Nctid:
NCT06229834
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008881", "term"=>"Migraine Disorders"}], "ancestors"=>[{"id"=>"D051270", "term"=>"Headache Disorders, Primary"}, {"id"=>"D020773", "term"=>"Headache Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M9351", "name"=>"Headache", "relevance"=>"LOW"}, {"id"=>"M11852", "name"=>"Migraine Disorders", "asFound"=>"Migraine", "relevance"=>"HIGH"}, {"id"=>"M22529", "name"=>"Headache Disorders", "relevance"=>"LOW"}, {"id"=>"M26657", "name"=>"Headache Disorders, Primary", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"While participants, treating chiropractors, study coordinators, and research assistants will be unblinded to treatment assignment, study investigators who are not involved in providing chiropractic care treatments or monitoring adverse events will be blinded. The blinding of these investigators and the programmer will only be broken after approval of the final statistical analysis plan and locking of the trial data."}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"A two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial (Osher Clinic, BWH, and VA Medical Center, West Haven, CT). We will recruit and randomize 60 individuals (30 per site). Individuals will be randomized (1:1) to: 1) 14 sessions of CC (6 sessions of chiropractic care over 3 weeks followed by 8 sessions of chiropractic care (CC) over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine-specific topics) - both added to usual medical care. Individuals will be followed for 4 weeks after the end of their intervention period."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2027-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-01", "studyFirstSubmitDate"=>"2024-01-12", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Recruitment feasibility (average number of participants per month)", "timeFrame"=>"16 months", "description"=>"Each site will be able to recruit 30 participants within 16 months"}, {"measure"=>"Retention feasibility (proportion of participants not lost to follow-up)", "timeFrame"=>"20 weeks", "description"=>"Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment."}, {"measure"=>"Intervention adherence feasibility", "timeFrame"=>"15 weeks", "description"=>"Adherence will be calculated as the proportion of subjects who attend at least 80% of the chiropractic care visits or 80% of the one-on-one headache health education video-conferences."}, {"measure"=>"Number of days with migraine headaches", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Number of migraine headaches as recorded in migraine diaries; this will be the primary clinical outcome."}], "secondaryOutcomes"=>[{"measure"=>"Proportion of responders", "timeFrame"=>"Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).", "description"=>"Proportion of individuals who experience a ≥50% reduction in migraine days."}, {"measure"=>"Average severity of migraine attacks", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Average severity of migraine attacks (on a 1 to 10 scale) as recorded in migraine diaries."}, {"measure"=>"Average number of hours for a migraine attack (duration)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Average number of hours a migraine attack lasted as recorded in migraine diaries."}, {"measure"=>"Average number of medications used for a migraine attack", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Average number of medications used to treat a migraine attack as recorded in migraine diaries"}, {"measure"=>"Neck Disability Index (NDI)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Self-report questionnaire used to determine how neck pain impacts daily activities of living and self-related neck pain disability.\n\nScore range: 10 - 60. Higher scores indicate greater disability."}, {"measure"=>"Headache Related Disability (HIT-6)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"HIT-6 is a validated 6-item assessment that evaluates the impact headaches have on a participant's life. Score range: 36 - 78. Higher scores indicate greater disability."}, {"measure"=>"Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1) is a validated 14-item questionnaire; it is one of the most frequently used disability instrument in migraine research and is highly reliable.\n\nParticipants are asked to provide their response to each question using a standard six point Likert-type scale (none of the time; a little bit of the time; some of the time; a good bit of the time; most of the time; all of the time). Each MSQoL v.2.1 dimension is scored independently from 0 to 100 such that a higher score indicates a better quality of life."}, {"measure"=>"Patient-Reported Outcomes Measurement Information System (PROMIS-29)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"PROMIS-29 is a system of validated, highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being.\n\nPROMIS-29 v2. 0 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score."}, {"measure"=>"PTSD Checklist for DSM-5 (PCL-5)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"20-item self-report measure of the DSM-5 symptoms of PTSD. Score range: 0 - 5. Higher scores are associated with greater likelihood of PTSD."}, {"measure"=>"Godin Leisure-Time Exercise Questionnaire (GLTEQ)", "timeFrame"=>"Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.", "description"=>"Godin Leisure-Time Exercise Questionnaire will be used to measure the amount and intensity of general exercise during the study period. This validated instrument consists of 4 items measuring the frequency of light, moderate, and vigorous-intensity leisure-time physical activity. In the GLTEQ, individuals are asked to complete a self-explanatory, brief four-item query of usual leisure-time exercise habits.\n\nHigher score indicate more leisure-time exercise per week."}, {"measure"=>"The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)", "timeFrame"=>"Assess only at baseline following the 4 weeks run-in phase but before randomization.", "description"=>"EXPECT Questionnaire (short form) is a recently developed and validated questionnaire used to assess individuals' expectations of treatments for chronic pain.\n\nScore range: 0 - 40. Higher scores indicate higher expectation of recovery after treatment."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["migraine", "headache disorder"], "conditions"=>["Episodic Migraine"]}, "referencesModule"=>{"references"=>[{"pmid"=>"30918090", "type"=>"BACKGROUND", "citation"=>"Albrecht DS, Mainero C, Ichijo E, Ward N, Granziera C, Zurcher NR, Akeju O, Bonnier G, Price J, Hooker JM, Napadow V, Loggia ML, Hadjikhani N. Imaging of neuroinflammation in migraine with aura: A [11C]PBR28 PET/MRI study. Neurology. 2019 Apr 23;92(17):e2038-e2050. doi: 10.1212/WNL.0000000000007371. Epub 2019 Mar 27."}, {"pmid"=>"17000975", "type"=>"BACKGROUND", "citation"=>"Arnold M, Kappeler L, Georgiadis D, Berthet K, Keserue B, Bousser MG, Baumgartner RW. Gender differences in spontaneous cervical artery dissection. Neurology. 2006 Sep 26;67(6):1050-2. doi: 10.1212/01.wnl.0000237341.30854.6a."}, {"pmid"=>"24853166", "type"=>"BACKGROUND", "citation"=>"Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22."}, {"pmid"=>"31919834", "type"=>"BACKGROUND", "citation"=>"Beaton-Starr M, Rist PM, Connor JP, Wayne PM, Osypiuk K, Bernstein C. Development and Implementation of the Integrative Toolbox for Headache Management. Headache. 2020 Apr;60(4):771-775. doi: 10.1111/head.13743. Epub 2020 Jan 9."}, {"pmid"=>"31223518", "type"=>"BACKGROUND", "citation"=>"Befus DR, Hull S, Strand de Oliveira J, Schmidler GS, Weinberger M, Coeytaux RR. Nonpharmacological Self-Management of Migraine Across Social Locations: An Equity-Oriented, Qualitative Analysis. Glob Adv Health Med. 2019 Jun 13;8:2164956119858034. doi: 10.1177/2164956119858034. eCollection 2019."}, {"pmid"=>"30944771", "type"=>"BACKGROUND", "citation"=>"Bernstein C, Wayne PM, Rist PM, Osypiuk K, Hernandez A, Kowalski M. Integrating Chiropractic Care Into the Treatment of Migraine Headaches in a Tertiary Care Hospital: A Case Series. Glob Adv Health Med. 2019 Mar 28;8:2164956119835778. doi: 10.1177/2164956119835778. eCollection 2019."}, {"pmid"=>"33431279", "type"=>"BACKGROUND", "citation"=>"Connor JP, Bernstein C, Kilgore K, Rist PM, Osypiuk K, Kowalski M, Wayne PM. Perceptions of Chiropractic Care Among Women With Migraine: A Qualitative Substudy Using a Grounded-Theory Framework. J Manipulative Physiol Ther. 2021 Feb;44(2):154-163. doi: 10.1016/j.jmpt.2020.07.001. Epub 2021 Jan 9."}, {"pmid"=>"27288324", "type"=>"BACKGROUND", "citation"=>"Lisi AJ, Brandt CA. Trends in the Use and Characteristics of Chiropractic Services in the Department of Veterans Affairs. J Manipulative Physiol Ther. 2016 Jun;39(5):381-386. doi: 10.1016/j.jmpt.2016.04.005."}, {"pmid"=>"33050719", "type"=>"BACKGROUND", "citation"=>"Rist PM, Bernstein C, Kowalski M, Osypiuk K, Connor JP, Vining R, Long CR, Macklin EA, Wayne PM. Multimodal chiropractic care for migraine: A pilot randomized controlled trial. Cephalalgia. 2021 Mar;41(3):318-328. doi: 10.1177/0333102420963844. Epub 2020 Oct 13."}, {"pmid"=>"30971484", "type"=>"BACKGROUND", "citation"=>"Rist PM, Buring JE, Ridker PM, Kase CS, Kurth T, Rexrode KM. Lipid levels and the risk of hemorrhagic stroke among women. Neurology. 2019 May 7;92(19):e2286-e2294. doi: 10.1212/WNL.0000000000007454. Epub 2019 Apr 10."}, {"pmid"=>"30973196", "type"=>"BACKGROUND", "citation"=>"Rist PM, Hernandez A, Bernstein C, Kowalski M, Osypiuk K, Vining R, Long CR, Goertz C, Song R, Wayne PM. The Impact of Spinal Manipulation on Migraine Pain and Disability: A Systematic Review and Meta-Analysis. Headache. 2019 Apr;59(4):532-542. doi: 10.1111/head.13501. Epub 2019 Mar 14."}, {"pmid"=>"32043014", "type"=>"BACKGROUND", "citation"=>"Wayne PM, Bernstein C, Kowalski M, Connor JP, Osypiuk K, Long CR, Vining R, Macklin E, Rist PM. The Integrative Migraine Pain Alleviation through Chiropractic Therapy (IMPACT) trial: Study rationale, design and intervention validation. Contemp Clin Trials Commun. 2020 Jan 22;17:100531. doi: 10.1016/j.conctc.2020.100531. eCollection 2020 Mar."}, {"pmid"=>"20193083", "type"=>"BACKGROUND", "citation"=>"Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40."}, {"pmid"=>"28694204", "type"=>"BACKGROUND", "citation"=>"Wayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8."}, {"pmid"=>"23026349", "type"=>"BACKGROUND", "citation"=>"Wayne PM, Manor B, Novak V, Costa MD, Hausdorff JM, Goldberger AL, Ahn AC, Yeh GY, Peng CK, Lough M, Davis RB, Quilty MT, Lipsitz LA. A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial. Contemp Clin Trials. 2013 Jan;34(1):21-34. doi: 10.1016/j.cct.2012.09.006. Epub 2012 Sep 29."}]}, "descriptionModule"=>{"briefSummary"=>"Migraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.", "detailedDescription"=>"Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints.\n\nOur long-term goal is to conduct a multi-site large-scale, fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability.\n\nTo help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine specific topics) - both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess the fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Migraine frequency between 4 to 13 days per month during a four week run-in period, and with a history of migraines dating for at least one year;\n* Stable use of behavioral interventions or, if not currently using behavioral interventions, agree to not begin new behavioral interventions during this trial;\n* Be willing to complete all study procedures and be randomized to all intervention groups;\n* Be fluent in English.\n\nExclusion Criteria:\n\n* Any major systemic illness or unstable medical condition (e.g. Parkinson's disease, cancer) or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol;\n* History of stroke, carotid artery dissection, or vertebral artery dissection;\n* Signs of myelopathy or carotid bruits or evidence of hypermobility during the clinical exam;\n* Head or neck trauma within the past year;\n* Current alcohol or substance abuse (self-reported);\n* Diagnosis of medication overuse headache (International 3rd Classification of Headache Disorders-edition);\n* Currently or recently (past 6 months) received Botox treatment for migraine;\n* Currently or recently received chiropractic care (past 3 months) for any condition;\n* Failure to complete baseline migraine logs use during run-in phase."}, "identificationModule"=>{"nctId"=>"NCT06229834", "briefTitle"=>"Chiropractic Care for Episodic Migraine", "organization"=>{"class"=>"OTHER", "fullName"=>"Brigham and Women's Hospital"}, "officialTitle"=>"Chiropractic Care for Episodic Migraine", "orgStudyIdInfo"=>{"id"=>"2023P003554"}, "secondaryIdInfos"=>[{"id"=>"R01AT012228-01", "link"=>"https://reporter.nih.gov/quickSearch/R01AT012228-01", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Chiropractic Care", "description"=>"4 sessions of chiropractic care (6 sessions of chiropractic care over 3 weeks followed by 8 sessions of chiropractic care over 12 weeks); participants will be allowed to continue usual care throughout the study.", "interventionNames"=>["Procedure: Chiropractic Care"]}, {"type"=>"OTHER", "label"=>"Headache Health Education (HHE)", "description"=>"Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.", "interventionNames"=>["Behavioral: Headache Health Education"]}], "interventions"=>[{"name"=>"Chiropractic Care", "type"=>"PROCEDURE", "description"=>"The chiropractic care protocol can be personalized to the patient's clinical needs and follows the scope of chiropractic care practice in the Commonwealth of Massachusetts and the State of Connecticut. Components of the chiropractic intervention include: posture correction / spinal stabilization exercises; soft tissue relaxation techniques; spinal manipulation (i.e. chiropractic adjustment) / mobilization; breathing and relaxation techniques; stretches, self-care; ergonomic modifications; bracing and supports.", "armGroupLabels"=>["Chiropractic Care"]}, {"name"=>"Headache Health Education", "type"=>"BEHAVIORAL", "description"=>"Material to be covered will focus on pre-defined migraine specific topics including materials we have previously used in a popular Osher Clinical Center patient education program called the Migraine Toolkit. Sessions will be delivered by trained research assistants and will utilize publicly available short videos followed by scripted discussions with the participant. Participants will be allowed to continue usual care throughout the study.", "armGroupLabels"=>["Headache Health Education (HHE)"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Pamela M Rist, ScD", "role"=>"CONTACT", "email"=>"prist@mail.harvard.edu", "phone"=>"617-278-0835"}, {"name"=>"Dennis Muñoz-Vergara, PhD", "role"=>"CONTACT", "email"=>"dmunozvergara@bwh.harvard.edu", "phone"=>"617-278-0917"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"As this pilot study is a randomized trial, unblinded data involving the randomized treatments will be shared after the locking of the study database and the dissemination of the main trial findings. As done with other trials in the Division of Preventive Medicine at Brigham and Women's Hospital, new research collaborations will be encouraged that make use of the data collected during this trial. Investigators interested in using data from this trial will be directed to contact the multiple principle investigators for data access.\n\nAt all times, we are fully cognizant of and will scrupulously follow the guidelines of the Health Insurance Portability and Accountability Act (HIPAA), to ensure that participants' rights and confidentiality are not compromised."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Brigham and Women's Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Palmer College of Chiropractic", "class"=>"OTHER"}, {"name"=>"Yale University", "class"=>"OTHER"}, {"name"=>"VA Connecticut Healthcare System", "class"=>"FED"}, {"name"=>"National Center for Complementary and Integrative Health (NCCIH)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor of Medicine", "investigatorFullName"=>"Peter M. Wayne, Ph.D.", "investigatorAffiliation"=>"Brigham and Women's Hospital"}}}}
