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临床试验/CTRI/2024/01/062070
CTRI/2024/01/062070尚未招募2 期

Comparative Evaluation of Therapeutic Ultrasound and Transcutaneous Electrical Nerve Stimulation in Myo-Facial Pain Dysfunction Syndrome A Randomized control trial

NISHA MADDHESHIYA1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
Numeric Rating Score (NRS) at baseline

研究概览

简要总结

The study is randomized parallel control trial comparing the numeric rating scale at baseline  along with maximal mouth opening and lateral movement of the jaw in MPDS patients.

A total of 46 subjects has been  taken in two divided groups randomly according to the inclusion criteria and the study will be explained to them before starting the treatment.

Group A Subjects will receive TENS for the duration of 15 min per session thrice a week for 4 weeks. Patient will be followed up for another 4 weeks after completion of treatment. The stimulation will be given to the patient in sitting position; surface electrodes will be placed on tender muscles of face and neck region.

Group B Subjects will receive continuous and manual mode ultrasound therapy at frequency of 3.0 MHz at 1.4 W/m2 to the area of interest for the duration of 15 min per session thrice a week for 4 weeks and patient will be followed up for another 4 weeks after completion of treatment.

Numeric rating score (NRS) will be recorded at baseline and after each follow up period. Maximum mouth opening and lateral movement of jaw in terms of mm will be recorded at baseline and after completion of treatment.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from MPDS Patients presenting with pain trismus and clicking without any radiological and pathological findings.

排除标准

  • Patients with recent TMJ dislocation, hairy surface, radiculopathy, or other neurological deficits.
  • Patients on any medication for MPDS Patients undergone any cardiac surgery or any other systemic illness.
  • Pregnancy or breastfeeding women Patients with other orofacial pain disorders.

结局指标

主要结局

Numeric Rating Score (NRS) at baseline

时间窗: Numeric Rating Score (NRS) at baseline and after each follow-up.

次要结局

  • Maximum Mouth opening (in mm) measured at baseline and after completion of treatment.(Lateral movement of the jaw (in mm) measured at baseline and after completion of treatment.)

研究者

发起方
NISHA MADDHESHIYA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nisha Maddheshiya

Faculty of Dental Sciences IMS BHU Varanasi

研究点 (1)

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Comparison of TENS and Ultrasound in MPDS | 临床试验