Effectiveness of Low-Level Laser Auriculotherapy in the Treatment of Myogenic Temporomandibular Disorders and Anxiety: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Anxiety level (AL)
研究概览
简要总结
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).
详细描述
Material and Methods
- Study design:
A double-blind, randomized, placebo-controlled trial with two parallel groups. 2. Study population:
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). 3. Sample size and randomization:
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anxiety level (AL)
时间窗: Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)
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).
Pain pressure thereshold (PPT)
时间窗: Baseline, 3 weeks (6 sessions) and 4 weeks (follow-up)
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®.
次要结局
- 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))
研究者
Hernán Andrés de la Barra Ortiz
PhD.
Quiropraxia y Equilibrio