Back Pain
Conditions
Brief summary
This study evaluates use of DISCSS vis SCS. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three-four days.
Detailed description
This investigation will be performed as a prospective, multicenter, open-label feasibility study. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three to four days. The investigational product for this feasibility trial will be the DISCSS™ system, not the commercially available trial SCS system. Exposure to the commercially available trial SCS system will be considered background therapy. The purpose of the background therapy phase is to establish baseline pain levels and determine patients' eligibility to continue to the investigational phase of the trial using the DISCSS™ SCS phase of the trial. Pain assessment and complications data from the commercial spinal stimulation system will be collected during the background therapy phase. The pain and complications data from the background therapy phase will not be analyzed in terms of the study endpoints.
Interventions
DEVICEDISCSS Device
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of the current study.
Sponsors
Meagan Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
prospective, multi-center, open-label, feasibility study
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age greater than 21 years and less than 80 years 2. Has a diagnosis of chronic neuropathic pain of trunk and limbs 3. Is eligible for and participating in a spinal cord stimulation trial of a commercially available SCS trial system. Subjects will be evaluated at the end of the background Commercial SCS Device phase for complications and appropriateness to continue to the investigational phase with the DISCSS™ system. Complications from the background phase with the commercial SCS device may include, but are not limited to unusual pain or discomfort during the trial stimulation, local skin reactions or infection at the implant site. 4. Has a Back Pain Score of minimum intensity 5.0 on a Numeric Rating Scale (NRS) 5. Has an NRS Back Pain Score that is greater than both Leg Pain Scores 6. Is not a candidate for revision surgery 7. Has completed a minimum of 6 weeks of conservative therapy (physical therapy, anti-inflammatory medications, or similar therapies) with limited or no reduction in back pain 8. Is willing to adhere to the warnings associated with the DISCSS™ system 9. Is willing to halt and/or modify the use of all prescription and over-the-counter analgesics per the Investigator's direction during study participation 10. Is capable of providing written informed consent 11. Is able to comply with the requirements of study visits, follow-up phone visits and self-assessment questionnaires
Exclusion criteria
1. Is a poor surgical candidate by determination of the Investigator 2. Is unable to operate or understand the use of the commercial or investigational Spinal Cord Stimulator systems 3. Has an active systemic infection 4. Has exposure to shortwave, microwave or ultrasound diathermy at home or at work 5. Has occupational exposure to high levels of non-ionizing radiation such as radio or cell phone transmission stations, facilities using radiofrequency heat sealers or induction heaters, or electric power infrastructure controlled environments 6. Has an implanted cardiac system (e.g. pacemakers) 7. Is currently participating in another clinical study 8. Is currently pregnant or lactating, or not using adequate birth control 9. Has any untreated major psychiatric comorbidity 10. Has serious drug-related behavioral issues per Investigator's assessment 11. Has a bleeding complication or coagulopathy 12. Requires concurrent use of anticoagulant therapy such as heparin, warfarin, rivaroxaban, dabigatran, apixaban, edoxaban, enoxaparin, fondaparinux 13. Is immunocompromised and at risk for infection 14. Has insulin-dependent diabetes not controlled through diet and/or medication 15. Has chronic pain related to malignancy 16. Is otherwise determined, based on the opinion of the Investigator to be an unsuitable candidate for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Day 1) to Visit 5 in Back Pain. | Baseline to visit 5 | Change from baseline (day 1) to visit 5 (day 10-11) in patient-reported pain intensity, measured on a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Visit 4 (Day 6-7), and Visit 5 (Day 10-11) | Incidence of adverse events arising from the DISCSS treatment phase |
| Patient Satisfaction | Visit 5 (Day 10-11) | Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DISCSS Device This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | DISCSS Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 56.9 years STANDARD_DEVIATION 11.6 |
| Height | 67.6 Inches STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 17 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 5 / 18 | 0 / 18 |
| serious Total, serious adverse events | 1 / 18 | 0 / 18 |
Outcome results
Primary
Change From Baseline (Day 1) to Visit 5 in Back Pain.
Change from baseline (day 1) to visit 5 (day 10-11) in patient-reported pain intensity, measured on a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain).
Time frame: Baseline to visit 5
Population: Intent to treat.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DISCSS Device | Change From Baseline (Day 1) to Visit 5 in Back Pain. | Overall | -4.2 score on a scale | Standard Deviation 2.3 |
| DISCSS Device | Change From Baseline (Day 1) to Visit 5 in Back Pain. | Lower Extremity | -3.9 score on a scale | Standard Deviation 2.5 |
| DISCSS Device | Change From Baseline (Day 1) to Visit 5 in Back Pain. | Back | -4.4 score on a scale | Standard Deviation 2.3 |
Secondary
Incidence of Adverse Events
Incidence of adverse events arising from the DISCSS treatment phase
Time frame: Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
Population: All enrolled subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DISCSS Device | Incidence of Adverse Events | Serious Adverse Event | 1 Adverse Events |
| DISCSS Device | Incidence of Adverse Events | Adverse Event | 6 Adverse Events |
Secondary
Patient Satisfaction
Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.
Time frame: Visit 5 (Day 10-11)
Population: Intent to treat.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DISCSS Device | Patient Satisfaction | Very Satisfied | 9 Participants |
| DISCSS Device | Patient Satisfaction | Satisfied | 4 Participants |
| DISCSS Device | Patient Satisfaction | Somewhat Satisfied | 3 Participants |
| DISCSS Device | Patient Satisfaction | Dissatisfied | 1 Participants |