Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Seacroft Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
The primary purpose of this study is to compare the therapeutic efficacy of the conventional, paresthesia mapping-based burst spinal cord stimulation (SCS) implantation strategy to a more novel, anatomic midline-based approach that has the potential to streamline the workflow associated with the SCS treatment continuum.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomical midline lead first | Experimental | subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead |
|
| Paresthesia mapping lead first | Experimental | subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paresthesia mapping lead evaluation first | Device | Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Back Pain at SCS Trial | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | after 2 weeks of SCS trial |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for Back Pain at 3 Months | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | 3 months after activation of permanent SCS implant |
| Visual Analog Scale (VAS) for Back Pain at 6 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lalit Venkatesan, Ph.D. | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seacroft Hospital | Leeds | Yorkshire and the Humber | LS14 6UH | United Kingdom | ||
| St. Thomas Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
55 of 60 subjects were randomized. Of those not randomized 3 did not meet inclusion criteria, 1 withdrew consent and 1 was withdrawn by the investigator because his diabetes become uncontrolled increasing the risk associated with SCS implant
60 patients were enrolled and screened for eligibility between October 2016 and June 2018 in hospitals in London and Leeds U.K.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Anatomical Positioning Lead First | subjects in this group will receive stimulation first using an anatomical midline placed lead and subsequently using a paresthesia mapping placed lead Anatomical midline lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial |
| FG001 | Paresthesia Mapping Lead First | subjects in this group will receive stimulation first using a paresthesia mapping placed lead and subsequently using an anatomical midline placed lead Paresthesia mapping lead evaluation first: Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial |
| FG002 | Follow up Using Paresthesia Mapping Lead Stimulation | Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the paresthesia mapping approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the paresthesia mapping approach |
| FG003 | Follow up Using Anatomical Placement Lead Stimulation | Subjects that were successful at SCS trial, expressed preference for stimulation delivered using the lead implanted with the anatomical positioning approach and received permanent implant, were followed up for 12 months while receiving stimulation delivered using the lead implanted with the anatomical positioning approach |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Trial Period |
|
| ||||||||||||||||||
| Second Trial Period |
| |||||||||||||||||||
| Follow up Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who were enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Analog Scale (VAS) for Back Pain at SCS Trial | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | after 2 weeks of SCS trial |
|
|
Through completion of the study, on average about 1 year
Adverse events in this study were not collected per intervention as there were no primary safety endpoints and no investigational devices used in this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anatomically Positioned Leads and Parasthesia Mapped Leads | All subjects enrolled in the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain due to gall stones | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IPG pain | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yagna Pathak | Abbott | +1-469-243-0088 | yagna.pathak@abbott.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2016 | Jul 9, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Anatomical midline lead evaluation first | Device | Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial |
|
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| 6 months after activation of permanent SCS implant |
| Visual Analog Scale (VAS) for Back Pain at 12 Months | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | 12 months after activation of permanent SCS implant |
| EQ-5D at SCS Trial | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | after 2 weeks of SCS trial |
| EQ-5D at 3 Month | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | 3 months after activation of permanent SCS implant |
| EQ-5D at 6 Month | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | 6 months after activation of permanent SCS implant |
| EQ-5D at 12 Month | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | 12 months after activation of permanent SCS implant |
| ODI at SCS Trial | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | first SCS trial assessment (up to two weeks after electrodes implantation) |
| ODI at 3 Months | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | 3 months after activation of permanent SCS implant |
| ODI at 6 Months | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | 6 months after activation of permanent SCS implant |
| ODI at 12 Months | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | 12 months after activation of permanent SCS implant |
| Satisfaction Questionnaire | questionnaire regarding patient satisfaction with the therapy | 3 month follow up |
| Satisfaction Questionnaire | questionnaire regarding patient satisfaction with the therapy | 6 month follow up |
| Satisfaction Questionnaire | questionnaire regarding patient satisfaction with the therapy | 12 month follow up |
| London |
| SE1 7EH |
| United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
| 3 Month Follow up |
|
| 6 Month Follow up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Gender was not reported for two subjects | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Visual Analog Scale (VAS) for Back Pain at 3 Months | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | one in the paresthesia mapping lead group had missing data | Posted | Mean | Standard Deviation | units on a scale | 3 months after activation of permanent SCS implant |
|
|
|
| Secondary | Visual Analog Scale (VAS) for Back Pain at 6 Months | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group | Posted | Mean | Standard Deviation | units on a scale | 6 months after activation of permanent SCS implant |
|
|
|
| Secondary | Visual Analog Scale (VAS) for Back Pain at 12 Months | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | 12 months after activation of permanent SCS implant |
|
|
|
| Secondary | EQ-5D at SCS Trial | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Data missing for one patient in the anatomically positioned lead group and one patient for the paresthesia mapping lead group | Posted | Mean | Standard Deviation | score on a scale | after 2 weeks of SCS trial |
|
|
|
| Secondary | EQ-5D at 3 Month | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group | Posted | Mean | Standard Deviation | score on a scale | 3 months after activation of permanent SCS implant |
|
|
|
| Secondary | EQ-5D at 6 Month | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | One patient had missing data in the anatomically positioned lead group | Posted | Mean | Standard Deviation | score on a scale | 6 months after activation of permanent SCS implant |
|
|
|
| Secondary | EQ-5D at 12 Month | Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life) | Posted | Mean | Standard Deviation | score on a scale | 12 months after activation of permanent SCS implant |
|
|
|
| Secondary | ODI at SCS Trial | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Posted | Mean | Standard Deviation | score on a scale | first SCS trial assessment (up to two weeks after electrodes implantation) |
|
|
|
| Secondary | ODI at 3 Months | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Posted | Mean | Standard Deviation | score on a scale | 3 months after activation of permanent SCS implant |
|
|
|
| Secondary | ODI at 6 Months | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | One patient had missing data in the anatomically positioned lead group | Posted | Mean | Standard Deviation | score on a scale | 6 months after activation of permanent SCS implant |
|
|
|
| Secondary | ODI at 12 Months | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) | Posted | Mean | Standard Deviation | score on a scale | 12 months after activation of permanent SCS implant |
|
|
|
| Secondary | Satisfaction Questionnaire | questionnaire regarding patient satisfaction with the therapy | One patient had missing data in the paresthesia mapping lead group | Posted | Count of Participants | Participants | 3 month follow up |
|
|
|
| Secondary | Satisfaction Questionnaire | questionnaire regarding patient satisfaction with the therapy | four patients had missing data in the anatomically positioned lead group | Posted | Count of Participants | Participants | 6 month follow up |
|
|
|
| Secondary | Satisfaction Questionnaire | questionnaire regarding patient satisfaction with the therapy | One patient had missing data in the anatomically positioned lead group | Posted | Count of Participants | Participants | 12 month follow up |
|
|
|
| 0 |
| 55 |
| 6 |
| 55 |
| 5 |
| 55 |
| difficulty urination and inability to weight bear on right leg | General disorders | Non-systematic Assessment |
|
| right leg numbness | General disorders | Non-systematic Assessment |
|
| worsening of pain | General disorders | Non-systematic Assessment |
|
| photophobia | General disorders | Non-systematic Assessment |
|
| wound exploration | Surgical and medical procedures | Non-systematic Assessment |
|
| system explant due to suspicion of infection | Infections and infestations | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| neither satisfied or dissatisfied |
|
| satisfied |
|
| very satisfied |
|
| neither satisfied nor dissatisfied |
|
| satisfied |
|
| very satisfied |
|
| neither satisfied nor dissatisfied |
|
| satisfied |
|
| very satisfied |
|