Clinical trial NCT03179202: Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
Official title: A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Low Back Pain
Keywords: Electrical Stimulation
Neurostimulation
Neuromodulation
Back Pain
Low Back Pain
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 166
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Key Inclusion Criteria:

* At least 21 years of age
* Chronic low back pain

Key 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
* Pregnant

Primary outcomes:
measure: Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
timeFrame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
measure: Number of Subjects That Experienced at Least One Study-Related Adverse Event
timeFrame: Up to 15 months for each subject from baseline to the last study visit
Secondary outcomes:
measure: Worst Pain Intensity
timeFrame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
measure: Mean Change in Health-Related Quality of Life
timeFrame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
measure: Patient Global Impression of Change (PGIC) Survey
timeFrame: 8-weeks post-Start of Treatment (SOT)
measure: Pain Interference
timeFrame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Hope Research Institute
state: Arizona
city: Walnut Creek
country: United States
facility: Integrated Pain Management Medical Group
state: California
city: Washington
country: United States
facility: International Spine, Pain and Performance Center
state: District of Columbia
city: Shrewsbury
country: United States
facility: Premier Pain Centers
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Richmond
country: United States
facility: Virginia iSpine Physicians
state: Virginia
city: Charleston
country: United States
facility: The Spine and Nerve Center of St. Francis Hospital
state: West Virginia
Study officials:
References:
citation: Deer TR, Gilmore CA, Desai MJ, Li SC, DePalma MJ, Hopkins TJ, Burgher AH, Spinner DA, Cohen SP, McGee MJ, Boggs JW. Percutaneous Peripheral Nerve Stimulation of the Medial Branch Nerves for the Treatment of Chronic Axial Back Pain in Patients After Radiofrequency Ablation. Pain Med. 2021 Mar 18;22(3):548-560. doi: 10.1093/pm/pnaa432.