Photobiomodulation in the Management of Myofascial Pain: A Randomized and Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Assessment of Myofascial Pain Intensity
研究概览
简要总结
This randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Participants will be allocated into three groups: PBM alone, PBM combined with exercises, or placebo PBM combined with exercises. The intervention consists of 12 treatment sessions. Outcomes related to pain intensity, mandibular function, and clinical measures will be assessed over time. The study seeks to investigate whether PBM provides additional benefits in pain reduction and functional improvement in individuals with myofascial TMD.
详细描述
This randomized, assessor-blinded, parallel-group clinical trial aims to evaluate the effects of photobiomodulation therapy (PBM) on clinical and psychosocial outcomes in adults with myofascial temporomandibular disorders (TMD). Myofascial pain is one of the most prevalent subtypes of TMD and is frequently associated with muscle tenderness, functional limitation, chronic pain, and psychological distress. Conservative and non-invasive therapies are considered first-line approaches, and PBM has emerged as a promising modality due to its potential anti-inflammatory and analgesic effects.
The primary objective of this study is to analyze the impact of PBM on muscle pain intensity, assessed using the Visual Analog Scale (VAS). Secondary objectives include evaluating specific muscle pain through DC/TMD clinical examination, chronic pain severity using the Graded Chronic Pain Scale version 2 (GCS v2), mandibular functional limitation using the Jaw Functional Limitation Scale (JFLS-20), quality of life assessed using the Patient Health Questionnaire (PHQ-9), and anxiety symptoms using the Generalized Anxiety Disorder scale (GAD-7).
A total of 120 adult undergraduate and graduate students from the Federal University of Rio Grande do Sul (UFRGS) will be recruited through institutional dissemination and interest forms. Eligible participants must be 18 years or older, diagnosed with myofascial TMD according to DC/TMD criteria, and able to attend all treatment sessions and follow-up assessments. Individuals with systemic musculoskeletal conditions, recent head and neck malignancy, previous temporomandibular joint surgery, pregnancy or lactation, severe psychiatric conditions that prevent participation, or ongoing treatments that may interfere with outcomes will be excluded.
Participants will undergo baseline assessment and will be randomly allocated (1:1:1) into three groups: (1) PBM alone; (2) PBM combined with therapeutic exercises; or (3) placebo PBM combined with therapeutic exercises. PBM will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally at standardized anatomical points over the temporomandibular joint and masticatory muscles. The intervention will consist of 12 treatment sessions performed three times per week over four weeks. Participants allocated to the exercise groups will perform daily home-based therapeutic exercises focused on muscle relaxation, joint mobility, and functional improvement, with adherence monitoring throughout the study.
Randomization will be performed by an independent investigator using a centralized allocation system with concealment procedures. Participants will remain blinded regarding active or placebo laser application, and outcome assessors and statisticians will remain blinded to group allocation to minimize performance and detection bias. Due to the nature of the interventions, the therapist delivering PBM will not be blinded.
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
- •Individuals with myofascial TMD (ICD-9 729.1; ICD-10 M79.1) diagnosed according to the DC/TMD criteria;
- •Participants aged 18 years or older;
- •Individuals able to communicate, read, write, and provide written informed consent in Portuguese.
排除标准
- •Patients with a history of autoimmune connective tissue diseases, such as rheumatoid arthritis, psoriatic arthritis, scleroderma, or systemic lupus erythematosus;
- •History of malignancy in the head and neck region within the past 2 years (except basal cell carcinoma) who have undergone head and neck radiation therapy and/or surgery affecting facial muscles;
- •Patients who have undergone temporomandibular joint surgery or orthognathic surgery;
- •Pregnant or breastfeeding women;
- •Patients with poorly adapted prostheses and/or prostheses associated with inadequate increase or decrease of the vertical dimension;
- •Patients with a history of tardive dyskinesia or oromandibular/cervical dystonia; -Patients with maximum mouth opening less than 35 mm;
- •Patients using systemic medications with a potential effect on pain at the time of screening will not be included in the study, including analgesics, anti-inflammatory drugs, muscle relaxants, corticosteroids, or other medications with analgesic and/or anti-inflammatory effects.
- •If a participant initiates the use of any such medication during the follow-up period, the participant will be excluded from the study.
- •- Patients receiving oral and/or intravenous corticosteroid bolus therapy at doses > 1 mg/kg within the past 3 months, and those receiving biologic agents within 1 month or five times the drug half-life, whichever is longer; Individuals with mental or psychological conditions that may prevent participation in the study.
研究组 & 干预措施
Photobiomodulation Therapy
Participants assigned to this arm will receive photobiomodulation therapy using a dual-wavelength diode laser (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention consists of 12 treatment sessions conducted over four weeks.
干预措施: Photobiomodulation Therapy (Device)
Photobiomodulation Therapy + Exercises
Participants assigned to this arm will receive extraoral photobiomodulation therapy (PBM) using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), delivering 20 J per application point over standardized anatomical points of the temporomandibular joint and masticatory muscles (six points per side). The intervention consists of 12 treatment sessions conducted over four weeks.
Additionally, participants will perform a standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided.
干预措施: Photobiomodulation Therapy (Device)
Photobiomodulation Therapy + Exercises
Participants assigned to this arm will receive extraoral photobiomodulation therapy (PBM) using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), delivering 20 J per application point over standardized anatomical points of the temporomandibular joint and masticatory muscles (six points per side). The intervention consists of 12 treatment sessions conducted over four weeks.
Additionally, participants will perform a standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided.
干预措施: Therapeutic Exercises (Behavioral)
Sham Photobiomodulation Therapy + Exercises
Participants assigned to this arm will receive sham extraoral photobiomodulation therapy using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), applied over standardized anatomical points of the temporomandibular joint and masticatory muscles with identical procedures to the active protocol, but without therapeutic energy emission to maintain participant blinding. The simulated intervention consists of 12 sessions conducted over four weeks.
Additionally, participants will perform the same standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided.
干预措施: Therapeutic Exercises (Behavioral)
Sham Photobiomodulation Therapy + Exercises
Participants assigned to this arm will receive sham extraoral photobiomodulation therapy using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), applied over standardized anatomical points of the temporomandibular joint and masticatory muscles with identical procedures to the active protocol, but without therapeutic energy emission to maintain participant blinding. The simulated intervention consists of 12 sessions conducted over four weeks.
Additionally, participants will perform the same standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided.
干预措施: Sham Photobiomodulation Therapy (Device)
结局指标
主要结局
Assessment of Myofascial Pain Intensity
时间窗: Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.
Myofascial pain intensity will be assessed using the Visual Analog Scale for Pain, ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable," with higher scores representing worse pain. Participants will rate (1) worst pain experienced in the previous 24 hours and (2) pain evoked by standardized clinical palpation. Palpation will be performed bilaterally on the masseter and temporalis muscles and on the temporomandibular joint region, using controlled and standardized pressure applied for approximately 2 seconds per palpation point by a trained examiner.
次要结局
- Muscle Pain(Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.)
- Chronic Pain(Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.)
- Mandibular Function(Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.)
- Depressive Symptoms(Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.)
- Anxiety Symptoms(Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.)
研究者
Manoela Domingues Martins
Associate Professor
Federal University of Rio Grande do Sul