[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416563":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":47,"locations":57,"responsibleParty":77,"collaborators":51,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":51,"enrollmentInfo":91,"targetDuration":51,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":60,"whyStopped":51,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Madigan Army Medical Center","FED",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Therapy (ST)","ACTIVE_COMPARATOR","ST will consist of 975mg of Acetaminophen PO and either 30mg of Ketorolac IM or 15 mg IV. Upon discharge ST will consist of prescriptions for acetaminophen 650mg every 4 hours by mouth, Ibuprofen 400mg every 4 hours by mouth, and 10 mg of cyclobenzaprine nightly by mouth. Additionally, participants will be provided a handout going over these medications and the use of heat for low back pain and instructions on the performance of McKenzie stretching exercises for low back pain.4",[13,14,15],"Drug: Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.","Drug: Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.","Drug: Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.",{"label":17,"type":10,"description":18,"interventionNames":19},"ST plus Trigger Point Injections (TPI) with 8 mL of 0.5 percent Bupivacaine","ST plus TPI with 8 mL of 0.5 percent Bupivacaine",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"ST plus TPI with 8 mL of Normal Saline (NS)","ST plus TPI with 8 mL of Normal Saline",[13,14,15],[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.","We are testing which of the three arms is superior for the treatment of Myofascial Pain Syndrome of the Low Back. Pain will be measured using a 10 cm visual analogue scale (VAS) at baseline and 30-minutes after treatment.",[21,17,9],[31],"Ketorolac, acetaminophen, ibuprofen, cyclobenzaprine, bupivacaine, normal saline",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.","Evaluation of functional ability using a patient centered functional score known as the MODI. The MODI will be scored at baseline and 30-minutes after treatment.",[21,17,9],[31],{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.","60-72 after treatment in the Emergency Department, a member of the study team will follow up with participants to repeat a measurement of pain and functional ability on VAS and MODI respectively. This will be compared to baseline measurements.",[21,17,9],[31],[43],{"name":44,"affiliation":45,"role":46},"Joshua J Oliver, MD","Madigan AMC","PRINCIPAL_INVESTIGATOR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","(360) 393-9024",null,"joshua.j.oliver6.mil@mail.mil",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Kyle S Couperus, MD","(315) 323-2029","kyle.s.couperus.mil@mail.mil",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Department of Emergency Medicine, Madigan Army Medical Center","RECRUITING","Tacoma","Washington","98431","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-122.44429,47.25288,{"lat":70,"lon":69},[73,75],{"name":44,"role":49,"phone":74,"phoneExt":51,"email":52},"360-393-9024",{"name":54,"role":49,"phone":76,"phoneExt":51,"email":56},"(315) 323 2029",{"type":46,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Joshua Oliver","Emergency Medicine Physician \u002F Assistant Research Director Department of Emergency Medicine","100416563","phase-4-trigger-point-injection-for-myofascial-pain-syndrome-in-the-low-back-a-randomized-controlled-trial-100416563",false,"NCT04704297","Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial","Trigger Point Injection for Myofascial Pain Syndrome in the Low Back (T-PIMPS): A Randomized Controlled Trial.","T-PIMPS","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Must have at least 1 trigger point in low back paraspinal muscles.\n3. For exacerbations of chronic low back pain, the pain on presentation must be 1.5 cm above baseline pain on VAS\n\nExclusion Criteria:\n\n1. Allergy or inability to take study medications.\n2. New focal neurologic deficit in lower extremities.\n3. Known active malignancy with bony spinal metastases.\n4. Identifiable spinal, lumbosacral or hip fracture.\n5. History of Fibromyalgia, rheumatoid arthritis, ankylosing spondylitis.\n6. Current use of anticoagulation.\n7. Overlying cellulitis.\n8. Spinal, hip, or pelvic surgery within the past 6 months.\n9. Previous administration of trigger point injections for current episode.\n10. Sciatica-extending down the back of the leg to the heel.\n11. Alternate identifiable cause of participant's acute pain other than myofascial or musculoskeletal pain.\n12. Febrile patients.\n13. Pregnant\n14. Unable to understand English or otherwise unable to provide informed consent (mental handicap, inability to understand instructions, risks, or benefits), or is an at risk population (wounded warrior, resident physicians, prisoners, cadets, midshipmen, or students).",true,"ALL","18 Years",{"count":92,"type":93},180,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of this is direct costs. Previous studies have established the safety of trigger point injections (TPI). However, the results of these studies are highly heterogeneous regarding TPI's ability to treat pain or improve functional outcomes. The two most promising TPI studies conducted in the ED have been published in the last two years. They both suffered from a small sample size. Additionally, they suffered from a combination of limitations including: lack of randomization, inconsistent medical management, lack of a follow-up assessment, and lack of patient centered functional outcomes. These studies were both two armed and either compared standard medical management to TPI with local anesthetic or TPI with local anesthetic to TPI with Normal Saline (NS). One of these studies concluded that TPI is generally beneficial. The other concluded that TPI with NS is superior.\n\nResearch Hypothesis: The investigators hypothesize that standard therapy (ST) plus TPI with 8 mL of 0.5 percent Bupivacaine is superior to ST alone or ST plus TPI with 8 mL of NS for the treatment of the pain associated with MPS of the low back.\n\nSignificance: This will be the first TPI study to compare ST, to TPI with local anesthetic, and TPI with NS for LBP conducted in an ED. It will also be the first TPI study to incorporate a patient centered functional outcome and patient follow-up after discharge from an ED. TPI's are a popular treatment modality for LBP among many Emergency Medicine Providers. However, to date, there is limited evidence for or against it. The investigators are hopeful that this study will answer whether or not trigger point injections are benefiting patients and, if so, which type of TPI is most beneficial.",[99,100],"Low Back Pain","Myofascial Pain Syndrome Lower Back",[102,99,103,104],"Trigger Point Injection","Myofascial Pain Syndrome","Emergency Department","2021-01-09",{"date":107,"type":108},"2021-01-12","ACTUAL",{"date":110,"type":108},"2020-12-28",{"date":112,"type":93},"2022-07-01",{"name":5,"class":6},1]