Clinical, Psychosocial, Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of combining low-level laser therapy and the self-management program for patients with temporomandibular joint disorders using a randomized controlled design.
详细描述
The purpose of this study is to evaluate the efficacy of combining low level laser therapy and self-management program for patients with temporomandibular joint disorders using a randomized controlled design.
66 patients suffering from acute and subacute myalgia diagnosed using Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at High-tech Center for Odonto-Stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University, Viet Nam. Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups:
- Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise.
- Group 2: recieve low level laser treatment 3 times aweek, 20 seconds/ session, 10 sessions in total, combined with counseling, behavior modification, and exercise.
Assessment takes place at baseline, after treatment approximately 2 weeks, 4 weeks, 12 weeks, 24 weeks later and 48 weeks follow up. The effects of the interventions are evaluated in terms of reduction in pain intensity (Visual Analogue Scale-VAS), number of masticatory muscle pain point with palpation, number of supplemental muscle pain with palpation, maximum mouth opening, right lateral movements, left lateral movements, protrusive movements, Jaw functional limitation scale (JFLS-8), psychological variables such as PHQ-9, PHQ-4, GAD-7.
Data were entered and analyzed by SPSS 16.0 software. Use Mann-Whitney U test, Kruskal-Wallis test, and Wilcoxon test applied to non-normally distributed variables to compare VAS between groups at different follow-up times. Use paired t-test and independent t-test to compare the maximum opening, lateral movements, protrusive movements, JFLS-8, PHQ-9, PHQ-4, GAD-7 between groups before and after treatment. p value < 0.05 is considered statistically significant.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Temporomandibular joint Disorders (according to DC/TMD) with acute or subacute temporal muscle and/or masseter muscle pain (less than 3 months).
- •All patients aged 16 years or older, capable of comprehending the doctor's opinion and complying with the examination process.
排除标准
- •Patients with chronic TMDs pain, swelling and pain in the mouth that prevent wearing a occlusal splint.
- •Patients with history of severe neurological disorders, autoimmune joint and muscle diseases, advanced malignant cancer, history of mental illness, history of alcoholism, drug and painkiller abuse, undergoing surgery and/or radiotherapy on the neck and face, other treatments on the neck and temporomandibular joint within 3 months, use of drugs that may affect the neuromuscular system.
- •Pregnant patients
研究组 & 干预措施
Self-Management Program
Self-Management Program includes education about the disorder, proprioceptive awareness, and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.
干预措施: Self-Management Program (Behavioral)
Low level laser therapy combined with Self-Management Program
LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shone on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.
干预措施: Self-Management Program (Behavioral)
Low level laser therapy combined with Self-Management Program
LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shone on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.
干预措施: Low level laser therapy combined with Self-Management Program (Radiation)
Occlusal Splint combined with Self-Management Program
Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks. In addition, patients are still instructed Self-Management Program as group 1.
干预措施: Self-Management Program (Behavioral)
Occlusal Splint combined with Self-Management Program
Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks. In addition, patients are still instructed Self-Management Program as group 1.
干预措施: Occlusal Splint combined with Self-Management Program (Device)
结局指标
主要结局
VAS
时间窗: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
The VAS (Visual Analog Scale) pain scale consists of a 10 cm long straight line (without marks), with "no pain" written at the left end and "unbearable pain" written at the right end. Patients were instructed to mark a vertical line above the horizontal line indicating the intensity of their pain. The distance from the zero point to the marker is then measured in millimeters by a caliper. Add the total score of the answers to evaluate the severity according to the following scale: ≤3.4: mild; 3.5-7.4: average; ≥ 7.5: severe
Numbers of masticatory muscle pain with palpation
时间窗: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.
Maximum mouth opening
时间窗: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Maximum mouth opening (MMO) was defined asthe maximal interincisal distance on unassisted active mouth opening when the patient opens his mouth maximally without feeling pain. Use a ruler with mm value.
Numbers of supplemental muscle pain with palpation
时间窗: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of supplemental muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.
次要结局
- Right lateral movements(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
- Left lateral movements(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
- Protrusive movements(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
- JFLS-8(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
- GAD-7(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
- PHQ-9(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
- OBC(Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.)
研究者
Nguyen Ngoc Hoa
Lecturer
Hanoi Medical University