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The protocol outlines objectives, background rationale, study design, subject selection criteria, and intervention plans combining drug treatment (including tramadol and placebo with rescue medication) and a behavioral component (CBT for fibromyalgia and health education). It specifies assessment schedules, evaluation methods, adverse experience management, intervention discontinuation criteria, and statistical and monitoring considerations, including human subjects protections and publication rules.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/combined-behavioral-analgesic-trial-for-fibromyalgia-combat-fm-protocol/396202/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/combined-behavioral-analgesic-trial-for-fibromyalgia-combat-fm-protocol/396202.png","ImageObject",300,407,{"name":92,"@type":93},"kopisore","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-04","2026-09-26",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What is COMBAT-FM and who sponsors the study?","Question",{"text":113,"@type":114},"COMBAT-FM is the Combined Behavioral & Analgesic Trial for Fibromyalgia. It is supported by the National Institutes of Health, NIAMS grant #1R01AR059102-01A1.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What interventions are included in the trial?",{"text":118,"@type":114},"The protocol includes a drug intervention with tramadol, placebo, rescue medication, and a medication treatment/distribution plan. 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Turk, PhD  \nJohn and Emma Bonica Professor of Anesthesiology & Pain Research  \nUniversity of Washington School of Medicine  \nPrincipal Investigators:  \nJames P. Robinson, MD, PhD  \nAssociate Professor of Rehabilitation Medicine  \nUniversity of Washington School of Medicine  \nRobert H. Dworkin, PhD  \nProfessor of Anesthesiology, Neurology, Oncology, and Psychiatry  \nUniversity of Rochester School of Medicine and Dentistry  \nStudy Biostatistician:  \nMarcia A. Ciol, PhD  \nResearch Associate Professor, Department of Rehabilitation Medicine  \nUniversity of Washington School of Medicine  \nSupported By:  \nThe National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) grant \\#1R01AR059102-01A1 .  \nCONFIDENTIALITY STATEMENT  \nThis document is a confidential communication of the University of Washington/NIAMS. The recipient agrees that no information contained herein will be published or disclosed without written approval. This document may be disclosed to appropriate institutional review boards, Data Safety and Monitoring Board, independent ethics committees, or duly authorized representatives of the U.S. Food and Drug Administration, or other regulatory authorities as appropriate, under the condition that confidentiality is requested.  \nINVESTIGATOR’S AGREEMENT  \nCombined Behavioral & Analgesic Trial For Fibromyalgia (COMBAT-FM)  \nProtocol Approval Date:    \nI have carefully read the COMBAT-FM protocol and agree that it contains all the necessary information for conducting this study safely. I will conduct this study in strict accordance with this protocol and will attempt to complete the study within the time designated. I will provide copies of the protocol and all other information relating to pre-clinical and prior clinical experience to all personnel responsible to me who participate in the study. I will discuss this information with them to assure that they are adequately informed regarding the medication and conduct of the study. I agree to keep records on all subject information (case report forms, shipment and medication return forms and all other information collected during the study) in accordance with Good Clinical Practice and local regulations.  \n___ _________  \n3/1/12  \nInvestigator’s signature Date:  \nPrinted name: Dennis C. Turk , PhD   \nTitle:  John and Emma Bonica Professor ofAnesthesiology & Pain Research   \nAddress:  Department of Anesthesiology & Pain Medicine   Box 356540   \n University of Washington  Seattle, Wasjhington 98195  \n__ ____________  \nPhone No.:  (206) 616-2626   \nTABLE OF CONTENTS 3  \nABBREVIATIONS USED IN PROTOCOL 5  \nCLINICAL SITES PARTICIPATING IN THE STUDY 6  \nSTUDY TEAM ROSTER 6  \nPRÉCIS 11  \nSTUDY PROTOCOL 13  \n1.  OBJECTIVES 13  \n1. Primary Objective 13  \n2. Secondary Objectives 13  \n2.  BACKGROUND 13  \n1. Statement of the Problem 13  \n2. Rationale and Supporting Data 14  \n3.  STUDY DESIGN 16  \n4.  SELECTION AND ENROLLMENT OF SUBJECTS 16  \n1. Inclusion Criteria 16  \n2. Exclusion Criteria 17  \n3. Study Enrollment Procedures 17  \n5.  STUDY INTERVENTIONS 18  \n1. Drug Intervention 18  \n1. Tramadol 19  \n2. Placebo 19  \n3. Rescue Medication 20  \n4. Medication Treatment Protocol 20  \n5. Medication Distribution , Storage, and Accountability 21  \n6. Blinding and Unblinding of Study Medication 22  \n2. Behavioral Intervention 22  \n1. CBTfm 23  \n2. Health Education 23  \n6.  STUDY EVALUATIONS AND ASSESSMENTS 26  \n1. Schedule and Timing of Assessments 26  \n2. Description of Evaluations and Assessments 32  \n1. Patient Self-reported Outcomes 32  \n2. Clinician Evaluations 33  \n3. Actigraphy 34  \n4. Central Sensitization 35  \n5. Research Staff Procedures 36  \n1. Recruitment 36  \n2. Prescreening 36  \n3. Medication Log and Adherence 36  \n3. Compensation 36  \n7. ADVERSE EXPERIENCES ASSOCIATED WITH STUDY MEDICATIONS 37  \n8.  CRITERIA FOR INTER","cbCaijU8zBFjj7D4","https://ap.wps.com/l/cbCaijU8zBFjj7D4","pdf",635932,54,"English","# Table of Contents\n## Abbreviations Used in Protocol\n## Clinical Sites Participating in the Study\n## Study Team Roster\n## Précis\n## Study Protocol\n## 1. Objectives\n## 2. Background\n## 3. Study Design\n## 4. Selection and Enrollment of Subjects\n## 5. Study Interventions\n## 6. Study Evaluations and Assessments\n## 7. Adverse Experiences Associated with Study Medications\n## 8. Criteria for Intervention Discontinuation\n## 9. Statistical Considerations\n## 10. Data Collection, Site Monitoring, Adverse Events\n## 11. Human Subjects\n## 12. Publication of Research Findings\n## References","[{\"question\":\"What is COMBAT-FM and who sponsors the study?\",\"answer\":\"COMBAT-FM is the Combined Behavioral \\u0026 Analgesic Trial for Fibromyalgia. It is supported by the National Institutes of Health, NIAMS grant #1R01AR059102-01A1.\"},{\"question\":\"What interventions are included in the trial?\",\"answer\":\"The protocol includes a drug intervention with tramadol, placebo, rescue medication, and a medication treatment/distribution plan. It also includes a behavioral intervention with CBT for fibromyalgia (CBTfm) and health education.\"},{\"question\":\"How does the protocol handle safety, adverse experiences, and study discontinuation?\",\"answer\":\"It defines adverse experiences associated with study medications, provides criteria for intervention discontinuation, and includes data collection and site monitoring processes for adverse event reporting.\"}]","COMBINED BEHAVIORAL & ANALGESIC TRIAL FOR FIBROMYALGIA (COMBAT-FM) - Protocol | PDF",1790434875,136]