Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety

NCT07125404 | Not Yet Recruiting DMC

• 1 other identifier: 06082025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Low-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).

Conditions

Temporomandibular Disorder; Anxiety State

Keywords

Laser Therapy; Low-level Light Therapy; Auriculotherapy; Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Anxiety

Outcome Measures

Primary Outcomes (2)

• Pain pressure thereshold (PPT)

  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®.

  Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)

• Anxiety level (AL)

  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).

  Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)

Secondary Outcomes (2)

• Maximum mandibular opening range of motion (MMOROM)

  Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)

• Mandibular functional limitation (MFL)

  Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)

Study Arms (2)

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.

Radiation: Low-level laser auriculotherapy (LLLT-AT); Other: Myofascial release

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.

Other: Sham Low-level laser auriculotherapy (sham LLLT-AT); Other: Myofascial release

Interventions

Low-level laser auriculotherapy (LLLT-AT) RADIATION

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.

Also known as: Laser Auriculotherapy, Auricular Photobiomodulation Therapy

LLLT-AT

Sham Low-level laser auriculotherapy (sham LLLT-AT) OTHER

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.

Also known as: Sham Laser auriculotherapy, Sham Auricular Photobiomodulation Therapy

Sham LLLT-AT

Myofascial release OTHER

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.

LLLT-AT; Sham LLLT-AT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Clinical diagnosis of unilateral or bilateral myogenic temporomandibular disorder (TMD) based on DC/TMD criteria.
• Presence of myalgia or myofascial pain in the masticatory muscles, either spontaneous or induced by clinical palpation.
• At least one episode of local, referred, or radiating masticatory pain in the past 30 days, lasting at least one hour.
• Score ≥ 5 on the Generalized Anxiety Disorder 7-item scale (GAD-7), indicating generalized anxiety.

You may not qualify if:

• Recent musculoskeletal injury in the cervical region.
• Skin lesions or dermatological conditions on the auricle.
• Regular use of medications such as corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or photosensitizing agents (e.g., tetracyclines, quinolones, sulfonamides).
• Tattoos on or near the auricular area.
• History of cancer or tumors within the past five years.
• Fitzpatrick skin phototype V or VI.
• Autoimmune diseases (e.g., lupus erythematosus, hepatic porphyria, pellagra).
• Epilepsy.
• Discontinuation Criteria
• \- The participant's withdrawal or non-attendance results in the failure to complete the evaluation or treatment protocol.

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead

Study Sites (1)

Universidad Andrés Bello

Santiago, Santiago Metropolitan, 7591538, Chile

Location

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Anxiety Disorders; Joint Diseases; Temporomandibular Joint Dysfunction Syndrome

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Mental Disorders; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• 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

Central Study Contacts

Hernán A de la Barra, PhD.

CONTACT

984706322; hdelabarra@unab.cl

Claudio Chamorro, PhD.

CONTACT

99439 8014; handresdelabarra@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Model Details: Parallel-group, randomized, placebo-controlled trial with participant and assessor blinding

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 15, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)