Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelength (810 + 980 NM) in Children and Adolescents With Facial Muscle Pain and Headache: Protocol for a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain intensity based on Faces Pain Scale
研究概览
简要总结
This randomized clinical trial evaluates the effects of photobiomodulation with a superpulsed diode laser (810 + 980 nm) on orofacial pain and tension-type headache in children and adolescents. Sixty participants will be assigned to receive active PBM or sham therapy over eight sessions. Pain and anthropometric variables will be assessed.
详细描述
Orofacial pain and tension-type headache are common in children and adolescents, often impairing school performance, social interactions, and functional development. Due to potential side effects of pharmacological treatments, non-pharmacological alternatives like photobiomodulation (PBM) are being studied. This protocol evaluates the effects of PBM with a superpulsed dual-wavelength diode laser (810 nm + 980 nm) applied to masseter and temporal muscles across eight sessions. Sixty participants (aged 6-17) will be randomized into two groups: G1 (active PBM) and G2 (sham). Anthropometric data (age, weight, height, BMI, Fitzpatrick phototype), penetrated energy, and local temperature will be recorded. Pain will be assessed using the Faces Pain Scale and the ICHD-3 questionnaire. The primary outcome is pain reduction. Secondary outcomes include correlations between anthropometric factors, energy penetration, and clinical response. A linear mixed model with repeated measures will be used for statistical analysis.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents 6 to 17 years of age enrolled at the medical and dental clinic of Universidade Nove de Julho (UNINOVE), Vergueiro Campus;
- •Children and adolescents who present with at least one symptom of orofacial pain and/or headache, according to the Faces Pain Scale and the childhood and adolescence headache questionnaire based on the ICHD-3
排除标准
- •Pregnant adolescents;
- •Having taken corticoids, non-steroidal anti-inflammatory drugs or analgesics in the previous 30 days;
- •Having taken isotretinoin;
- •Individuals who report photosensitivity to laser or LED in previous treatments.
研究组 & 干预措施
Group 1 - Local photobiomodulation
Participants in this arm will receive local photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual wavelengths (810 nm and 980 nm). The protocol consists of 8 sessions (twice weekly for 4 weeks), with laser applied to the masseter, temporal, trapezius, and temporomandibular joint (TMJ) regions. Each point will be irradiated for 13 seconds using 4 J of energy (10.52 J/cm²) with a contact technique. Safety procedures include use of protective eyewear and disinfection of the device tip.
干预措施: Active Photobiomodulation (Device)
Group 2 - Sham local photobiomodulation
Participants in this arm will undergo the same treatment protocol as the experimental group. However, the device will be deactivated (no laser emission), while maintaining the guide light and operational sounds to ensure participant blinding. All application parameters and session conditions will mimic the active group.
干预措施: Sham Photobiomodulation (Device)
结局指标
主要结局
Pain intensity based on Faces Pain Scale
时间窗: Weekly, up to 4 weeks
The Faces Pain Scale will be completed weekly by the legal guardians during the second therapeutic session of each treatment week.
Headache classification using ICHD-3
时间窗: Weekly, up to 4 weeks
The ICHD-3 questionnaire will be completed weekly by the legal guardians during the second therapeutic session of each treatment week.
次要结局
- Light transmission(Day 1)
- Local temperature(Day 1)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho