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临床试验/CTRI/2025/07/090513
CTRI/2025/07/090513招募中2/3 期

Evaluation of efficacy of Transcutaneous Electric Nerve Stimulation, Therapeutic Ultrasound, Phonophoresis and Low level Laser Therapy in Management of Temporomandibular Disorders- A Comparative Study.

The Principal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
The results concluded that Low Level Laser Therapy showed significant improvement in all parameters like Pain score VAS, Helkimo Dysfunctional Index , and Maximum Mouth Opening followed by subjects of Th US, and the least improvement was noted in subjects with TENS therapy

研究概览

简要总结

The Temporomandibular Joint (TMJ) is a vital anatomical structure that connects the mandible (lower jaw) to the temporal bone of the skull. TMJ has a crucial role in monitoring the mandibular movements thereby controlling various essential daily tasks such as chewing, speaking, swallowing, and facial movements.

Temporomandibular Disorders (TMD) are a common musculoskeletal condition that cause significant discomfort and functional limitations. These disorders often manifest as chronic pain, joint dysfunction, & muscular stiffness, leading to difficulties in chewing, speaking, and performing daily activities.

As conventional pharmacological and surgical treatments have limitations or adverse effects, there is an increasing need for effective, non-invasive therapeutic approaches for the treatment of temporomandibular disorders.

Among the various physiotherapeutic modalities, Transcutaneous Electric Nerve Stimulation (TENS), Therapeutic Ultrasound (TUS), Phonophoresis, and Low-Level Laser Therapy (LLLT) have been widely utilized for pain relief and functional improvement in TMD patients.

These techniques offer different mechanisms of actions, including neuromodulation (TENS), deep tissue heating (TUS), enhanced drug absorption (Phonophoresis), and photo biomodulation (LLLT), all of which contribute to pain reduction and muscle relaxation.

However, despite their widespread use, there is a lack of consensus regarding their comparative effectiveness in managing TMD To assess the impact of these interventions, Visual Analog Scale (VAS) score will be utilized as outcome measures. The VAS score, on the other hand, is a validated tool for measuring subjective pain perception, providing insight into the patient’s pain experience and functional improvement. By integrating clinical (VAS) parameters, this study will provide a comprehensive evaluation of the therapeutic effectiveness of these modalities. The findings will help determine the most suitable non-invasive treatment for TMDs, contributing to evidence-based clinical decision-making and improved patient care.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Males and females of Age between 20 to 50 years will be enrolled as study group.
  • Patients with history of chronic TMJ pain for more than 1 month
  • Patients under GROUP 1 Myofascial Pain and GROUP 2 Disc Displacement of RDC TMD Criteria
  • Patients who are self-willing to participate are included in the study.

排除标准

  • Patients with the history of Pacemakers, recent trauma, open facial wounds, Implants in craniofacial region.
  • 2.Patients who are under regular medications such as muscle relaxants, anti- depressants, anti- convulsant, anxiolytics.
  • 3.Patients with history of any systemic disorders.
  • Patients with history of known allergies.
  • Patients with pain of odontogenic origin or arthrogenic pain as per (RDC/TMD Group III)
  • Patients who are previously treated with TENS, Th US, Phonophoresis, and LLT without improved conditions.
  • 7.Females who are pregnant or lactating will be ruled out.

结局指标

主要结局

The results concluded that Low Level Laser Therapy showed significant improvement in all parameters like Pain score VAS, Helkimo Dysfunctional Index , and Maximum Mouth Opening followed by subjects of Th US, and the least improvement was noted in subjects with TENS therapy

时间窗: All the above mentioned 4 modalities will be carried out for 2 times / week for 2 weeks

次要结局

未报告次要终点

研究者

发起方
The Principal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Harshita Arabbi

PMNM Dental College and Hospital

研究点 (1)

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