An interventional study of SPRINT Peripheral Nerve Stimulation (PNS) System in Back Pain and Low Back Pain, sponsored by SPR Therapeutics, Inc.. Completed at 8 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by SPR Therapeutics, Inc. (part of Medtronic) · Not applicable, Interventional, and Treatment
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).
2,389 studies on the registry are indexed under Back Pain; 282 are open to participants now.
This study's enrollment of 166 is above the median of 60 across 1,952 interventional studies indexed under Back Pain.
Browse Back Pain studies →SPR Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted before SPR Therapeutics, Inc. became part of Medtronic.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Device: SPRINT Peripheral Nerve Stimulation (PNS) System
The SPRINT PNS System is a device which delivers mild electrical stimulation to the muscles 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). The PNS System was approved by the FDA for up to 60 days of use for the management of acute and chronic pain, including back pain.
Also known as: SPRINT System, Smartpatch System, SPRINT, Smartpatch
Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
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.
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Number of Subjects That Experienced at Least One Study-Related Adverse Event
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.
Time frame: Up to 15 months for each subject from baseline to the last study visit
Worst Pain Intensity
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.
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Oswestry Disability Index (ODI)
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.
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Mean Change in Health-Related Quality of Life
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.
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Beck Depression Inventory (BDI-II)
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).
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Patient Global Impression of Change (PGIC) Survey
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.
Time frame: 8-weeks post-Start of Treatment (SOT)
Pain Interference
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.
Time frame: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
Recruitment began in June 2017 and was concluded in December 2019. Subjects were screened from the available pool of candidates who presented with chronic low back pain.
| Milestone | Consented Subjects |
|---|---|
| Started | 166 |
| Enrolled/received leads | 99 |
| Protocol population | 91 |
| Completed | 75 |
| Not completed | 91 |
| Withdrew: Screen failure | 67 |
| Withdrew: Subject lost to follow up | 12 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Adverse event | 3 |
| Withdrew: Unrelated death reported in all-cause mortality | 1 |
| Withdrew: Other reason: incarceration after enrollment | 1 |
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.
| Participants | Protocol Population |
|---|---|
| Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity | 58 |
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.
| Participants | Enrolled/Received Leads |
|---|---|
| Number of Subjects That Experienced at Least One Study-Related Adverse Event | 49 |
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.
| score on a scale | Protocol Population |
|---|---|
| Baseline | 7.7 ± 1.2 |
| EOT | 4.5 ± 2.1 |
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.
| score on a scale | Protocol Population |
|---|---|
| Baseline | 39.1 ± 12.1 |
| EOT | 23.6 ± 12.6 |
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.
| score on a scale | Protocol Population |
|---|---|
| Physical Functioning | 13.2 ± 19.6 |
| Role Limitations due to Physical Health | 26.6 ± 39.9 |
| Role Limitations due to Emotional Problems | 12.2 ± 42.5 |
| Energy/Fatigue | 12.8 ± 17.0 |
| Emotional well-being | 7.2 ± 15.2 |
| Social Functioning | 18.0 ± 22.5 |
| Pain | 21.6 ± 20.8 |
| General Health | 5.0 ± 15.1 |
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).
| score on a scale | Protocol Population |
|---|---|
| Baseline | 8.9 ± 5.6 |
| EOT | 5.2 ± 5.1 |
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.
| Participants | Protocol Population |
|---|---|
| Very Much Improved | 12 |
| Much Improved | 39 |
| Minimally Improved | 23 |
| No Change | 8 |
| Minimally Worse | 0 |
| Much Worse | 1 |
| Very Much Worse | 0 |
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.
| score on a scale | Protocol Population |
|---|---|
| Baseline | 5.7 ± 2.0 |
| EOT | 2.8 ± 2.0 |
Collected over Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 14 months for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled/Received Leads | 1/99 (1%) | 4/99 (4%) | 49/99 (49.5%) |
| Event | Enrolled/Received Leads |
|---|---|
| Shoulder procedureSurgical and medical procedures | 1/99 |
| Heart attackCardiac disorders | 1/99 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/99 |
| Heart proceduresSurgical and medical procedures | 1/99 |
| MelanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/99 |
| Liver/Lymph node metastasesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/99 |
| SCS trial and permanent implantSurgical and medical procedures | 1/99 |
| Event | Enrolled/Received Leads |
|---|---|
| Irritation or bruising at bandage site or connector cradlesSkin and subcutaneous tissue disorders | 19/99 |
| Irritation at pad and/or Lead exit sitesSkin and subcutaneous tissue disorders | 16/99 |
| Itching at bandage siteSkin and subcutaneous tissue disorders | 13/99 |
| Itching at pad and/or Lead exit sitesSkin and subcutaneous tissue disorders | 11/99 |
| Uncomfortable stimulationMusculoskeletal and connective tissue disorders | 8/99 |
| Pain (distal or unrelated to device location)Musculoskeletal and connective tissue disorders | 6/99 |
| Pain/discomfort at lead siteMusculoskeletal and connective tissue disorders | 5/99 |
| Worsening low back painMusculoskeletal and connective tissue disorders | 4/99 |
| Discharge or bleeding from electrode/insertion siteSkin and subcutaneous tissue disorders | 3/99 |
| Pain from Lead PlacementMusculoskeletal and connective tissue disorders | 3/99 |
| Age, Categorical(Participants) | Enrolled/Received Leads |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 64 |
| >=65 years | 35 |
| Age, Continuous(years) | Enrolled/Received Leads |
|---|---|
| Mean | 57.4 ± 13.8 |
| Sex: Female, Male(Participants) | Enrolled/Received Leads |
|---|---|
| Female | 50 |
| Male | 49 |
| Ethnicity (NIH/OMB)(Participants) | Enrolled/Received Leads |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 97 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Enrolled/Received Leads |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 12 |
| White | 84 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Enrolled/Received Leads |
|---|---|
| United States | 99 |
| Duration of Low Back Pain(years) | Enrolled/Received Leads |
|---|---|
| Mean | 17.2 ± 14.7 |
| Employment Status(Participants) | Enrolled/Received Leads |
|---|---|
| Currently Working | 44 |
| On Leave of Absence | 1 |
| Retired (not due to health) | 30 |
| Homemaker | 4 |
| Unemployed | 7 |
| Student | 2 |
| Disabled and/or Retired Because of Low Back Pain | 8 |
| Other | 3 |
Documents are hosted by the registry — open the source record to download them.
Ran from Jun 2017 to primary completion in May 2021, 46 months.
Results were first posted in Aug 2022, 1 year 2 months after primary completion.
Of 64 industry-sponsored interventional studies with no phase under Back Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 25. This study's 46 months is above that.
Counting every sponsor, half of 997 studies reached it within 11 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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