Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 9:28 PM
Study NCT ID:
NCT07125404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D013706', 'term': 'Temporomandibular Joint Dysfunction Syndrome'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089803', 'term': 'Myofascial Release Therapy'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel-group, randomized, placebo-controlled trial with participant and assessor blinding'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain pressure thereshold (PPT)', 'timeFrame': 'Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)', 'description': 'PPT will be assessed via algometry with the participant in a supine position. Four bilateral points on the masseter and temporalis muscles will be evaluated. Each point will be measured three times with 30-second intervals, and the average of each set will be calculated. The final PPT score will be the sum of the four-point averages, expressed in lb/cm². Data will be recorded in Microsoft Excel®.'}, {'measure': 'Anxiety level (AL)', 'timeFrame': 'Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)', 'description': 'AL will be assessed using the GAD-7 scale, a validated 7-item questionnaire scored from 0 to 3. It measures anxiety symptoms over the past month, with higher total scores indicating greater severity. The total score (0-21) will be calculated by summing all item responses. The GAD-7 is validated in Spanish and has demonstrated good sensitivity (0.83) and moderate specificity (0.46).'}], 'secondaryOutcomes': [{'measure': 'Maximum mandibular opening range of motion (MMOROM)', 'timeFrame': 'Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)', 'description': 'MMOROM will be measured with the participant in a supine position, head in neutral alignment. The distance between the incisal edges of the upper and lower central incisors during maximum mouth opening will be recorded using a millimeter ruler.'}, {'measure': 'Mandibular functional limitation (MFL)', 'timeFrame': 'Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)', 'description': 'MFL will be assessed using the JFLS-8, an 8-item Likert-scale questionnaire measuring limitations in jaw function, including chewing, mouth opening, and verbal/non-verbal communication. Each item is scored from 0 (no limitation) to 10 (severe limitation). The total score will reflect the maximum reported limitation. The scale is validated in Spanish and has high reliability (ICC = 0.94-0.96) and strong correlation with the 20-item version (r = 0.86).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser Therapy', 'Low-level Light Therapy', 'Auriculotherapy', 'Joint Disorders', 'Temporomandibular Joint Dysfunction Syndrome', 'Anxiety'], 'conditions': ['Temporomandibular Disorder', 'Anxiety State']}, 'referencesModule': {'references': [{'pmid': '28068790', 'type': 'BACKGROUND', 'citation': 'List T, Jensen RH. Temporomandibular disorders: Old ideas and new concepts. Cephalalgia. 2017 Jun;37(7):692-704. doi: 10.1177/0333102416686302. Epub 2017 Jan 9.'}, {'pmid': '33889429', 'type': 'BACKGROUND', 'citation': 'Palmer J, Durham J. Temporomandibular disorders. BJA Educ. 2021 Feb;21(2):44-50. doi: 10.1016/j.bjae.2020.11.001. Epub 2020 Dec 24. No abstract available.'}, {'pmid': '38592227', 'type': 'BACKGROUND', 'citation': 'Zielinski G, Pajak-Zielinska B, Ginszt M. A Meta-Analysis of the Global Prevalence of Temporomandibular Disorders. J Clin Med. 2024 Feb 28;13(5):1365. doi: 10.3390/jcm13051365.'}, {'pmid': '37143640', 'type': 'BACKGROUND', 'citation': 'Alrizqi AH, Aleissa BM. Prevalence of Temporomandibular Disorders Between 2015-2021: A Literature Review. Cureus. 2023 Apr 2;15(4):e37028. doi: 10.7759/cureus.37028. eCollection 2023 Apr.'}, {'pmid': '38873743', 'type': 'BACKGROUND', 'citation': 'Yap AU, Lai YC, Ho HCW. Prevalence of temporomandibular disorders and their associated factors in Confucian heritage cultures: A systematic review and meta-analysis. J Oral Rehabil. 2024 Oct;51(10):2169-2194. doi: 10.1111/joor.13779. Epub 2024 Jun 14.'}, {'pmid': '24482784', 'type': 'BACKGROUND', 'citation': 'Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. 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Healthcare (Basel). 2022 Sep 21;10(10):1816. doi: 10.3390/healthcare10101816.'}, {'pmid': '35274617', 'type': 'BACKGROUND', 'citation': 'Choi SY, Kim YJ, Kim B. [Effect of Auriculotherapy on Musculoskeletal Pain: A Systematic Review and Meta-Analysis]. J Korean Acad Nurs. 2022 Feb;52(1):4-23. doi: 10.4040/jkan.21121. Korean.'}, {'pmid': '35179436', 'type': 'BACKGROUND', 'citation': 'Lee EJ. Effects of auriculotherapy on addiction: a systematic review. J Addict Dis. 2022 Jul-Sep;40(3):415-427. doi: 10.1080/10550887.2021.2016011. Epub 2022 Feb 18.'}, {'pmid': '28145397', 'type': 'BACKGROUND', 'citation': 'Clijsen R, Brunner A, Barbero M, Clarys P, Taeymans J. Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2017 Aug;53(4):603-610. doi: 10.23736/S1973-9087.17.04432-X. Epub 2017 Jan 30.'}, {'pmid': '39112804', 'type': 'BACKGROUND', 'citation': 'de la Barra Ortiz HA, Arias M, Meyer von Schauensee M, Liebano RE. Efficacy of High-intensity laser therapy in patients with temporomandibular joint disorders: A systematic review and meta-analysis. Lasers Med Sci. 2024 Aug 7;39(1):210. doi: 10.1007/s10103-024-04162-4.'}, {'pmid': '26858986', 'type': 'BACKGROUND', 'citation': 'Cotler HB, Chow RT, Hamblin MR, Carroll J. The Use of Low Level Laser Therapy (LLLT) For Musculoskeletal Pain. MOJ Orthop Rheumatol. 2015;2(5):00068. doi: 10.15406/mojor.2015.02.00068. Epub 2015 Jun 9.'}, {'type': 'BACKGROUND', 'citation': 'Marques SL, Ramos AC da S, Boggiss ÉA, de Lima RA, Pinheiro-Araújo CF, Santos ATS, et al. The effect of photobiomodulation auriculotherapy in the treatment of temporomandibular disorders: A double-blind randomized feasibility study. J Photochem Photobiol. 2023 Dec 1;18:100210.'}, {'pmid': '29920521', 'type': 'BACKGROUND', 'citation': 'Sampaio-Filho H, Bussadori SK, Goncalves MLL, da Silva DFT, Borsatto MC, Tortamano IP, Longo PL, Pavani C, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT. Low-level laser treatment applied at auriculotherapy points to reduce postoperative pain in third molar surgery: A randomized, controlled, single-blinded study. PLoS One. 2018 Jun 19;13(6):e0197989. doi: 10.1371/journal.pone.0197989. eCollection 2018.'}, {'pmid': '35405631', 'type': 'BACKGROUND', 'citation': 'Menezes FDS, Chaves ECL, Mantuani APA, Marino LS, Alcantara MAR, Nassif MS, de Castro Moura C, Carvalho LC, Iunes DH. Effects of low-power laser auriculotherapy on chronic spinal pain: Randomized clinical trial. Complement Ther Clin Pract. 2022 Aug;48:101578. doi: 10.1016/j.ctcp.2022.101578. 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Epub 2019 Jun 17.'}, {'pmid': '33280944', 'type': 'BACKGROUND', 'citation': 'Fisch G, Finke A, Ragonese J, Dugas L, Wrzosek M. Outcomes of physical therapy in patients with temporomandibular disorder: a retrospective review. Br J Oral Maxillofac Surg. 2021 Feb;59(2):145-150. doi: 10.1016/j.bjoms.2020.08.068. Epub 2020 Aug 20.'}, {'pmid': '34501273', 'type': 'BACKGROUND', 'citation': 'Aguiar ADS, Nogueira Carrer HC, de Lira MR, Martins Silva GZ, Chaves TC. Patient-Reported Outcome Measurements in Temporomandibular Disorders and Headaches: Summary of Measurement Properties and Applicability. J Clin Med. 2021 Aug 26;10(17):3823. doi: 10.3390/jcm10173823.'}, {'pmid': '18780535', 'type': 'BACKGROUND', 'citation': 'Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. 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Validation of the generalized anxiety disorder scales (GAD-7 and GAD-2) in primary care settings in Latvia. Front Psychiatry. 2022 Oct 6;13:972628. doi: 10.3389/fpsyt.2022.972628. eCollection 2022.'}, {'pmid': '39791447', 'type': 'BACKGROUND', 'citation': 'Sun R, Liu T, Liu Y, Zhang S, Yue Y, Jiang N, Zhang L, Xiong X. Simplified Jaw Functional Limitation Scale for Temporomandibular Disorders: Psychometric Evaluation. Oral Dis. 2025 Jun;31(6):1854-1860. doi: 10.1111/odi.15253. Epub 2025 Jan 10.'}]}, 'descriptionModule': {'briefSummary': '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/TMD 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/TMD 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).', 'detailedDescription': "Material and Methods\n\n1. Study design:\n\n A double-blind, randomized, placebo-controlled trial with two parallel groups.\n2. Study population:\n\n Participants will include students, faculty, and administrative staff from Universidad Andrés Bello, Casona de Las Condes Campus. Recruitment will be conducted through institutional channels such as bulletin boards, digital posters, and official emails. Interested individuals will be invited for an in-person screening at the Physical Agents Laboratory (KIN 401, Building C5) of the School of Rehabilitation Sciences. The screening will involve a study explanation, eligibility assessment, and a physical examination conducted by an experienced physiotherapist to confirm a myogenic temporomandibular disorder (Axis I, Group I, DC/TMD classification).\n3. Sample size and randomization:\n\n Sample size will be calculated using G\\*Power® software, assuming a statistical power of 80% (1-β), a significance level of 0.05 (α), a 95% confidence level, and an estimated effect size of 1.0. This value is based on the study by Sancakli et al. (see reference), who reported an increase in the pressure pain threshold (PPT) of the masseter muscle in patients with myogenic temporomandibular disorders following four weeks of treatment with low-level laser therapy (LLLT). The minimum estimated sample size is 28 participants, 14 per group (LLLT-AT plus myofascial release and sham LLLT-AT plus myofascial release). To account for potential data loss or participant dropout during the study, researchers will apply a 15% increase to the calculated sample size. This decision aligns with item 8 of the Physiotherapy Evidence Database (PEDro) scale, which requires that outcome measures be obtained from at least 85% of participants. Therefore, a minimum of 16 participants per group will be recruited.\n\n Selected participants will be allocated into two groups through a simple randomization process: experimental group (LLLT-AT) and control group (sham LLLT-AT). Additionally, stratification by sex will be performed to ensure an equal proportion of male and female participants in each group. Randomization will be carried out using the web-based tool Research Randomizer (https://www.randomizer.org/). FFollowing the laser intervention, both the experimental and control groups will receive bilateral myofascial release treatment targeting the masticatory muscles (masseter and temporalis) (35). Participants will be blinded to group allocation.\n4. Selection criteria\n\n * Inclusion Criteria: Participants must be ≥18 years old, of any gender, with a clinical diagnosis of unilateral or bilateral myogenic temporomandibular disorder (TMD) based on DC/TMD criteria. This includes spontaneous or palpation-induced myalgia in the masticatory muscles. Participants must have experienced at least one episode of local, referred, or radiating masticatory pain in the past 30 days lasting at least one hour. A GAD-7 score of ≥5 is also required.\n * Exclusion Criteria: Recent musculoskeletal injuries in the cervical region; skin lesions or diseases on the auricle; regular use of medications such as corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or photosensitizing agents (e.g., tetracyclines, quinolones, or sulfonamides); tattoos on or near the auricular region; history of cancer or tumors within the past five years; Fitzpatrick skin phototypes V-VI; autoimmune diseases (e.g., lupus erythematosus, hepatic porphyria, or pellagra); and epilepsy.\n * Discontinuation Criteria: Participants who fail to complete the evaluation or treatment protocol due to withdrawal or non-attendance will be excluded from the final analysis.\n5. Interventions:\n\n The experimental group will receive two weekly sessions of low-level laser auriculotherapy (LLLT-AT), while the control group will receive two weekly sessions of sham LLLT-AT. Sessions will be scheduled with a two-day interval between each session. Both groups will receive a standard manual therapy protocol consisting of bilateral myofascial release of the masseter and temporalis muscles. A total of six treatment sessions will be administered over three weeks.\n * LLLT-AT Procedure. The experimental group will be treated with low-level laser auriculotherapy using an infrared low-power diode laser (class IIIb) with a wavelength of 905 nm. LLLT-AT will be applied to four auricular acupuncture points: Shenmen (TF4), Kidney (AH9), Liver (AH11), and Point Zero (O'). The protocol proposed by Marques et al. (2023) will be followed, delivering 4 joules (J) of energy per point. Treatment parameters include a mean output power of 71 milliwatts (mW) and an irradiation time of 56 seconds per point (total application time: 224 seconds), resulting in a total energy dose of 16 J per session. LLLT-AT will be applied to the auricle ipsilateral to the symptomatic temporomandibular joint (TMJ). In cases of bilateral pain, the side with the greater self-reported pain will be treated. Sessions will be performed with the participant in the lateral decubitus position, exposing the treated ear. Both the participant and the therapist will wear protective laser goggles during the procedure. The laser device used will be the Combi 400L by GYMNA®.\n * Sham LLLT-AT. In the sham laser group, participants will be treated under the same conditions as the experimental group, using the same equipment (Gymna® COMBI 400L laser), identical dosing parameters, and the same procedural precautions. However, a simulated laser emission will be applied by disconnecting the laser probe, thus preventing beam delivery. This condition will be difficult for participants to detect, as LLLT is an athermal intervention and does not produce perceptible sensations during application.\n * Myofascial Release. Both groups will receive a standard manual therapy intervention based on bilateral myofascial release techniques applied to the masticatory muscles (masseter and temporalis) following this protocol: (A) Temporalis muscle relaxation: Ischemic compression of the trigger point (1 minute), myofascial release of the trigger point (1 minute), positional release (30 seconds), and global myofascial release of the temporalis muscle (30 seconds); (B) Masseter muscle relaxation: Ischemic compression of the trigger point (1 minute), myofascial release of the trigger point (1 minute), positional release (30 seconds), and global myofascial release of the masseter muscle (30 seconds).\n6. Outcome Measures:\n\n Primary outcomes will include changes in pressure pain threshold (PPT) and anxiety level (AL). Secondary outcomes will include changes in maximum mandibular opening range of motion (MMOROM) and mandibular functional limitation (MFL). All assessments will be performed by a blinded independent evaluator. PPT will be measured using algometry at two bilateral points associated with the masseter and temporalis muscles. AL, MMOROM, and MFL will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7), a millimeter ruler, and the 8-item Jaw Functional Limitation Scale (JFLS-8), respectively. Assessments will be conducted at three time points: baseline (T0), post-treatment (T1: after the 6th LLLT-AT session, end of week 3), and follow-up (T2: 4 weeks after the end of treatment).\n * PPT. PPT will be measured using a WAGNER FPX® pressure algometer. Assessments will be performed with the participant in a supine position. Four bilateral muscle sites (masseter and temporalis) will be evaluated. Each site will be measured three times with 30-second intervals; the average will be calculated per site. The total PPT will be the sum of the four site averages, expressed in lb/cm². To assess intra-rater reliability, the intraclass correlation coefficient (ICC) will be calculated using repeated PPT measurements at the upper trapezius midpoint in 13 healthy volunteers, with a 48-hour interval.\n * AL. Anxiety will be assessed using the GAD-7 scale, a 7-item Likert questionnaire scored 0-3 per item (Appendix 5). The total score (range: 0-21) reflects anxiety severity. The GAD-7 has been validated in Spanish, with sensitivity = 0.83 and specificity = 0.46 (30,43).\n * MMOROM.The measurement was conducted in the supine position using a millimeter ruler. Researchers will record the distance between the upper and lower central incisors at maximum mouth opening.\n * MFL. The Jaw Functional Limitation Scale (JFLS-8), an 8-item Likert scale (0-10 per item) covering chewing, mouth opening, and communication tasks, will be used to assess the MFL. The maximum score will be used. The JFLS-8 is validated in Spanish and has high reliability (ICC = 0.94-0.96) with a strong correlation to the 20-item version (r = 0.86).\n7. Variables\n\n Conceptual Definition of Study Variables:\n * PPT. The amount of pressure applied to the bellies of the masticatory muscles (masseter and temporalis) that the participant perceives as painful.\n * AL. The degree of tension and/or worry reported by the participant in the past two weeks, framed within the definition of generalized anxiety disorder.\n * MMOROM. The extent or range of movement demonstrated by the participant during maximal mouth opening.\n * MFL. The restriction in the ability of the jaw to perform daily activities such as speaking, smiling, eating, or other functions.\n * LLLT-AT. A therapeutic intervention involves applying laser light with a power below 0.5 watts (W) to specific points on the auricle, which are associated with pain and anxiety modulation.\n * Myofascial Release: A bilateral manual therapy intervention applied to the masticatory muscles (masseter and temporalis).\n\n Operational Definition of Study Variables:\n * PPT. The PPT will be measured using pressure algometry with a WAGNER FPX algometer. PPT values will be recorded in pounds per square centimeter (lb/cm²).\n * AL. The GAD-7 will be used for assessment. This Likert-scale instrument consists of 7 items scored from 0 to 3. Higher scores indicate greater anxiety severity. The total score classifies anxiety into four categories: no anxiety (0-4), mild (5-9), moderate (10-14), and severe (15-21).\n * MMOROM. The measurement will be done in millimeters using a 10-cm ruler. The evaluator will record the distance between the incisal edges of the upper and lower central incisors during maximal mouth opening.\n * MFL. The JFLS-8 is used to measure MFL. Each item is rated on a 0-10 Likert scale; higher scores indicate greater functional limitation.\n * LLLT-AT. The treatment will be administered using an infrared laser with a wavelength of 905 nm and a power output of 71 mW, which delivers 4 joules (J) of energy per point. The device used will be the Combi 400L (GYMNA®).\n * Myofascial Release: A bilateral treatment will be applied to the masseter and temporalis muscles, consisting of the following sequence: trigger point pressure (1 min), trigger point myofascial release (1 min), positional release (30 sec), and general muscle myofascial release (30 sec).\n\n Study Variable Type\n * PPT. Dependent variable; continuous quantitative.\n * AL. Dependent variable; ordinal qualitative.\n * MMOROM. Dependent variable; continuous quantitative.\n * MFL. Dependent variable; ordinal qualitative.\n * LLLT-AT. Independent variable; continuous quantitative.\n * Myofascial Release: Independent variable; nominal qualitative.\n8. Study phases\n\n The study will be conducted in three phases:\n\n \\- Phase 1 - Screening (2 weeks): A digital screening questionnaire will be distributed to the target population to identify potentially eligible participants. Responses will be reviewed to assess initial eligibility based on inclusion criteria. Individuals who meet the criteria will be contacted and invited to participate. Written informed consent will be obtained prior to enrollment.\n\n \\- Phase 2 - Baseline Assessment (2 weeks): Participants will undergo a standardized physical examination to confirm the presence of myogenic TMD, based on the DC/TMD diagnostic criteria. A trained physiotherapist will perform bilateral palpation of the masseter and temporalis muscles. Those presenting localized or referred pain during palpation will be considered eligible. Participants with positive findings will complete the GAD-7 questionnaire to assess anxiety levels.\n\n \\- Phase 3 - Intervention and Follow-up (3 weeks + 4-week follow-up): Eligible participants will be randomly assigned to one of two groups: (1) an experimental group receiving LLLT-AT and (2) a control group receiving sham LLLT-AT. Both groups will also receive standardized bilateral myofascial release of the masseter and temporalis muscles. Treatment will be delivered twice per week for three weeks. Primary and secondary outcomes-including PPT, AL, MMOROM, and MFL-will be assessed at baseline, after the intervention, and at 4-week follow-up. All evaluations will be conducted by a blinded assessor, and data will be recorded and managed using Microsoft Excel®.\n9. Statistical Analysis Descriptive statistics will be presented for demographic and outcome variables-PPT, AL, MMOROM, and MFL-using measures of central tendency and dispersion: means with standard deviations (mean ± SD) or medians with interquartile ranges (median, IQR), depending on data distribution. Normality will be assessed using the Shapiro-Wilk test. A summary table of participant demographic characteristics will be created and stratified by group. For secondary variables such as sex and body mass index, frequencies and either means or medians will be reported, as appropriate.\n\nFor inferential analysis, parametric or non-parametric tests will be selected based on the normality assessment. If normal distribution is confirmed, a two-way ANOVA (factors: group and time) will be applied. If data are non-normally distributed, the Kruskal-Wallis test will be used. Post-hoc analyses will be conducted using Bonferroni or Tukey corrections, as appropriate to the primary test used.\n\nAll analyses will be performed using IBM SPSS Statistics version 26, with the significance level set at p \\< 0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of unilateral or bilateral myogenic temporomandibular disorder (TMD) based on DC/TMD 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."}, 'identificationModule': {'nctId': 'NCT07125404', 'briefTitle': 'Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Quiropraxia y Equilibrio'}, 'officialTitle': 'Effectiveness of Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '06082025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LLLT-AT', 'description': "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.", 'interventionNames': ['Radiation: Low-level laser auriculotherapy (LLLT-AT)', 'Other: Myofascial release']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham LLLT-AT', 'description': '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.', 'interventionNames': ['Other: Sham Low-level laser auriculotherapy (sham LLLT-AT)', 'Other: Myofascial release']}], 'interventions': [{'name': 'Low-level laser auriculotherapy (LLLT-AT)', 'type': 'RADIATION', 'otherNames': ['Laser Auriculotherapy', 'Auricular Photobiomodulation Therapy'], 'description': '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.', 'armGroupLabels': ['LLLT-AT']}, {'name': 'Sham Low-level laser auriculotherapy (sham LLLT-AT)', 'type': 'OTHER', 'otherNames': ['Sham Laser auriculotherapy', 'Sham Auricular Photobiomodulation Therapy'], 'description': '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.', 'armGroupLabels': ['Sham LLLT-AT']}, {'name': 'Myofascial release', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['LLLT-AT', 'Sham LLLT-AT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7591538', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Universidad Andrés Bello', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Hernán A de la Barra, PhD.', 'role': 'CONTACT', 'email': 'hdelabarra@unab.cl', 'phone': '984706322', 'phoneExt': '56'}, {'name': 'Claudio Chamorro, PhD.', 'role': 'CONTACT', 'email': 'handresdelabarra@yahoo.es', 'phone': '99439 8014', 'phoneExt': '56'}], 'overallOfficials': [{'name': 'Hernán A de la Barra, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Exercise and Rehabilitation Sciences Institute, School of Physical Therapy, Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago 7591538, Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quiropraxia y Equilibrio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD.', 'investigatorFullName': 'Hernán Andrés de la Barra Ortiz', 'investigatorAffiliation': 'Quiropraxia y Equilibrio'}}}}