Chronic Neuropathic Pain in the Low Back and Legs
Conditions
Keywords
chronic neuropathic pain in the low back and legs, subperception spinal cord stimulation
Brief summary
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
Interventions
DEVICEBoston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
Spinal cord stimulation for the management of chronic neuropathic pain
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale) * Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents * Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion) Key
Exclusion criteria
* Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings * Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preferred Field Shape | 42 days post randomization | Number of participants preferring bipolar field shape and alternative field shape |
Countries
United Kingdom
Participant flow
Pre-assignment details
16 subjects were enrolled in the study. 10 were withdrawn prior to randomization. 6 were randomized. Statistically relevant conclusions cannot be made from this small sample size.
Participants by arm
| Arm | Count |
|---|---|
| Bipolar Then Alternative Field Shape Stimulation Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with bipolar stimulation for 21 days, then alternative field shape stimulation for 21 days | 2 |
| Alternative Then Bipolar Field Shape Stimulation Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System: Spinal cord stimulation for the management of chronic neuropathic pain programmed with alternative field shape stimulation for 21 days, then bipolar stimulation for 21 days | 4 |
| Total | 6 |
Baseline characteristics
| Characteristic | Alternative Then Bipolar Field Shape Stimulation | Total | Bipolar Then Alternative Field Shape Stimulation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 4 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Patient Preferred Field Shape
Number of participants preferring bipolar field shape and alternative field shape
Time frame: 42 days post randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bipolar Then Alternative Field Shape Stimulation | Patient Preferred Field Shape | Preferred Bipolar Field Shape | 2 Participants |
| Bipolar Then Alternative Field Shape Stimulation | Patient Preferred Field Shape | Preferred Alternative Field Shape | 0 Participants |
| Alternative Then Bipolar Field Shape Stimulation | Patient Preferred Field Shape | Preferred Bipolar Field Shape | 2 Participants |
| Alternative Then Bipolar Field Shape Stimulation | Patient Preferred Field Shape | Preferred Alternative Field Shape | 2 Participants |