Chronic Pain
Conditions
Brief summary
To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.
Detailed description
This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.
Interventions
DEVICELow Rate Stimulation
Stimulation was given at a rate of 2 Hz.
DEVICEHigh Rate Stimulation
Stimulation was given at a rate of 1200 Hz.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic intractable pain of the trunk and/or limbs * Documented history of trunk and/or limb pain of at least 180 days * Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit * Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit * If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation * Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations * Subject is able to independently read and complete all questionnaires and/or assessments provided in English * 18 years of age or older when written informed consent is obtained * Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English
Exclusion criteria
* Unable to operate the Precision Plus system * Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine * Is a high surgical risk * Is diabetic * Is immunocompromised * Currently on any anticoagulant medications that cannot be discontinued during perioperative period * Untreated major depression or untreated generalized anxiety disorder * Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder * Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8 * Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care * Current abuse of alcohol or illicit drugs * Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s). * Subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study * Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator * Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Back Pain Intensity | For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject). | Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation. |
Countries
United States
Participant flow
Pre-assignment details
Although 20 subjects enrolled (11 to receive low rate stimulation first, 9 to receive high rate stimulation first), 2 subjects randomized to first receive low rate stimulation were withdrawn prior to stimulation due to difficulties implanting the device. Thus, 18 out of 20 enrolled subjects (9 from each group) started their first intervention.
Participants by arm
| Arm | Count |
|---|---|
| Low Rate Followed By High Rate Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days. | 11 |
| High Rate Followed By Low Rate Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days. | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Low Rate Followed By High Rate | High Rate Followed By Low Rate | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.57 | 49.4 years STANDARD_DEVIATION 9.49 | 56.5 years STANDARD_DEVIATION 11.81 |
| Race/Ethnicity, Customized Caucasian | 9 participants | 8 participants | 17 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 participants | 1 participants | 3 participants |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 1 / 18 | 5 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Change in Back Pain Intensity
Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
Time frame: For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Rate Subperception Precision SCS Trial Therapy | Change in Back Pain Intensity | 20.9 Percent Change From Baseline | Standard Deviation 31.6 |
| High Rate Subperception Precision SCS Trial Therapy | Change in Back Pain Intensity | 25.6 Percent Change From Baseline | Standard Deviation 38.1 |
p-value: 0.74ANOVA