Comparative Effectiveness of Low Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation on Pain and Mouth Opening in Temporomandibular Disorders Based Upon Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Pain Intensity (VAS Score)
研究概览
简要总结
Myofascial pain is the most common form of temporomandibular disorder (TMD) encountered in maxillofacial practice. Treatment options range from conservative management to open surgical procedures, with physical therapies identified as the safest and most effective. Among these, transcutaneous electrical nerve stimulation (TENS) is a widely used technique, while low-level laser therapy (LLLT) is a recent therapeutic advancement. This study is designed to compare the efficacy of these two therapies, aiming to identify the more effective option.
详细描述
A randomized clinical trial will be conducted at the Oral and Maxillofacial Surgery department, Punjab Dental Hospital, Lahore. Sample size of 40 patients will be selected through convenience sampling and divided into two equal groups, based on computergenerated random numbers. A written consent will be obtained from all the participants. Group A will receive LLLT, while Group B will receive TENS. The primary variables like pain score and mouth opening will be recorded preoperatively and during followup sessions. The proforma used for data collection will be designed, tailored to the needs of this study based on standard Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Both groups will receive their assigned therapies on alternate days for three weeks, with evaluations at 1st, 3rd, and 4th weeks post-treatment. All collected data will be entered into SPSS version 25 for statistical analysis. Independent sample t-test will be used to compare the mean pain score and mouth opening between the two groups. Repeated measures ANOVA will be applied to compare the primary variables in both groups on all follow-ups. P-value ≤0.05 will be considered as significant.
This study aims to offer tailored insights and practical recommendations, potentially improving patient care by providing safer and non-invasive alternatives to more invasive procedures thus enhancing overall treatment strategies. It is assumed that expected results shall be in favor of the LLLT group. Possible limitations may include failure of patients to come for multiple sessions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cases of myofascial pain in TMD patients, which fall under diagnostic criteria (DC/TMD).
- •Myofascial pain that persists for more than 3 months.
- •Involvement of trigger points in the masseter and temporalis muscles.
- •Impaired or limited mouth opening (less than 35mm).
排除标准
- •Congenital abnormality or neoplastic condition around TMJ.
- •Recent history of trauma affecting head and neck region.
- •Patients with known dermatological disorders (eczema, psoriasis).
- •Patients with pacemakers and cardiovascular diseases.
- •Epileptic patients.
- •Patients allergic to adhesive tapes or electrodes of TENS
结局指标
主要结局
Pain Intensity (VAS Score)
时间窗: 6 months
Change in pain intensity as measured by the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain) Unit of Measure: Centimeters (cm) Time Points: Pre-treatment, 1st week, 3rd week, and 4th week.
Mouth Opening (Active Interincisal Distance)
时间窗: 6 months
Change in active interincisal distance, measured using a ruler from the upper to lower incisal edges during maximum unassisted mouth opening. Unit of Measure: Millimeters (mm). Time Points: Pre-treatment, 1st week, 3rd week, and 4th week
次要结局
未报告次要终点
研究者
ARHUM BUTT
Postgraduate Resident
University of Health Sciences Lahore