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

ConditionsTemporomandibular DisorderAnxiety State
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuiropraxia y Equilibrio

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

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

    Other intervention

    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.

  • Myofascial release

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: LLLT-ATExperimental treatment 2 interventions
Group B: Sham LLLT-ATSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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®.

Time frame
Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)
2

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).

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

Secondary outcomes

1

Maximum mandibular opening range of motion (MMOROM)

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.

Time frame
Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)
2

Mandibular functional limitation (MFL)

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Quiropraxia y Equilibrio

Lead sponsor

Source ClinicalTrials.gov

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