A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Back Pain
- Sponsor
- SPR Therapeutics, Inc.
- Enrollment
- 166
- Locations
- 8
- Primary Endpoint
- Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators).
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 21 years of age
- •Chronic low back pain
Exclusion Criteria
- •Infection on or around the low back
- •Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)
- •Implanted electronic device
- •Body Mass Index (BMI) \> 40
Outcomes
Primary Outcomes
Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
Time Frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
All subjects were asked to complete daily diaries to record their average pain intensity on each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain Inventory-Short Form Question 5 (BPI-5). The BPI-5 uses an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for the baseline and end of treatment (EOT) diary periods were calculated and percent reduction was determined. Subjects that achieved ≥30% reduction in pain, were considered successful.
Number of Subjects That Experienced at Least One Study-Related Adverse Event
Time Frame: Up to 15 months for each subject from baseline to the last study visit
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Secondary Outcomes
- Patient Global Impression of Change (PGIC) Survey(8-weeks post-Start of Treatment (SOT))
- Mean Change in Health-Related Quality of Life(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Worst Pain Intensity(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Oswestry Disability Index (ODI)(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Pain Interference(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Beck Depression Inventory (BDI-II)(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))