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

Not Applicable

Completed

Conditions: Back Pain
Low Back Pain

Interventions: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Registration Number: NCT03179202

Lead Sponsor: SPR Therapeutics, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 166

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Stimulation	SPRINT Peripheral Nerve Stimulation (PNS) System	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity	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	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 Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) Survey	8-weeks post-Start of Treatment (SOT)	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.
Mean Change in Health-Related Quality of Life	Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)	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.
Worst Pain Intensity	Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)	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.
Oswestry Disability Index (ODI)	Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)	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.
Pain Interference	Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)	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.
Beck Depression Inventory (BDI-II)	Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)	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).

Trial Locations

Locations (8): Virginia iSpine Physicians
🇺🇸
Richmond, Virginia, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Integrated Pain Management Medical Group
🇺🇸
Walnut Creek, California, United States
Hope Research Institute
🇺🇸
Peoria, Arizona, United States
Premier Pain Centers
🇺🇸
Shrewsbury, New Jersey, United States
International Spine, Pain and Performance Center
🇺🇸
Washington, District of Columbia, United States
Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
The Spine and Nerve Center of St. Francis Hospital
🇺🇸
Charleston, West Virginia, United States