Chronic Pain
Conditions
Brief summary
The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.
Detailed description
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.
Interventions
DEVICEParesthesia 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
DEVICEAnatomical 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
Sponsors
Abbott Medical Devices
Guy's and St Thomas' NHS Foundation Trust
Seacroft Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to provide informed consent to participate in the study; * Subject is 18 years of age or older; * Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy as per NICE Tag 0159; * FBSS subjects with predominant low back pain; * Subject has a lower back pain intensity of at least 6.0 out of 10.0 on the VAS at baseline; * Subject is on stable pain medications with a total opioid equivalent of 120 mgs a day or less for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device; * Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system; * Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; * Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study
Exclusion criteria
* Subjects with significant scoliosis even if surgically corrected * Subject is currently participating in a clinical investigation that includes an active treatment arm; * Subject has been implanted with or participated in a trial period for a neurostimulation system; * Subject has an infusion pump; * Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care; * Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus; * Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator; * Subject is immunocompromised; * Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor); * Subject has history of cancer requiring active treatment in the last 12 months; * Subject has an existing medical condition that is likely to require the use of diathermy in the future; * Subject has documented history of allergic response to titanium or silicone; * Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection; * Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Back Pain at SCS Trial | after 2 weeks of SCS trial | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Back Pain at 3 Months | 3 months after activation of permanent SCS implant | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Visual Analog Scale (VAS) for Back Pain at 6 Months | 6 months after activation of permanent SCS implant | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| Visual Analog Scale (VAS) for Back Pain at 12 Months | 12 months after activation of permanent SCS implant | Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable) |
| EQ-5D at SCS Trial | after 2 weeks of 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) |
| EQ-5D at 3 Month | 3 months after activation of permanent SCS implant | 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) |
| EQ-5D at 6 Month | 6 months after activation of permanent SCS implant | 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) |
| EQ-5D at 12 Month | 12 months after activation of permanent SCS implant | 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) |
| ODI at SCS Trial | first SCS trial assessment (up to two weeks after electrodes implantation) | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| ODI at 3 Months | 3 months after activation of permanent SCS implant | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| ODI at 6 Months | 6 months after activation of permanent SCS implant | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| ODI at 12 Months | 12 months after activation of permanent SCS implant | questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability) |
| Satisfaction Questionnaire | 3 month follow up | questionnaire regarding patient satisfaction with the therapy |
Countries
United Kingdom
Contacts
STUDY_DIRECTORLalit Venkatesan, Ph.D.
Abbott Medical Devices
Participant flow
Recruitment details
60 patients were enrolled and screened for eligibility between October 2016 and June 2018 in hospitals in London and Leeds U.K.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who were enrolled in the study | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United Kingdom | 55 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 5 / 55 |
| serious Total, serious adverse events | 6 / 55 |
Outcome results
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)
Time frame: after 2 weeks of SCS trial
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | Visual Analog Scale (VAS) for Back Pain at SCS Trial | 32 units on a scale | Standard Deviation 25.9 |
| Paresthesia Mapping Lead | Visual Analog Scale (VAS) for Back Pain at SCS Trial | 30.5 units on a scale | Standard Deviation 25.4 |
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)
Time frame: 12 months after activation of permanent SCS implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | EQ-5D at 12 Month | 0.69 score on a scale | Standard Deviation 0.22 |
| Paresthesia Mapping Lead | EQ-5D at 12 Month | 0.67 score on a scale | Standard Deviation 0.21 |
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)
Time frame: 3 months after activation of permanent SCS implant
Population: Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | EQ-5D at 3 Month | 0.73 score on a scale | Standard Deviation 0.2 |
| Paresthesia Mapping Lead | EQ-5D at 3 Month | 0.63 score on a scale | Standard Deviation 0.22 |
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)
Time frame: 6 months after activation of permanent SCS implant
Population: One patient had missing data in the anatomically positioned lead group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | EQ-5D at 6 Month | 0.62 score on a scale | Standard Deviation 0.27 |
| Paresthesia Mapping Lead | EQ-5D at 6 Month | 0.64 score on a scale | Standard Deviation 0.22 |
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)
Time frame: after 2 weeks of SCS trial
Population: Data missing for one patient in the anatomically positioned lead group and one patient for the paresthesia mapping lead group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | EQ-5D at SCS Trial | 0.68 score on a scale | Standard Deviation 0.17 |
| Paresthesia Mapping Lead | EQ-5D at SCS Trial | 0.65 score on a scale | Standard Deviation 0.16 |
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)
Time frame: 12 months after activation of permanent SCS implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | ODI at 12 Months | 33.9 score on a scale | Standard Deviation 21.5 |
| Paresthesia Mapping Lead | ODI at 12 Months | 39.4 score on a scale | Standard Deviation 20.8 |
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)
Time frame: 3 months after activation of permanent SCS implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | ODI at 3 Months | 33.8 score on a scale | Standard Deviation 22.6 |
| Paresthesia Mapping Lead | ODI at 3 Months | 37.3 score on a scale | Standard Deviation 20.5 |
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)
Time frame: 6 months after activation of permanent SCS implant
Population: One patient had missing data in the anatomically positioned lead group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | ODI at 6 Months | 41.5 score on a scale | Standard Deviation 23.5 |
| Paresthesia Mapping Lead | ODI at 6 Months | 36.9 score on a scale | Standard Deviation 20.2 |
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)
Time frame: first SCS trial assessment (up to two weeks after electrodes implantation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | ODI at SCS Trial | 40.2 score on a scale | Standard Deviation 17.1 |
| Paresthesia Mapping Lead | ODI at SCS Trial | 41.8 score on a scale | Standard Deviation 16.5 |
Secondary
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Time frame: 12 month follow up
Population: One patient had missing data in the anatomically positioned lead group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anatomically Positioned Lead | Satisfaction Questionnaire | very dissatisfied | 0 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | neither satisfied nor dissatisfied | 0 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | very satisfied | 8 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | satisfied | 9 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | dissatisfied | 1 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | very satisfied | 13 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | very dissatisfied | 0 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | dissatisfied | 1 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | neither satisfied nor dissatisfied | 2 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | satisfied | 4 Participants |
Secondary
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Time frame: 3 month follow up
Population: One patient had missing data in the paresthesia mapping lead group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anatomically Positioned Lead | Satisfaction Questionnaire | dissatisfied | 0 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | satisfied | 8 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | neither satisfied or dissatisfied | 4 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | very satisfied | 9 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | very dissatisfied | 0 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | very satisfied | 12 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | very dissatisfied | 0 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | dissatisfied | 0 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | neither satisfied or dissatisfied | 1 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | satisfied | 7 Participants |
Secondary
Satisfaction Questionnaire
questionnaire regarding patient satisfaction with the therapy
Time frame: 6 month follow up
Population: four patients had missing data in the anatomically positioned lead group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anatomically Positioned Lead | Satisfaction Questionnaire | very dissatisfied | 1 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | satisfied | 4 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | neither satisfied nor dissatisfied | 4 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | very satisfied | 7 Participants |
| Anatomically Positioned Lead | Satisfaction Questionnaire | dissatisfied | 1 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | very satisfied | 11 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | very dissatisfied | 0 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | neither satisfied nor dissatisfied | 3 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | satisfied | 5 Participants |
| Paresthesia Mapping Lead | Satisfaction Questionnaire | dissatisfied | 2 Participants |
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)
Time frame: 12 months after activation of permanent SCS implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | Visual Analog Scale (VAS) for Back Pain at 12 Months | 24 units on a scale | Standard Deviation 24.5 |
| Paresthesia Mapping Lead | Visual Analog Scale (VAS) for Back Pain at 12 Months | 31.8 units on a scale | Standard Deviation 26.4 |
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)
Time frame: 3 months after activation of permanent SCS implant
Population: one in the paresthesia mapping lead group had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | Visual Analog Scale (VAS) for Back Pain at 3 Months | 28.5 units on a scale | Standard Deviation 28.1 |
| Paresthesia Mapping Lead | Visual Analog Scale (VAS) for Back Pain at 3 Months | 24.6 units on a scale | Standard Deviation 19 |
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)
Time frame: 6 months after activation of permanent SCS implant
Population: Two subjects had missing data in the paresthesia mapping lead group, one patient had missing data in the anatomically positioned lead group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomically Positioned Lead | Visual Analog Scale (VAS) for Back Pain at 6 Months | 24 units on a scale | Standard Deviation 24.5 |
| Paresthesia Mapping Lead | Visual Analog Scale (VAS) for Back Pain at 6 Months | 35.2 units on a scale | Standard Deviation 23.7 |