Chronic Pain
Conditions
Keywords
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Brief summary
The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
Detailed description
The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.
Interventions
DEVICEConventional single source programming
Precision Spectra SCS System using conventional single source programming.
DEVICEPrecision Spectra SCS System advanced programming
Precision Spectra SCS System using advanced programming
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets RELIEF Registry criteria for inclusion * Primary complaint of persistent or recurrent low back pain, with or without leg pain * Signed a valid, IRB/EC-approved informed consent form
Exclusion criteria
* Meets any RELIEF Registry criteria for exclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Paresthesia Coverage ≥50% | 7, 14 days post activation | Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported. |
Countries
United States
Participant flow
Pre-assignment details
17 subjects were enrolled in the study. 5 were withdrawn prior to randomization: 4 were withdrawn as failing to meet inclusion criteria and 1 at the subject's request prior to randomization. 12 were randomized, but 1 was randomized in error and was withdrawn same day. Statistically relevant conclusions cannot be made from this small sample size.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Programming, Then Advanced Programming Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming.
Conventional single source programming: Precision Spectra SCS System using conventional single source programming.
Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming. | 5 |
| Advanced Programming, Then Conventional Programming Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming.
Conventional single source programming: Precision Spectra SCS System using conventional single source programming.
Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming. | 7 |
| Total | 12 |
Baseline characteristics
| Characteristic | Conventional Programming, Then Advanced Programming | Advanced Programming, Then Conventional Programming | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 6 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 7 participants | 12 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Number of Participants With Paresthesia Coverage ≥50%
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.
Time frame: 7, 14 days post activation
Population: All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conventional Programming, Then Advanced Programming | Number of Participants With Paresthesia Coverage ≥50% | Advanced Programming | 3 Participants |
| Conventional Programming, Then Advanced Programming | Number of Participants With Paresthesia Coverage ≥50% | Conventional Programming | 3 Participants |
| Advanced Programming, Then Conventional Programming | Number of Participants With Paresthesia Coverage ≥50% | Advanced Programming | 5 Participants |
| Advanced Programming, Then Conventional Programming | Number of Participants With Paresthesia Coverage ≥50% | Conventional Programming | 5 Participants |