Neuromodulatory Effects of Low-Level Laser Therapy (LLLT) in Temporomandibular Joint (TMJ) Disorders: A Functional MRI study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Clinical assessments of
研究概览
简要总结
Objectives
To evaluate changes in neural activity in key pain-related brain regions (e.g., anterior cingulate cortex, insula, prefrontal cortex) following LLLT treatment.
To assess the impact of LLLT on functional connectivity within pain-processing networks, including the default mode network and salience network.
To correlate neural changes with clinical pain scores and functional improvement in TMJ disorders.
Study Design:
A prospective, longitudinal study with a pre-treatment and post-treatment assessment.
Participants:
15 patients diagnosed with TMJ disorders based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
15 age- and gender-matched healthy controls for baseline comparisons.
Intervention:
LLLT will be applied to TMJ-affected areas using a laser device (e.g., 810 nm wavelength, 6J/cm² energy density) in 2 times per week for four weeks.
Data Collection:
Clinical Assessments:
Pain intensity using the Visual Analog Scale (VAS).
Jaw functional limitation using the Jaw Functional Limitation Scale (JFLS).
Neuroimaging Assessments:
fMRI scans pre- and post-LLLT treatment.
esting-state fMRI to evaluate functional connectivity in pain-related networks.
Task-based fMRI during nociceptive stimulation to assess regional brain activation.
Data Analysis:
Voxel-wise comparison of task-based fMRI activation maps before and after LLLT.
Correlation analysis between changes in neural activity/connectivity and clinical outcomes.
Expected Outcomes
LLLT will reduce pain-related activation in the anterior cingulate cortex, insula, and prefrontal cortex.
LLLT will enhance functional connectivity in pain-modulating networks.
The observed neural changes will correlate with reductions in pain intensity and improved jaw function, providing evidence of central mechanisms underlying LLLT’s efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients clinically diagnosed with TMD as per the latest version of RDC or TMD.
- •2.Patients willing to participate who have given consent for the study.
- •Patients with blood parameters (CBC, RA Factor and Uric Acid) levels within normal limits.
排除标准
- •1.Subjects with history of orthodontic or prosthodontic treatment.
- •2.Subjects with history of trauma or surgery of the TMJ.
- •3.Subjects with history of previous treatment for the same complaint.
- •Subjects with OPG showing degenerative changes in the mandibular condyle e.g. rheumatoid arthritis, osteoarthritis.
结局指标
主要结局
Clinical assessments of
时间窗: Baseline, 4 week
Pain intensity using the Visual Analog Scale and
时间窗: Baseline, 4 week
Jaw functional limitation using the Jaw Functional Limitation Scale will be done preoperatively by a trained observer.
时间窗: Baseline, 4 week
次要结局
- 1.To evaluate changes in neural activity in key pain-related brain regions (e.g., anterior cingulate cortex, insula, prefrontal cortex) following LLLT treatment in TMD patients.(2.To assess the impact of LLLT on functional connectivity within pain-processing networks, including the default mode network and salience network.)
研究者
Harshita Tiwari
Institute of medical sciences