Comparative evaluation of effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and Low-Level Laser therapy (LLLT) in symptomatic Temporomandibular Disorders
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of TENS and LLLT in reducing TMD-related pain.
研究概览
简要总结
The study will be carried out on patients reporting to the Department of Oral Medicine and Radiology, Dr. R Ahmed Dental College & Hospital, Kolkata, clinically diagnosed with TMD associated with temporomandibular joint (TMJ) pain, clicking sound, pain in the muscles of mastication and with or without limited mouth opening.
Total 44 patients with the age range, 25–50 years, will be randomly selected from OPD, after obtaining informed consent. 44 patients will be randomly divided into two groups (group-A, group-B) of 22 each by an individual not participating in the study.
•Group-A will treated with TENS therapy for eight sessions (2 sessions per week), using a WBIDFC TENS 4 CH. device with 20 W power, 220 v voltage, and 50 Hz frequency, continuous mode for 10 minutes.
•Group-B will treated with LLLT for eight sessions (2 sessions per week), using a INDILASE diode laser in continuous wave mode with 810 nm wavelength, 0.2 W power, 10 sec time and 2 J/cm2 energy density.
The pain score (0-10, where 0 represents no pain and 10 represents the worst pain as perceived by the patient subjectively) will be evaluated before, during (mid-treatment), and after treatment using the visual analogue scale (VAS).
Inter-incisal mouth opening will be recorded before, during (mid-treatment), and after treatment using a vernier caliper. The present study is aimed to evaluate and compare the efficacy of TENS and LLLT, as an adjunct to medication in patients with TMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •History of TMD-related pain for the past 3 months Not taking any antidepressant medications Patients falling in Research Diagnostic Criteria for TMJ disorders (RDC/TMD) Patients willing to participate in this study.
排除标准
- •Five or more missing posterior teeth (except for the third molars) Parafunctional habits (bruxism and clenching) Impacted 3rd molars Degenerative joint disorder Patients with cardiac pacemakers, malignancy, or any other severe systemic illness Those patients who were not willing to undergo treatment.
结局指标
主要结局
To evaluate the efficacy of TENS and LLLT in reducing TMD-related pain.
时间窗: the outcome will be assessed at baseline, after 2 weeks & after 4 weeks.
To compare the effectiveness of TENS and LLLT.
时间窗: the outcome will be assessed at baseline, after 2 weeks & after 4 weeks.
次要结局
- To compare the effectiveness of TENS & LLLT(the outcome will be assessed at baseline, after 2 weeks & after 4 weeks.)
研究者
Dr DebasreeBoral
Dr. R Ahmed Dental College & Hospital