[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602583":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":47,"locations":57,"responsibleParty":71,"collaborators":41,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":41,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":41,"enrollmentInfo":83,"targetDuration":41,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":100,"whyStopped":41,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Quiropraxia y Equilibrio","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"LLLT-AT","EXPERIMENTAL","Participants will receive low-level laser auriculotherapy (LLLT-AT) using an infrared class IIIb diode laser (905 nm). The laser will be applied to four auricular acupuncture points: Shenmen (TF4), Kidney (AH9), Liver (AH11), and Point Zero (O'), following the protocol by Marques et al. (2023). Each point will receive 4 J of energy (total of 16 J per session) with an average output power of 71 mW over 224 seconds. The treatment will be applied to the auricle ipsilateral to the symptomatic TMJ or to the more painful side in bilateral cases. In addition to LLLT-AT, the experimental group will receive a baseline manual therapy treatment consisting of bilateral myofascial release of the masseter and temporalis muscles. A total of six sessions will be delivered over a period of three weeks.",[13,14],"Radiation: Low-level laser auriculotherapy (LLLT-AT)","Other: Myofascial release",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham LLLT-AT","SHAM_COMPARATOR","Participants in the sham laser group will be treated under the same conditions as the experimental group, using the same device (COMBI 400L, Gymna®), dosage parameters, and safety procedures. However, a simulated laser emission will be used by disconnecting the probe, thereby preventing the laser beam from being emitted. The laser will be applied to the same four auricular points as in the experimental group. This sham condition is unlikely to be perceived by participants, as low-level laser therapy is athermal and does not produce noticeable sensations during application. In addition to sham LLLT-AT, this group will receive a baseline manual therapy treatment consisting of bilateral myofascial release of the masseter and temporalis muscles. A total of six sessions will be delivered over a period of three weeks.",[20,14],"Other: Sham Low-level laser auriculotherapy (sham LLLT-AT)",[22,30,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Low-level laser auriculotherapy (LLLT-AT)","Low-Level Laser Auriculotherapy (LLLT-AT) is a non-invasive, painless treatment that applies infrared laser (class IIIb, 905 nm) to specific auricular acupuncture points. It aims to reduce musculoskeletal pain and anxiety by stimulating mitochondrial cytochrome c oxidase, increasing ATP production, promoting tissue repair, and modulating inflammation. LLLT also reduces nerve excitability and triggers β-endorphin release, aiding in pain control. Auricular stimulation may influence autonomic nervous system activity, impacting both physical and emotional symptoms. The intervention consists of two sessions per week over three weeks, following standard laser safety procedures.",[9],[28,29],"Laser Auriculotherapy","Auricular Photobiomodulation Therapy",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Sham Low-level laser auriculotherapy (sham LLLT-AT)","Sham LLLT-AT replicates the active procedure using the same laser device and parameters, but without light emission. The probe will be deactivated and applied to the same auricular points twice weekly for three weeks. As LLLT is painless and athermal, participants are unlikely to distinguish the sham condition. Standard safety protocols will be maintained.",[16],[35,36],"Sham Laser auriculotherapy","Sham Auricular Photobiomodulation Therapy",{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Myofascial release","Myofascial release is a manual therapy applied bilaterally to the masseter and temporalis muscles as a baseline intervention. Each session includes 1 minute of ischemic pressure, 1 minute of myofascial release, 30 seconds of positional release, and 30 seconds of general mobilization per muscle. The protocol consists of two sessions per week for three weeks (six sessions total), aiming to reduce muscle tension and improve mandibular function.",[9,16],null,[43],{"name":44,"affiliation":45,"role":46},"Hernán A de la Barra, PhD.","Exercise and Rehabilitation Sciences Institute, School of Physical Therapy, Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago 7591538, Chile","PRINCIPAL_INVESTIGATOR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","984706322","56","hdelabarra@unab.cl",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Claudio Chamorro, PhD.","99439 8014","handresdelabarra@yahoo.es",[58],{"facility":59,"status":41,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":41},"Universidad Andrés Bello","Santiago","Santiago Metropolitan","7591538","Chile","CL",{"type":66,"coordinates":67},"Point",[68,69],-70.64827,-33.45694,{"lat":69,"lon":68},{"type":46,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Hernán Andrés de la Barra Ortiz","PhD.","100602583","low-level-laser-auriculotherapy-in-the-treatment-of-myogenic-temporomandibular-disorders-and-anxiety-100602583",false,"NCT07125404","Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety","Effectiveness of Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of unilateral or bilateral myogenic temporomandibular disorder (TMD) based on DC\u002FTMD criteria.\n* Presence of myalgia or myofascial pain in the masticatory muscles, either spontaneous or induced by clinical palpation.\n* At least one episode of local, referred, or radiating masticatory pain in the past 30 days, lasting at least one hour.\n* Score ≥ 5 on the Generalized Anxiety Disorder 7-item scale (GAD-7), indicating generalized anxiety.\n\nExclusion Criteria:\n\n* Recent musculoskeletal injury in the cervical region.\n* Skin lesions or dermatological conditions on the auricle.\n* Regular use of medications such as corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or photosensitizing agents (e.g., tetracyclines, quinolones, sulfonamides).\n* Tattoos on or near the auricular area.\n* History of cancer or tumors within the past five years.\n* Fitzpatrick skin phototype V or VI.\n* Autoimmune diseases (e.g., lupus erythematosus, hepatic porphyria, pellagra).\n* Epilepsy.\n\nDiscontinuation Criteria\n\n\\- The participant's withdrawal or non-attendance results in the failure to complete the evaluation or treatment protocol.","ALL","18 Years",{"count":84,"type":85},32,"ESTIMATED","INTERVENTIONAL",[88],"NA","Summary:\n\nLow-level laser auriculotherapy (LLLT-AT) is a non-invasive technique that has gained attention for managing musculoskeletal pain and anxiety. Given the painful and emotional components of temporomandibular disorders (TMD), LLLT-AT may offer therapeutic benefits by stimulating auricular points associated with pain modulation and anxiety reduction. This randomized, placebo-controlled, two-arm clinical trial with blinded outcome assessors aims to evaluate the effects of LLLT-AT in individuals diagnosed with myogenic TMD (Axis I, Group I of the DC\u002FTMD classification) and anxiety. The study will be conducted at the Physical Agents Laboratory of Universidad Andrés Bello. Eligible participants will include members of the university community with myogenic TMD (Axis I, Group I of the DC\u002FTMD classification) and anxiety. Participants will be stratified by sex and randomly assigned to either an experimental group receiving LLLT-AT combined with a standardized myofascial release protocol or a control group receiving sham LLLT-AT with the same myofascial protocol. Interventions will be administered twice weekly for three weeks. Outcome measures will be collected at baseline, post-intervention, and at a four-week follow-up. Primary outcomes include pressure pain threshold (PPT), assessed by algometry, and anxiety level, measured using the GAD-7 scale. Secondary outcomes include maximum mouth opening range of motion (MMOROM) and mandibular functional limitation (MFL), assessed using the Jaw Functional Limitation Scale 8 (JFLS-8).",[91,92],"Temporomandibular Disorder","Anxiety State",[94,95,96,97,98,99],"Laser Therapy","Low-level Light Therapy","Auriculotherapy","Joint Disorders","Temporomandibular Joint Dysfunction Syndrome","Anxiety","NOT_YET_RECRUITING","2025-08-12",{"date":103,"type":104},"2025-08-15","ACTUAL",{"date":106,"type":85},"2025-09-01",{"date":108,"type":85},"2026-05-01",{"name":5,"class":6},1]