Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-22 @ 5:49 AM
Study NCT ID:
NCT02391350
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Management Strategies for Patients With Low Back Pain and Sciatica
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D012585', 'term': 'Sciatica'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julie.fritz@utah.edu', 'phone': '8015872237', 'title': 'Dr. Julie Fritz', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 17, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 19, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'back surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'injections', 'notes': 'Spinal injections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 110, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'OG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'classes': [{'title': '4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'groupId': 'OG000', 'lowerLimit': '-11.5', 'upperLimit': '-6.0'}, {'value': '-17.0', 'groupId': 'OG001', 'lowerLimit': '-19.7', 'upperLimit': '-14.2'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'groupId': 'OG000', 'lowerLimit': '-19.9', 'upperLimit': '-14.2'}, {'value': '-22.4', 'groupId': 'OG001', 'lowerLimit': '-25.3', 'upperLimit': '-19.6'}]}]}, {'title': '1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.7', 'groupId': 'OG000', 'lowerLimit': '-20.6', 'upperLimit': '-14.8'}, {'value': '-22.5', 'groupId': 'OG001', 'lowerLimit': '-25.4', 'upperLimit': '-19.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data across follow-up is outlined by group'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Numeric Pain Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'OG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'classes': [{'title': 'Back pain intensity 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.60'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-2.1'}]}]}, {'title': 'Back pain intensity 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '-1.1'}, {'value': '-2.3', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '-1.9'}]}]}, {'title': 'Back pain intensity 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-1.2'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '-2.2'}]}]}, {'title': 'Leg pain intensity 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-0.6'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '-1.4'}]}]}, {'title': 'Leg pain intensity 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '-1.5'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '-1.3'}]}]}, {'title': 'Leg pain intensity 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '-1.3'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '-1.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Separate rating for low back pain and leg pain intensity on a 0-10 scale. Higher numbers indicate greater pain intensity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data reflected across follow-up points'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'OG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'classes': [{'title': 'EQ-5D 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.08'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.15'}]}]}, {'title': 'EQ-5D 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.17'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.19'}]}]}, {'title': 'EQ-5D 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.17'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '0.21'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Self-report measure of Quality of Life. Scores range from 0 - 1.0, with higher scores indicating greater quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data noted across all follow-up points'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Fear-Avoidance Beliefs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'OG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'classes': [{'title': 'Fear-Avoidance Beliefs - physical activity, 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '-2.0'}, {'value': '-4.9', 'groupId': 'OG001', 'lowerLimit': '-6.1', 'upperLimit': '-3.7'}]}]}, {'title': 'Fear-Avoidance Beliefs - physical activity, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'groupId': 'OG000', 'lowerLimit': '-6.1', 'upperLimit': '-3.6'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-6.9', 'upperLimit': '-4.3'}]}]}, {'title': 'Fear-Avoidance Beliefs - physical activity, 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '-2.5'}, {'value': '-7.3', 'groupId': 'OG001', 'lowerLimit': '-8.6', 'upperLimit': '-6.0'}]}]}, {'title': 'Fear-Avoidance Beliefs - work, 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '0.20'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '-1.3'}]}]}, {'title': 'Fear-Avoidance Beliefs - work, 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '-1.4'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-6.8', 'upperLimit': '-3.3'}]}]}, {'title': 'Fear-Avoidance Beliefs - work, 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '-0.90'}, {'value': '-6.2', 'groupId': 'OG001', 'lowerLimit': '-8.0', 'upperLimit': '-4.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': "Fear Avoidance Beliefs about physical activity and work on separate scales. The Fear avoidance about physical activity scale assesses participants' concern that physical activity will harm their back. Scores range from 0-24 with higher scores indicating greater fear of physical activity. The Fear avoidance about work scale assesses participants' concern that work-related activity will harm their back. Scores range from 0-42 with higher scores indicating greater fear of physical activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data noted across follow-up time points'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Pain Catastrophizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'OG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'classes': [{'title': 'Pain catastrophizing - 4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-1.9'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-7.5', 'upperLimit': '-3.7'}]}]}, {'title': 'Pain catastrophizing - 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-8.7', 'upperLimit': '-4.8'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-9.9', 'upperLimit': '-6.1'}]}]}, {'title': 'Pain catastrophizing - 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '-5.9'}, {'value': '-9.0', 'groupId': 'OG001', 'lowerLimit': '-11.0', 'upperLimit': '-7.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Self-reported measure assessing the extent to which a participant experiences catastrophizing cognitions about back pain (e.g., feelings of helplessness, hypervigilance etc.). Scores range from 13-52 with higher numbers indicating greater catastrophizing cognitions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data reflected across time points'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Utilizing Healthcare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'OG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'classes': [{'title': 'Lumbar spine surgery', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Lumbar injections', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Advanced Imaging', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Emergency Department Visit', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'monthly throughout 12 month follow-up period', 'description': 'collected via online diaries', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Health care utilization over 1 year follow-up period. Participants are included in the analyses if at least one monthly utilization report was provided over the 12 month follow-up period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'FG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': '4-week Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': '6-month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'comment': 'One-year follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'Participants were recruited from February 2015 through October, 2018. Recruitment was done in 2 health systems (University of Utah and Intermountain Healthcare) in Salt Lake City, Utah. Potential participants were identified using electronic health records and were sent a letter about the study after completing a primary care visit. A research team made follow-up telephone calls to identify those interested in meeting with a research assistant to determine eligibility and provide consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.'}, {'id': 'BG001', 'title': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.\n\nEducation and re-assurance: Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.\n\nPhysical Therapy: Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '39.0', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age was missing for one participant in the usual care group.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Gender missing for one participant in Early Intervention'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '26.8', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '25.6', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '26.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Duration of symptoms data was missing for one participant in Usual Care at Baseline'}, {'title': 'StartBack Risk Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'title': 'High Risk', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Medium Risk', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Low Risk', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The StartBack Risk Category describes the participant's risk for developing persistent low back pain based on physical and psychological factors. Risk stratification is based on participants' responses to 9 items about their physical and psychological symptom responses.", 'unitOfMeasure': 'Participants'}, {'title': 'Oswestry Disability Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.8', 'spread': '15.8', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure of back pain-related disability. Scores range from 0-100 with higher scores indicating more disability due to low back pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Back Pain Intensity Rating', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant reported back pain intensity of 0-10 scale with higher numbers indicating greater pain intensity.', 'unitOfMeasure': 'units on a 0-10 scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leg Pain Intensity Rating', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant reported intensity of pain in the leg(s) on a 0-10 scale with higher numbers indicating greater pain intensity.', 'unitOfMeasure': 'units on a 0-10 scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Leg pain intensity rating was missing at baseline for one participant in the Early Intervention group.'}, {'title': 'Euroqol 5 Dimensions (EQ-5D)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.20', 'groupId': 'BG000'}, {'value': '0.64', 'spread': '0.20', 'groupId': 'BG001'}, {'value': '0.64', 'spread': '0.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant reported measure of overall quality of life reported on five dimensions (mobility, self-care, depression/anxiety, pain/discomfort, usual activities). Scores range from 0 - 1.0 with higher scores indicating higher level of quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline values were missing for 3 participants in Usual Care and 6 participants in Early Physical Therapy group.'}, {'title': 'Pain Catastrophizing Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '20.9', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '19.9', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant-reported measure of the tendency to magnify the threat value of pain. Scores range from 13-52 with higher scores indicating a higher level of pain catastrophizing.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Pain Catastrophizing Scale was missing at baseline for 2 participants in Usual Care and 3 participants in Early Physical Therapy group.'}, {'title': 'Fear-Avoidance Beliefs - Physical Activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '15.2', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant reported measure of fear that physical activity will harm the back and should be avoided. Scores range from 0-24. Higher scores indicate greater levels of fear about physical activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Fear avoidance beliefs about physical activity data was missing for one participant in usual care group'}, {'title': 'Fear-Avoidance Beliefs - Work', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant reported measure of fear that work-related activities will harm the back and should be avoided. Scores range from 0-42. Higher scores indicate greater levels of fear about work-related activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The Fear Avoidance Beliefs about Work questionnaire was missing for 4 participants in the Early Intervention group and 1 participant in the Usual Care group.'}], 'populationDescription': 'Missing baseline scores; sex (n = 1 EPT), age (n = 1 UC), duration of symptoms (n = 1 UC), Numeric Pain Rating Scale-leg pain intensity (n = 1 EPT), Pain Catastrophizing Scale (n = 3 EPT, n = 2 UC), Fear-Avoidance Beliefs Questionnaire physical activity subscale (n = 1 UC) and work subscale (n = 4 EPT, n = 1 UC), and EQ-5D overall health rating (n = 6 EPT, n = 3 UC).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-27', 'size': 316705, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-06T18:54', 'hasProtocol': True}, {'date': '2020-08-13', 'size': 51463, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-01T04:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2015-01-12', 'resultsFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-01', 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Fear-Avoidance Beliefs', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': "Fear Avoidance Beliefs about physical activity and work on separate scales. The Fear avoidance about physical activity scale assesses participants' concern that physical activity will harm their back. Scores range from 0-24 with higher scores indicating greater fear of physical activity. The Fear avoidance about work scale assesses participants' concern that work-related activity will harm their back. Scores range from 0-42 with higher scores indicating greater fear of physical activity."}, {'measure': 'Change From Baseline in Pain Catastrophizing Scale', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Self-reported measure assessing the extent to which a participant experiences catastrophizing cognitions about back pain (e.g., feelings of helplessness, hypervigilance etc.). Scores range from 13-52 with higher numbers indicating greater catastrophizing cognitions.'}, {'measure': 'Number of Participants Utilizing Healthcare', 'timeFrame': 'monthly throughout 12 month follow-up period', 'description': 'collected via online diaries'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Oswestry Disability Index', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Patient-reported disability due to low back pain. Scores range from 0-100 with higher scores indicating greater disability.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Numeric Pain Ratings', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Separate rating for low back pain and leg pain intensity on a 0-10 scale. Higher numbers indicate greater pain intensity.'}, {'measure': 'Change From Baseline in EQ-5D', 'timeFrame': 'Baseline, 4 weeks, 6 months, 1 year', 'description': 'Self-report measure of Quality of Life. Scores range from 0 - 1.0, with higher scores indicating greater quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Sciatica', 'Physical Therapy']}, 'referencesModule': {'references': [{'pmid': '33017565', 'type': 'DERIVED', 'citation': 'Fritz JM, Lane E, McFadden M, Brennan G, Magel JS, Thackeray A, Minick K, Meier W, Greene T. Physical Therapy Referral From Primary Care for Acute Back Pain With Sciatica : A Randomized Controlled Trial. Ann Intern Med. 2021 Jan;174(1):8-17. doi: 10.7326/M20-4187. Epub 2020 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain and sciatica is a common condition resulting in high costs and disability for society and affected individuals. Presently there is a lack of evidence for what treatments may help this condition early in the course of care. Improved early management could reduce risks for persistent disability and high costs. The goal of this project is to examine the clinical outcomes and costs associated with adding a physical therapy program to early management of patients with low back pain and sciatica within primary care.', 'detailedDescription': 'Low back pain (LBP) is a common and costly condition. When accompanied by sciatica, risks for persistent disability and future invasive treatments increase. Most patients with LBP and sciatica enter the healthcare system in primary care. Optimal primary care management is currently unclear and little data are available to assist clinicians and inform patients of the likely effects of common options. Practice guidelines agree that imaging, spinal injections and surgeries should be reserved for patients whose symptoms do not diminish within 4-8 weeks, yet utilization rates for these procedures are increasing rapidly, partly due to the uncertainty of what options may be offered to patients for initial treatment. Physical therapy is considered an option in the initial management period, but is used inconsistently. It is currently unclear what can be expected from early physical therapy for patients with LBP and sciatica, and what if any long-term effect it may have on clinical outcomes or future healthcare utilization. The investigators research team has conducted a series of clinical trials to clarify the evidence for the most effective physical therapy procedures for patients with LBP and sciatica, and is now in a position to evaluate if the use of early, evidence-based physical therapy can reduce the risk of future disability, healthcare utilization and costs. The proposed study is a randomized trial comparing the effectiveness of usual, guideline-based initial management of newly consulting patients with LBP with sciatica with or without the addition of early physical therapy. Specific aims are to compare the clinical effectiveness, costs (direct and indirect), and cost-effectiveness of the addition of physical therapy. All patients will be managed with advice, education and medication. One group will also receive 6-8 sessions of physical therapy Outcomes will include measures of disability, pain, psychological distress, healthcare, utilization, and costs over 1 year. This study will permit an examination of the effectiveness and costs associated with the use of early physical therapy within primary care for patients with acute LBP and sciatica. The results of this study will provide needed information to assist clinicians and inform patients of their options for initial management of this common condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptoms of pain and/or numbness between the 12th rib and buttocks, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.\n2. Symptoms of pain and/or numbness primarily into one leg that have extended below the knee in the last 72 hours, and correspond to a lower lumbar nerve root distribution (L4, L5, S1)\n3. Current symptoms present for 90 days or fewer\n4. Oswestry disability score \\> 20%\n5. One or more of the following symptoms:\n\n * Positive ipsilateral or contralateral straight leg raise test (reproduction of symptoms at \\<70 degrees)\n * Reflex, sensory, or strength deficits in a pattern consistent with lower lumbar nerve root\n\nExclusion Criteria:\n\n1. Any prior spine fusion surgery, or any surgery to the lumbosacral spine in the past year\n2. Current pregnancy\n3. Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.) or any treatment for LBP in prior 6 months.\n4. Judgment of primary care provider of "red flags" of a potentially serious condition including cauda equina, major or rapidly progressing neurologic deficit, fracture, cancer, infection or systemic disease'}, 'identificationModule': {'nctId': 'NCT02391350', 'briefTitle': 'Management Strategies for Patients With Low Back Pain and Sciatica', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'orgStudyIdInfo': {'id': 'R18HS022641', 'link': 'https://reporter.nih.gov/quickSearch/R18HS022641', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Patients will be managed by primary care provider with a stepped care approach supported by current practice guidelines. Initial management will include education and re-assurance for the first 4 weeks following the primary care visit. Patients in will be recommended to follow-up with their primary care provider if unsatisfied with their progress after 4 weeks. At that time decisions on further treatments and/or referrals will be made by the primary care provider in consultation with the patient consistent with usual care.', 'interventionNames': ['Behavioral: Education and re-assurance']}, {'type': 'EXPERIMENTAL', 'label': 'Early Intervention', 'description': 'Patients will receive education and re-assurance in the same manner as the usual care group and will receive physical therapy during the initial 4 weeks following enrollment. Physical therapy will be based on evidence and prior research evaluating a centralizing treatment program for patients with LBP and sciatica. The first physical therapy session will be scheduled within 3 days after enrollment and 6-8 sessions will be administered in the first 4 weeks. Each session will include a brief assessment, treatment with centralizing exercises and spinal mobilizations. Mechanical traction is an optional component. Patients will be provided handouts and instructed to perform assigned exercises at home every 4-5 hours on days between sessions.', 'interventionNames': ['Behavioral: Education and re-assurance', 'Procedure: Physical Therapy']}], 'interventions': [{'name': 'Education and re-assurance', 'type': 'BEHAVIORAL', 'description': 'Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.', 'armGroupLabels': ['Early Intervention', 'Usual Care']}, {'name': 'Physical Therapy', 'type': 'PROCEDURE', 'description': 'Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.', 'armGroupLabels': ['Early Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The University of Utah Healthcare System', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Julie Fritz', 'investigatorAffiliation': 'University of Utah'}}}}