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).

Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)

Back Pain

Low Back Pain

SPRINT Peripheral Nerve Stimulation (PNS) System

A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

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.

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.

All subjects were asked to complete daily diaries to record their worst pain intensity on
each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain
Inventory-Short Form Question 3 (BPI-3). The BPI-3 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. The mean score across all subjects for each time point is
reported.

The Oswestry Disability Index (ODI) is a widely used assessment designed to measure the
degree of disability in people with low back pain. This validated questionnaire includes
topics concerning the intensity of pain, the subject's ability to perform normal daily
activities such as personal care, walking, sitting, or standing, and how pain affects the
subject's sex life, social life, and travel. The scale ranges from 0-100 and higher
scores indicate greater disability due to low back pain. The mean score across all
subjects at baseline and end of treatment (EOT) is reported here.

The RAND 36-Item Short Form Health Survey is a widely accepted form used to quantify
quality of life. The survey consists of 8 categories with a total of 36 questions
regarding the subject's general health and activities. The survey assesses physical and
emotional problems associated with pain during the past 4 weeks. Each category is scored
on a 0-100 scale, where a higher score indicates a more favorable health state. The score
for each category was calculated at baseline and End of Treatment (EOT) for each subject.
The change in each category score from Baseline to EOT was then calculated for each
subject (with a positive change indicating an increase in health-related quality of
life). The mean and standard deviation of the subjects' changes in each category are
presented below.

The Beck Depression Inventory (BDI-II) is a validated, 21-question survey used to measure
depression severity. Questions are rated on a scale from 0 to 3, and the scores from each
question are totaled to provide an overall score ranging between 0 to 63. Scores from
0-13 indicate minimal depression, 14-19 mild depression, 20-28 moderate depression, and
29-63 indicates severe depression. The average total scores across subjects were
calculated at baseline and end of treatment (EOT).

The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement
with treatment on a 7-point scale where 1 represents "very much worse" and 7 represents
"very much improved" as compared to before stimulation treatment. The subjects combine
all the components of their experience into one overall score. The number of participants
with each rating after 8 weeks of treatment is reported here.

Question 9 of the Brief Pain Inventory-Short Form (BPI-9) is a 7-part question that
assesses the level of interference that subjects experience in their daily lives due to
pain. The 7 categories are general activity, mood, walking ability, normal work,
relations with other people, sleep, and enjoyment of life. Subjects were asked to rate
how much their low back pain interferes with each aspect on an 11-point numerical scale
where 0 represents "Does Not Interfere" and 10 represents "Completely Interferes." The
average of these 7 scores was calculated for each subject. The mean was taken across
subjects for each time point.

All study subjects will have up to 4 Leads placed in their low back, will use the SPRINT
Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?

Locations

Location

Status