An interventional study of lead placement followed by BurstDR stimulation in Chronic, Intractable Pain of the Trunk and/or Lower Limbs, sponsored by Abbott Medical Devices. Completed at 25 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
Prospective, multi-center, randomized, single blind study
This clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for BurstDR™ during the trial evaluation period with the St Jude Medical™ Invisible Trial System. Subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows:
Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
If the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. Subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. Subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. At the end of the extended trial evaluation period, subjects will exit the clinical investigation.
Exclusion Criteria:
Group 1 (AB): anatomic lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Device: lead placement followed by BurstDR stimulation
Group 2 (TB): targeted lead placement followed by BurstDR™ stimulation during an initial trial evaluation period
Device: lead placement followed by BurstDR stimulation
lead placement followed by BurstDR stimulation
Also known as: Spinal Cord Stimulation non-surgical Leads, Spinal Cord Stimulation Clinician Programmer, Spinal Cord Stimulation Patient Controller
Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period
The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period. Qualification for permanent system implant was defined by a composite where all the following conditions were met: * ≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 3 days * Physician recommends subject for permanent system implant * Subject reports a willingness to pursue a permanent system implant Subjects did not qualify for permanent system implant if they met both of the following: * \< 50% PRP (patient reported pain relief) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 5 days
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study
The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Procedural Characteristics of Subjects With One Trial Lead Implanted (US)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With One Trial Lead Implanted (OUS)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With One Trial Lead Implanted (Worldwide)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With Two Trial Leads Implanted (US)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With Two Trial Leads Implanted (OUS)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With Two Trial Leads Implanted (Worldwide)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With One Permanent Lead Implanted (OUS)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Procedural Characteristics of Subjects With Two Permanent Leads Implanted (OUS)
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
Time frame: Trial system implant
Programming Time Needed for Each Randomized Group
The programming time observed for both randomized groups
Time frame: Trial system implant
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
Time frame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
Number of Subjects Who Have Affirmative Assessment for Each of the Independent Criteria Required for Qualification for Permanent Implant
Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion.
Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP)
Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Rate of Serious Adverse Device Effects (SADE) Based on Randomization
Rate of serious adverse device effects based on each randomized group.
Time frame: From pre-implant to exit of the study, approximately 3 to 14 days
Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group
A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type
The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
Time frame: From pre-implant to end of initial trial evaluation period, 3 to 5 days of BurstDR stimulation
Clinician Assessment of Anesthesia Related Difficulty and Lead Placement Difficulty
Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.
Time frame: Trial system implant
Clinician Affinity for Lead Placement Technique at the End of Trial Procedure
Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.
Time frame: Trial system implant
Permanent System Qualification Rate at the End of Extended Trial Period
The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.
Time frame: From pre-implant to end of extended trial period, a minimum of 5 days BurstDR stimulation plus an additional minimum of 3 days tonic stimulation
The subject enrollment for the DELIVERY study began on 22 September 2017, at 23 clinical sites in the United States, Europe, and Australia. A total of 270 subjects were randomized into the two treatment groups (Anatomic Lead Placement and Targeted lead placement).
| Milestone | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Started | 135 | 135 |
| Received lead implant | 129 | 123 |
| Completed initial trial | 126 | 122 |
| Qualified for permanent implant | 103 | 93 |
| Not qualified for permanent implant | 19 | 20 |
| Completed extended trial with tonic stim | 8 | 12 |
| Exit study | 11 | 8 |
| Completed | 111 | 101 |
| Not completed | 24 | 34 |
The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period. Qualification for permanent system implant was defined by a composite where all the following conditions were met: * ≥ 50% patient reported pain relief (PRP) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 3 days * Physician recommends subject for permanent system implant * Subject reports a willingness to pursue a permanent system implant Subjects did not qualify for permanent system implant if they met both of the following: * \< 50% PRP (patient reported pain relief) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 5 days
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Qualification Rate for Permanent System Implant at the End of the Initial Trial Evaluation Period | 103 | 93 |
The physician preference for placement of leads was noted by giving them the option of choosing which lead placement technique they preferred - anatomic or targeted lead placement technique.
| Participants | Physicians Who Prefer Anatomic Lead Placement | Physicians Who Prefer Targeted Placement of Leads |
|---|---|---|
| Rate of Physician Preference for Anatomic Placement Versus Targeted Placement at the End of the Study | 14 | 6 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 57.3 ± 4.7 | 52.9 ± 16.9 |
| Implant procedure time | 38 ± 9.4 | 30.3 ± 14.2 |
| Intraoperative fluoroscopy time | 2.48 ± 1.95 | 2.65 ± 2.05 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 38 ± 11.8 | 46.2 ± 19.2 |
| Implant procedure time | 11.6 ± 6.8 | 21.5 ± 15.5 |
| Intraoperative fluoroscopy time | 4.22 ± 2.56 | 4.28 ± 2.68 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 45.0 ± 13.6 | 49.8 ± 17.6 |
| Implant procedure time | 21.2 ± 15.2 | 26.2 ± 14.9 |
| Intraoperative fluoroscopy time | 3.59 ± 2.42 | 3.40 ± 2.41 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 40 ± 12.4 | 45 ± 13.7 |
| Implant procedure time | 14 ± 8.2 | 19.9 ± 10 |
| Intraoperative fluoroscopy time | 1.52 ± 0.98 | 1.68 ± 1.24 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 45.9 ± 10.4 | 57.3 ± 15.8 |
| Implant procedure time | 19.1 ± 11.7 | 30 ± 14.2 |
| Intraoperative fluoroscopy time | 3.5 ± 1.56 | 3.24 ± 1.24 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 40.4 ± 12.3 | 45.9 ± 14.1 |
| Implant procedure time | 14.3 ± 8.5 | 20.6 ± 10.6 |
| Intraoperative fluoroscopy time | 1.65 ± 1.13 | 1.79 ± 1.30 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 59.6 ± 16.2 | 68.6 ± 19.7 |
| Implant procedure time | 11.6 ± 9.4 | 22.6 ± 12.2 |
| Intraoperative fluoroscopy time | 2.12 ± 0.88 | 2.83 ± 1.64 |
Procedural characteristics including overall procedure time (room-in to room-out, implant procedure time (needle-in to needle-out, and the intraoperative time for the fluoroscopy procedure were measured.
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Overall procedure time | 56 ± 4.6 | 92.3 ± 23.7 |
| Implant procedure time | 19.3 ± 5.1 | 27.3 ± 6.5 |
| Intraoperative fluoroscopy time | 5.96 ± 3.09 | 4.93 ± 4.45 |
The programming time observed for both randomized groups
| Minutes | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Programming Time Needed for Each Randomized Group | 5 ± 6.4 | 6 ± 6 |
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
| Score on a scale | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to End of Initial Trial Evaluation Period | 4.2 ± 2.8 | 4.3 ± 2.7 |
Subjects were interviewed using the pain NRS scale consisting of 1 question and were asked to rate their average pain specific to the area(s) of chronic pain being treated over the past 24 hours on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
| Score on a scale | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Change From Pre-implant Numerical Rating Scale (NRS) in Each Randomized Group to the End of the Extended Trial Evaluation Period | 2.4 ± 2.6 | 2.6 ± 2.2 |
Number of subjects in each randomized group who have affirmative assessment for each of the independent criteria required for qualification for permanent implant
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| ≥ 50% patient reported pain relief (PRP) | 107 | 99 |
| Trial period lasted for a minimum of 3 days | 126 | 122 |
| Physician recommendation for permanent implant | 109 | 104 |
| Subject's willingness for a permanent implant | 106 | 100 |
Number of subjects in each randomized group who do not qualify for permanent implant but proceeded with permanent implant per physician discretion.
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Proportion of Subjects Who do Not Qualify for Permanent Implant But Proceeded With Permanent Implant Per Physician Discretion. | 1 | 2 |
Time from trial system to ≥ 50% patient reported pain relief measured by the number of days (also known as " wash-in period")
| Days | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Time From Trial System to ≥ 50% Patient Reported Pain Relief (PRP) | 3.0 ± 2.0 | 3.3 ± 2.8 |
Rate of serious adverse device effects based on each randomized group.
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Rate of Serious Adverse Device Effects (SADE) Based on Randomization | 1 | 1 |
A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Number and Proportion of Meaningful Lead Migrations During the Initial Trial Evaluation Periods by Treatment Group | 1 | 1 |
The number and proportion of meaningful lead migrations during initial trial evaluation period was assessed based on lead type (either Temporary Lead Implant or Permanent Lead Implant). A meaningful lead migration is defined as a lead migration resulting in the inability to program for therapeutic response
| Participants | Subjects With Temporary Lead Implant | Subjects With Permanent Lead Implant |
|---|---|---|
| Number and Proportion of Meaningful Lead Migrations During Initial Trial Evaluation Period by Lead Type | 2 | 0 |
Clinician assessment of anesthesia related difficulty and lead placement difficulty using a Likert scale ranging from ' No difficulty' to extreme difficulty and clinician affinity for lead placement technique at the end of the trial implant procedure.
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Anesthesia related difficulty — No difficulty | 113 | 99 |
| Anesthesia related difficulty — Little difficulty | 12 | 17 |
| Anesthesia related difficulty — Moderate difficulty | 4 | 7 |
| Anesthesia related difficulty — Severe difficulty | 0 | 0 |
| Anesthesia related difficulty — Extreme difficulty | 0 | 0 |
| Anesthesia related difficulty — Could not place leads | 0 | 0 |
| Lead placement difficulty — No difficulty | 82 | 77 |
| Lead placement difficulty — Little difficulty | 28 | 28 |
| Lead placement difficulty — Moderate difficulty | 14 | 16 |
| Lead placement difficulty — Severe difficulty | 1 | 1 |
| Lead placement difficulty — Extreme difficulty | 2 | 0 |
| Lead placement difficulty — Could not place leads | 2 | 1 |
Clinician affinity for lead placement technique at the end of the trial implant procedure using a Likert scale ranging from 0 being 'Not all' to 4 being ' very much'.
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| 0 | 4 | 1 |
| 1 | 3 | 3 |
| 2 | 4 | 3 |
| 3 | 13 | 4 |
| 4 | 46 | 11 |
| This was my usual practice | 59 | 101 |
The qualification rate for permanent implant was calculated for the subjects who completed the extended trial period.
| Participants | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Permanent System Qualification Rate at the End of Extended Trial Period | 5 | 11 |
Collected over Approximately 3 to 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 (AB) | 0/135 (0%) | 2/135 (1.5%) | 4/135 (3%) |
| Group 2 (TB) | 0/135 (0%) | 1/135 (0.7%) | 6/135 (4.4%) |
| Event | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| StrokeNervous system disorders | 1/135 | 0/135 |
| Spinal Cord CompressionInjury, poisoning and procedural complications | 1/135 | 0/135 |
| Stimulation in unwanted placesInjury, poisoning and procedural complications | 0/135 | 1/135 |
| Event | Group 1 (AB) | Group 2 (TB) |
|---|---|---|
| Lead MigrationProduct Issues | 2/135 | 2/135 |
| HematomaInjury, poisoning and procedural complications | 1/135 | 0/135 |
| Unpleasant sensations or Motor disturbances Including Involuntary Movement caused by high outputInjury, poisoning and procedural complications | 0/135 | 1/135 |
| Persistant pain lead siteInjury, poisoning and procedural complications | 1/135 | 1/135 |
| Cerebrospinal fluid leakageInjury, poisoning and procedural complications | 0/135 | 1/135 |
| New leg pain on walking instead of original dysaesthetic sensationInjury, poisoning and procedural complications | 0/135 | 1/135 |
The baseline characteristics for all subjects randomized to anatomic or targeted lead placement were measured.
| Age, Continuous(Years) | Group 1 (AB) | Group 2 (TB) | Total |
|---|---|---|---|
| Mean | 61.8 ± 13.2 | 63.9 ± 13.8 | 62.8 ± 13.5 |
| Sex: Female, Male(Participants) | Group 1 (AB) | Group 2 (TB) | Total |
|---|---|---|---|
| Female | 78 | 87 | 165 |
| Male | 57 | 48 | 105 |
| Race (NIH/OMB)(Participants) | Group 1 (AB) | Group 2 (TB) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 5 | 3 | 8 |
| White | 103 | 98 | 201 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 14 | 21 |
| Region of Enrollment(participants) | Group 1 (AB) | Group 2 (TB) | Total |
|---|---|---|---|
| Austria | 2 | 3 | 5 |
| Netherlands | 1 | 1 | 2 |
| Italy | 4 | 4 | 8 |
| Australia | 7 | 7 | 14 |
| Germany | 12 | 11 | 23 |
| United States | 109 | 109 | 218 |
| Years of having chronic pain(years) | Group 1 (AB) | Group 2 (TB) | Total |
|---|---|---|---|
| Mean | 12.23 ± 11.83 | 10.69 ± 11.11 | 11.46 ± 11.48 |
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