Chronic Pain
Conditions
Brief summary
The purpose of this study is to evaluate patient preference of the Boston Scientific Corporation (BSC) commercially approved spinal cord stimulation (SCS) systems with the Observational Mechanical Gateway (OMG) in patients who failed non-BSC SCS trial therapy.
Detailed description
Spinal cord stimulation (SCS) is an established therapy for the treatment of chronic pain of the trunk and/or limbs. Standard practice includes a screening trial, typically lasting from 3 days to 7 days or more, for both the physician and the patient to evaluate whether SCS therapy is appropriate for permanent implantation. Screening trial success (hereafter referred to as a trial) is often considered predictive of long-term success of the therapy, although that has never been definitively demonstrated. Boston Scientific Corporation (BSC) developed the Observational Mechanical Gateway (OMG) connectors to allow patients who previously underwent an SCS trial using Medtronic or St Jude Medical leads, operating room cables (OR-cables), and external trial stimulators (ETSs), to be able to connect to BSC commercially approved Spinal Cord Stimulation (SCS) trial systems to evaluate the BSC SCS therapy in the physician office setting prior to removal of the non-BSC leads.
Interventions
DEVICENon Boston Scientific SCS Trial Therapy
No procedures will be attempted as part of this study. This intervention refers to connection and activation of a previously implanted and programmed FDA-approved non Boston Scientific SCS trial system for 30 minutes of SCS therapy for pain
DEVICEBSC approved SCS Trial Therapy w/ OMG
No procedures will be attempted as part of this study. This intervention refers to connection and activation of all Boston Scientific commercially approved SCS trial systems for 30 minutes of SCS therapy for pain
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
Key Inclusion Criteria: * Chronic intractable pain of the trunk and/or lower extremities * History of trunk and/or lower extremity pain lasting at least 6 months * Study candidate completed a spinal cord stimulation (SCS) trial of a FDA-approved non-Boston Scientific Corporation (non-BSC) system, exclusively for the treatment of chronic intractable pain of the trunk and/or lower extremities, that will not proceed to permanent implantation due to unsatisfactory treatment or in the physician's opinion received sub-optimal results * Currently implanted with FDA-approved non-BSC SCS lead(s) exclusively in the thoracolumbar epidural space that are temporarily anchored for non-surgical removal at the termination of the screening trial period and which are approved for use with either the Observational Mechanical Gateway (OMG) A or OMG-M, per the OMG directions for use Key
Exclusion criteria
* Primary source of pain is cancer-related, pelvic, visceral or angina * Investigator-suspected gross lead migration during the non-BSC trial period which may preclude the study candidate from receiving adequate SCS therapy * Study candidate reports \<10% paresthesia coverage of overall pain while running the preferred stimulation settings on the non-BSC SCS system at the end of the non-BSC SCS screening trial period * Study candidate unwilling to tolerate implantation with an SCS system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Treatment Preference | 30 minutes after activation of stimulation | Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment to Control Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy) | 13 |
| Control to Treatment Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy) | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Treatment to Control | Control to Treatment | Total |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 11.71 | 56 years STANDARD_DEVIATION 12.02 | 56.9 years STANDARD_DEVIATION 11.68 |
| Region of Enrollment: United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Subject's Treatment Preference
Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline
Time frame: 30 minutes after activation of stimulation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment to Control | Subject's Treatment Preference | Period 1 No, Period 2 Yes | 1 participants |
| Treatment to Control | Subject's Treatment Preference | Period 1 Yes, Period 2 Yes | 6 participants |
| Treatment to Control | Subject's Treatment Preference | Period 1 No, Period 2 No | 4 participants |
| Treatment to Control | Subject's Treatment Preference | Period 1 Yes, Period 2 No | 1 participants |
| Control to Treatment | Subject's Treatment Preference | Period 1 No, Period 2 No | 4 participants |
| Control to Treatment | Subject's Treatment Preference | Period 1 Yes, Period 2 Yes | 3 participants |
| Control to Treatment | Subject's Treatment Preference | Period 1 No, Period 2 Yes | 4 participants |
| Control to Treatment | Subject's Treatment Preference | Period 1 Yes, Period 2 No | 2 participants |