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临床试验/CTRI/2023/08/056466
CTRI/2023/08/056466尚未招募Phase 3 4

Comparative Evaluation Of Effectiveness Of Therapeutic Ultrasound And Pulsed Shortwave Therapy Along With Physiotherapy In Management Of Temporomandibular Disorders: A Randomized Controlled Trial.

Dr Shraddha Damodar Chincholkar1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年8月21日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Pulsed short wave therapy with physiotherapy is more effective than therapeutic

研究概览

简要总结

COMPARATIVE EVALUATION OF EFFECTIVENESS OF THERAPEUTIC ULTRASOUND AND PULSED SHORTWAVE THERAPY ALONG WITH PHYSIOTHERAPY IN MANAGEMENT OF TEMPOROMANDIBULAR DISORDERS: A RANDOMIZED CONTROLLED TRIAL.

A consecutive sample of 48 subjects fulfilling eligibility criteria and seeking treatment and care at the study hospital will be selected by convenience sampling method and equally allotted to two study groups. The 24 subjects will be equally allocated into 2 groups

i) Group A - Patients undergoing therapeutic ultrasound with physiotherapy.

ii) Group B - Patients undergoing PSWT with physiotherapy.

A detailed case history will be taken from all the patients and will be recorded in the predesigned proforma after patients written consent and approval from the Institutional ethical committee. Only those patients who are willing to participate will be considered in the study.

Total 48 clinically diagnosed patients with Temporomandibular disorders will be enrolled in the study. All the patients will be explained the need and design of study.

Diagnosis of TMD was made based upon research diagnostic criteria (RDC) for clinical TMDs conditions.

Group A patients (24 subjects) will be given Therapeutic Ultrasound which comprises of single session of 8 min, once a week for 4 consecutive weeks.

Group B patients (24 subjects) will be given Pulsed Short-Wave Therapy for 60 min per day over 5 consecutive days.

Pain will be evaluated using VAS and Mouth opening will be measured using a Electronic Vernier calliper on baseline, 2 nd ,3rd, 4th weeks in both groups.

Physiotherapy exercises will be advised to the patient which includes isometric mouth exercises, mouth stretching exercises, and resistive mouth exercises, with each exercise to be performed for 6 seconds with 10 repetitions, for 4 weeks.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients aged above 18 years.
  • Patients with symptomatic temporomandibular disorder along with reduced mouth opening diagnosed with Myositis and myofascial pain dysfunction syndrome.

排除标准

  • Traumatic conditions of TMJ region.
  • Patients with degenerative diseases involving TMJ.
  • Patients with any congenital defect in TMJ.
  • Patients with cardiac pacemakers and cardiac arrhythmias.
  • Pregnant women.
  • Patient suffering from benign and malignant neoplastic condition of TMJ disorders, mentally disabled patients.
  • Patients with undiagnosed dental pain or who have skin lesions or facial abrasion at the site of acoustic gel placement.
  • Patients not willing to participate in the study.

结局指标

主要结局

Pulsed short wave therapy with physiotherapy is more effective than therapeutic

时间窗: Pain will be evaluated using VAS & Mouth opening will be measured | using an Electronic Vernier calliper on baseline, 2 | nd ,3rd, 4th weeks in both | groups. | Physiotherapy exercises will be advised to the patient which includes | isometric mouth exercises, mouth stretching exercises, & resistive | mouth exercises, with each exercise to be performed for 6 seconds with | 10 repetitions, for 4 weeks.

ultrasound with physiotherapy in management of TMD

时间窗: Pain will be evaluated using VAS & Mouth opening will be measured | using an Electronic Vernier calliper on baseline, 2 | nd ,3rd, 4th weeks in both | groups. | Physiotherapy exercises will be advised to the patient which includes | isometric mouth exercises, mouth stretching exercises, & resistive | mouth exercises, with each exercise to be performed for 6 seconds with | 10 repetitions, for 4 weeks.

次要结局

  • To evaluate & compare the effectiveness of PSWT & Therapeutic ultrasound(along with physiotherapy in management of TMD in terms of pain relief &)

研究者

发起方
Dr Shraddha Damodar Chincholkar
申办方类型
Other [self]

研究点 (1)

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