Chronic Pain
Conditions
Keywords
neurostimulation, spinal cord stimulation, peripheral nerve stimulation
Brief summary
The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.
Interventions
DEVICENeurostimulation device implantation
Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial. Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 * Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall * Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent * Subject is willing and able to comply with all protocol-required follow-up evaluations * 18 years of age or older when written informed consent is obtained * Subject signs informed consent
Exclusion criteria
* Unable to operate the Precision Spectra™ System either by self or with a caregiver * Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine * Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall * Is a high surgical risk * Currently on any anticoagulant medications that cannot be discontinued during perioperative period * Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG * Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study * Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator * Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial. * Failed to achieve satisfactory relief during the stimulation trial phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation | 90-days post permanent implantation | Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire. |
| Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation | 365 days post permanent implantation | Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire. |
Countries
Australia, Belgium, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neurostimulation for Chronic Pain Neurostimulation (spinal cord stimulation with or without peripheral nerve stimulation of the trunk) for chronic intractable pain of the trunk and/or limbs.
Neurostimulation device implantation: Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.
Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Neurostimulation for Chronic Pain |
|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 4 / 40 |
| serious Total, serious adverse events | 11 / 40 |
Outcome results
Primary
Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation
Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time frame: 90-days post permanent implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neurostimulation for Chronic Pain | Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation | 32 Participants |
Primary
Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation
Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.
Time frame: 365 days post permanent implantation
Population: A sub-group of subjects utilizing more than 2 IPG ports at 365 Days post-IPG implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neurostimulation for Chronic Pain | Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation | 21 Participants |