austin Pain Associates | Cedar Park | Texas | 78613 | United States |
| Space City Pain Specialists | Webster | Texas | 77598 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Wisconsin Health Center Surgery Center | Greenfield | Wisconsin | 53220 | United States |
Control settings of Medtronic PrimeAdvanced® neurostimulator system implant
PrimeAdvanced® neurostimulator system: Neurostimulator and associated components
| Week 1 |
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| Week 6 |
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| COMPLETED |
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| NOT COMPLETED |
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| Open Label Phase (3-12 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant PrimeAdvanced® neurostimulator system: Neurostimulator and associated components |
| BG001 | Control | Control settings of Medtronic PrimeAdvanced® neurostimulator system implant PrimeAdvanced® neurostimulator system: Neurostimulator and associated components |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Back pain | Average/typical back pain on a scale of 0 (no pain) - 10 (worst pain). Average of a back pain diary assessment. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation. | Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders. | Posted | Count of Participants | Participants | Baseline to 3 months |
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| Secondary | Functional Disability | Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months |
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| Secondary | Subject Satisfaction | Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis. | The analysis population includes all randomized subjects, with the exception of one subject in the Control group who did not have a satisfaction value. This subject was excluded from the analysis. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Quality of Life: Physical | Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months |
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| Secondary | Quality of Life: Mental | Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0). | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months |
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| Secondary | Worst Back Pain | Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months |
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The adverse events summarized by treatment arm are all adverse events that were collected during the Blinded Phase of the study (from Randomization through the Month 3 visit).
There were 175.6 total months of subject follow-up during this time: 94.2 months in the Treatment group and 81.4 months in the Control group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant PrimeAdvanced® neurostimulator system: Neurostimulator and associated components | 0 | 32 | 2 | 32 | 11 | 32 |
| EG001 | Control | Control settings of Medtronic PrimeAdvanced® neurostimulator system implant PrimeAdvanced® neurostimulator system: Neurostimulator and associated components | 0 | 30 | 0 | 30 | 8 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Implant site pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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Due to early study termination prior to completion of planned enrollment, the summaries describe the available data, and no conclusions can be made on the efficacy of the therapy based on the data available.
Disclosure restrictions on the PI allow for the sponsor to review results communications prior to public release and to embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to sponsor for review. The sponsor is also allowed to require changes for technical correctness and to protect confidential information, copyrightable or patentable material; and when reasonably requested, extend the embargo up to an additional 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neuro Clinical Trials | Medtronic Neuromodulation | medtronicneurotrials@medtronic.com |
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| C000711512 | post laminectomy syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group. |
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