Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-12 @ 10:04 PM
Study NCT ID:
NCT03179202
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'support@sprtherapeutics.com', 'phone': '216-378-9106', 'title': 'Clinical Affairs', 'organization': 'SPR Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled/Received Leads', 'description': '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.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 49, 'seriousNumAtRisk': 99, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Irritation at pad and/or Lead exit sites', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritation or bruising at bandage site or connector cradles', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild swelling following Lead removal', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized itching', 'notes': 'Unable to determine relationship to study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching at pad and/or Lead exit sites', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching at bandage site', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discoloration/bruising at Lead exit site', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discharge or bleeding from electrode/insertion site', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Granuloma', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscellaneous', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New leg pain', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain from Lead Placement', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/discomfort at lead site', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain from stimulation', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uncomfortable stimulation', 'notes': 'Six events were study-related and two event relationships were unable to be determined.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening low back pain', 'notes': 'One event was study-related, and three events were not related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of low back pain from medial branch block', 'notes': 'Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder and/or hip conditions', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thoracic pain/hematoma from fall', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain (distal or unrelated to device location)', 'notes': 'Five events were not related to the study and one event relationship was unable to be determined.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal dizziness following lead placement', 'notes': 'One event was study-related, and the other relationship was unable to be determined', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial pneumonia', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Strep throat', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinuplasty', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toenail removal', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder procedure', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip procedure', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Shoulder procedure', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart attack', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart procedures', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melanoma', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver/Lymph node metastases', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SCS trial and permanent implant', 'notes': 'Not Study-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. EOT data were not available for eight subjects.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects That Experienced at Least One Study-Related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled/Received Leads', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 15 months for each subject from baseline to the last study visit', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects that received leads are presented.'}, {'type': 'SECONDARY', 'title': 'Worst Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. EOT data were not available for eight subjects.'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.1', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '12.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. Data were not available for one subject at baseline and for eight subjects at EOT.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Health-Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '13.2', 'spread': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'Role Limitations due to Physical Health', 'categories': [{'measurements': [{'value': '26.6', 'spread': '39.9', 'groupId': 'OG000'}]}]}, {'title': 'Role Limitations due to Emotional Problems', 'categories': [{'measurements': [{'value': '12.2', 'spread': '42.5', 'groupId': 'OG000'}]}]}, {'title': 'Energy/Fatigue', 'categories': [{'measurements': [{'value': '12.8', 'spread': '17.0', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being', 'categories': [{'measurements': [{'value': '7.2', 'spread': '15.2', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '18.0', 'spread': '22.5', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '21.6', 'spread': '20.8', 'groupId': 'OG000'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '5.0', 'spread': '15.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. Data were not available for three subjects at baseline and five subjects at end of treatment (EOT).'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '5.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. EOT data were not available for nine subjects.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Minimally Improved', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Minimally Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8-weeks post-Start of Treatment (SOT)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. EOT data were not available for eight subjects.'}, {'type': 'SECONDARY', 'title': 'Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Protocol Population', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Protocol Population presented. Data were not available for nine subjects at end of treatment (EOT).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Consented Subjects', 'description': 'Subjects who signed an informed consent form.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}]}, {'type': 'Enrolled/Received Leads', 'comment': '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.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'Protocol Population', 'comment': '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.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'Subject Lost to Follow Up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Unrelated Death Reported in All-Cause Mortality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other Reason: Incarceration after Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'After obtaining informed consent, subjects were evaluated for eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled/Received Leads', 'description': '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '13.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Low Back Pain', 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Employment Status', 'classes': [{'title': 'Currently Working', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'On Leave of Absence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Retired (not due to health)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Homemaker', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Student', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Disabled and/or Retired Because of Low Back Pain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-29', 'size': 2599290, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-14T11:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2017-06-01', 'resultsFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-12', 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': '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.'}, {'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', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Worst Pain Intensity', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': "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."}, {'measure': 'Mean Change in Health-Related Quality of Life', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': "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."}, {'measure': 'Beck Depression Inventory (BDI-II)', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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).'}, {'measure': 'Patient Global Impression of Change (PGIC) Survey', 'timeFrame': '8-weeks post-Start of Treatment (SOT)', 'description': '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.'}, {'measure': 'Pain Interference', 'timeFrame': 'Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Electrical Stimulation', 'Neurostimulation', 'Neuromodulation', 'Back Pain', 'Low Back Pain'], 'conditions': ['Back Pain', 'Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '40261580', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33616178', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.sprtherapeutics.com', 'label': "Sponsor's Website"}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* At least 21 years of age\n* Chronic low back pain\n\nKey Exclusion Criteria:\n\n* Infection on or around the low back\n* Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)\n* Implanted electronic device\n* Body Mass Index (BMI) \\> 40\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT03179202', 'briefTitle': 'Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPR Therapeutics, Inc.'}, 'officialTitle': 'A Post-Market Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain', 'orgStudyIdInfo': {'id': '0142-CSP-000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peripheral Nerve Stimulation', 'description': '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.', 'interventionNames': ['Device: SPRINT Peripheral Nerve Stimulation (PNS) System']}], 'interventions': [{'name': 'SPRINT Peripheral Nerve Stimulation (PNS) System', 'type': 'DEVICE', 'otherNames': ['SPRINT System', 'Smartpatch System', 'SPRINT', 'Smartpatch'], 'description': '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.', 'armGroupLabels': ['Peripheral Nerve Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Pain Management Medical Group', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '20006', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'International Spine, Pain and Performance Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '07702', 'city': 'Shrewsbury', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Premier Pain Centers', 'geoPoint': {'lat': 40.32955, 'lon': -74.06153}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia iSpine Physicians', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '25301', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'The Spine and Nerve Center of St. Francis Hospital', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPR Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}