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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPRINT Peripheral Nerve Stimulation (PNS) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 15 months for each subject from baseline to the last study visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Peoria | Arizona | 85381 | United States | ||
| Integrated Pain Management Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40261580 | Derived | Gilmore CA, Deer TR, Desai MJ, Li S, DePalma MJ, Cohen SP, Swan BD, McGee MJ, Boggs JW. Four-Year Follow-Up from a Prospective, Multicenter Study of Percutaneous 60-Day Peripheral Nerve Stimulation for Chronic Low Back Pain. Pain Ther. 2025 Jun;14(3):1103-1115. doi: 10.1007/s40122-025-00737-3. Epub 2025 Apr 22. | |
| 33616178 | Derived |
| Label | URL |
|---|---|
| Sponsor's Website | View source |
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After obtaining informed consent, subjects were evaluated for eligibility.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Consented Subjects | Subjects who signed an informed consent form. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2019 |
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| 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. | 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. | 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). | 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. | 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. | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
| Walnut Creek |
| California |
| 94598 |
| United States |
| International Spine, Pain and Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| Premier Pain Centers | Shrewsbury | New Jersey | 07702 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Virginia iSpine Physicians | Richmond | Virginia | 23235 | United States |
| The Spine and Nerve Center of St. Francis Hospital | Charleston | West Virginia | 25301 | United States |
| 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. |
| 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. |
|
| Protocol Population | Subjects who were consented, met eligibility criteria, underwent Lead Placement, and continued to meet eligibility criteria. Also includes subjects participating in sub-studies with modified eligibility criteria allowing a history of prior radiofrequency ablation or prior lumbar surgery. |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Duration of Low Back Pain | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Employment Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Protocol Population presented. EOT data were not available for eight subjects. | Posted | Count of Participants | Participants | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
|
|
| ||||||||||||||||||||||||||
| 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. | All enrolled subjects that received leads are presented. | Posted | Count of Participants | Participants | Up to 15 months for each subject from baseline to the last study visit |
|
| |||||||||||||||||||||||||||
| 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. | Protocol Population presented. EOT data were not available for eight subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
|
| ||||||||||||||||||||||||||
| 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. | Protocol Population presented. Data were not available for one subject at baseline and for eight subjects at EOT. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
|
| ||||||||||||||||||||||||||
| 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. | Protocol Population presented. Data were not available for three subjects at baseline and five subjects at end of treatment (EOT). | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
|
| ||||||||||||||||||||||||||
| 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). | Protocol Population presented. EOT data were not available for nine subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
|
| ||||||||||||||||||||||||||
| 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. | Protocol Population presented. EOT data were not available for eight subjects. | Posted | Count of Participants | Participants | 8-weeks post-Start of Treatment (SOT) |
|
| |||||||||||||||||||||||||||
| 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. | Protocol Population presented. Data were not available for nine subjects at end of treatment (EOT). | Posted | Mean | Standard Deviation | score on a scale | Baseline and End of Treatment (EOT= 8-weeks post-start of treatment) |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 99 | 4 | 99 | 49 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shoulder procedure | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
| |
| Heart attack | Cardiac disorders | Systematic Assessment | Not Study-Related |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not Study-Related |
| |
| Heart procedures | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
| |
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not Study-Related |
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| Liver/Lymph node metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not Study-Related |
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| SCS trial and permanent implant | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation at pad and/or Lead exit sites | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
| |
| Irritation or bruising at bandage site or connector cradles | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Mild swelling following Lead removal | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Generalized itching | Skin and subcutaneous tissue disorders | Systematic Assessment | Unable to determine relationship to study |
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| Itching at pad and/or Lead exit sites | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Itching at bandage site | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Discoloration/bruising at Lead exit site | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Discharge or bleeding from electrode/insertion site | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Granuloma | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| Miscellaneous | Skin and subcutaneous tissue disorders | Systematic Assessment | Study-Related |
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| New leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Study-Related |
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| Pain from Lead Placement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Study-Related |
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| Pain/discomfort at lead site | Musculoskeletal and connective tissue disorders | Systematic Assessment | Study-Related |
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| Pain from stimulation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Study-Related |
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| Uncomfortable stimulation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Six events were study-related and two event relationships were unable to be determined. |
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| Worsening low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | One event was study-related, and three events were not related to the study. |
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| Exacerbation of low back pain from medial branch block | Musculoskeletal and connective tissue disorders | Systematic Assessment | Study-Related |
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| Shoulder and/or hip conditions | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not Study-Related |
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| Thoracic pain/hematoma from fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not Study-Related |
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| Pain (distal or unrelated to device location) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Five events were not related to the study and one event relationship was unable to be determined. |
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| Shortness of breath | Cardiac disorders | Systematic Assessment | Not Study-Related |
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| Vasovagal dizziness following lead placement | Cardiac disorders | Systematic Assessment | One event was study-related, and the other relationship was unable to be determined |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment | Not Study-Related |
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| Bacterial pneumonia | General disorders | Systematic Assessment | Not Study-Related |
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| Strep throat | General disorders | Systematic Assessment | Not Study-Related |
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| Sinus infection | General disorders | Systematic Assessment | Not Study-Related |
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| Sinuplasty | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
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| Toenail removal | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
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| Shoulder procedure | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
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| Hip procedure | Surgical and medical procedures | Systematic Assessment | Not Study-Related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | SPR Therapeutics | 216-378-9106 | support@sprtherapeutics.com |
| Jun 14, 2022 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Retired (not due to health) |
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| Homemaker |
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| Unemployed |
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| Student |
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| Disabled and/or Retired Because of Low Back Pain |
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| Other |
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| Participants |
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