Back Pain, Low Back Pain
Conditions
Keywords
Electrical Stimulation, Neurostimulation, Neuromodulation, Back Pain, Low Back Pain
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).
Interventions
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.
Sponsors
SPR Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
After obtaining informed consent, subjects were evaluated for eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled/Received Leads Subjects who were consented, met eligibility criteria, and underwent Lead placement. Also includes subjects participating in sub-studies with modified eligibility criteria allowing a history of prior radiofrequency ablation or prior lumbar surgery. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Other Reason: Incarceration after Enrollment | 1 |
| Overall Study | Screen Failure | 67 |
| Overall Study | Subject Lost to Follow Up | 12 |
| Overall Study | Unrelated Death Reported in All-Cause Mortality | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Enrolled/Received Leads |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 35 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Age, Continuous | 57.4 years STANDARD_DEVIATION 13.8 |
| Duration of Low Back Pain | 17.2 years STANDARD_DEVIATION 14.7 |
| Employment Status Currently Working | 44 Participants |
| Employment Status Disabled and/or Retired Because of Low Back Pain | 8 Participants |
| Employment Status Homemaker | 4 Participants |
| Employment Status On Leave of Absence | 1 Participants |
| Employment Status Other | 3 Participants |
| Employment Status Retired (not due to health) | 30 Participants |
| Employment Status Student | 2 Participants |
| Employment Status Unemployed | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 99 |
| other Total, other adverse events | 49 / 99 |
| serious Total, serious adverse events | 4 / 99 |
Outcome results
Primary
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)
Population: Protocol Population presented. EOT data were not available for eight subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Protocol Population | Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity | 58 Participants |
Primary
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
Population: All enrolled subjects that received leads are presented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Protocol Population | Number of Subjects That Experienced at Least One Study-Related Adverse Event | 49 Participants |
Secondary
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)
Population: Protocol Population presented. EOT data were not available for nine subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Protocol Population | Beck Depression Inventory (BDI-II) | Baseline | 8.9 score on a scale | Standard Deviation 5.6 |
| Protocol Population | Beck Depression Inventory (BDI-II) | EOT | 5.2 score on a scale | Standard Deviation 5.1 |
Secondary
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)
Population: Protocol Population presented. Data were not available for three subjects at baseline and five subjects at end of treatment (EOT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Protocol Population | Mean Change in Health-Related Quality of Life | Energy/Fatigue | 12.8 score on a scale | Standard Deviation 17 |
| Protocol Population | Mean Change in Health-Related Quality of Life | Emotional well-being | 7.2 score on a scale | Standard Deviation 15.2 |
| Protocol Population | Mean Change in Health-Related Quality of Life | Social Functioning | 18.0 score on a scale | Standard Deviation 22.5 |
| Protocol Population | Mean Change in Health-Related Quality of Life | Pain | 21.6 score on a scale | Standard Deviation 20.8 |
| Protocol Population | Mean Change in Health-Related Quality of Life | General Health | 5.0 score on a scale | Standard Deviation 15.1 |
| Protocol Population | Mean Change in Health-Related Quality of Life | Physical Functioning | 13.2 score on a scale | Standard Deviation 19.6 |
| Protocol Population | Mean Change in Health-Related Quality of Life | Role Limitations due to Physical Health | 26.6 score on a scale | Standard Deviation 39.9 |
| Protocol Population | Mean Change in Health-Related Quality of Life | Role Limitations due to Emotional Problems | 12.2 score on a scale | Standard Deviation 42.5 |
Secondary
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)
Population: Protocol Population presented. Data were not available for one subject at baseline and for eight subjects at EOT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Protocol Population | Oswestry Disability Index (ODI) | Baseline | 39.1 score on a scale | Standard Deviation 12.1 |
| Protocol Population | Oswestry Disability Index (ODI) | EOT | 23.6 score on a scale | Standard Deviation 12.6 |
Secondary
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)
Population: Protocol Population presented. Data were not available for nine subjects at end of treatment (EOT).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Protocol Population | Pain Interference | Baseline | 5.7 score on a scale | Standard Deviation 2 |
| Protocol Population | Pain Interference | EOT | 2.8 score on a scale | Standard Deviation 2 |
Secondary
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)
Population: Protocol Population presented. EOT data were not available for eight subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | Very Much Improved | 12 Participants |
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | Much Improved | 39 Participants |
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | Minimally Improved | 23 Participants |
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | No Change | 8 Participants |
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | Minimally Worse | 0 Participants |
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | Much Worse | 1 Participants |
| Protocol Population | Patient Global Impression of Change (PGIC) Survey | Very Much Worse | 0 Participants |
Secondary
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)
Population: Protocol Population presented. EOT data were not available for eight subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Protocol Population | Worst Pain Intensity | Baseline | 7.7 score on a scale | Standard Deviation 1.2 |
| Protocol Population | Worst Pain Intensity | EOT | 4.5 score on a scale | Standard Deviation 2.1 |