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临床试验/CTRI/2025/06/089291
CTRI/2025/06/089291尚未招募4 期

The efficacy of phonophoresis over conventional ultrasound therapy for pain relief in patients with Myofascial Pain Syndrome-a randomized control trial

DY Patil School of Dentisty1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年1月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
Reduction in tenderness on opening the mouth

研究概览

简要总结

AIM: To assess the comparative efficacy of phonophoresis over conventional ultrasound therapy in patients with myofascial pain syndrome.

OBJECTIVE:

Reduction in muscle tenderness

Reduction of pain on opening the mouth

Improvement in mouth opening

HYPOTHESIS: There is no difference in the efficacy of phonophoresis over conventional Ultrasound therapy in patients with myofascial syndrome.

METHODOLOGY:

STUDY DESIGN: Randomized control trial

STUDY DURATION: The study is expected to get completed in 1 months

STUDY POPULATION: Indian nationals in the age group of 18-60 years

INCLUSION CRITERIA: Patients in age group of 18-60 years

Patients who satisfy Laskins criteria for MPDS

Patients not taking any medications /alternate therapy for MPDS

EXCLUSION CRITERIA: Pregnant and lactating women, those with pacemakers, diclofenac allergy, the pain of odontogenic origin, neuralgias, neuromuscular disorders, already treated with anti-inflammatory, muscle relaxant, and analgesic drugs, intraarticular temporomandibular joint disorders, jaw tumors, and trauma.

SAMPLE SIZE: 26

SUBJECT SELECTION: Subjects visiting the OPD of the Department of Oral Medicine and Radiology and satisfying the Laskins criteria for MPDS will be enrolled in the study.

The patient will be informed about the research project and a written consent will be taken if the patient agrees to be a part of the study.

Randomization method: Patients will be allotted to one of the treatment arms through a simple random sampling method

TREATMENT DETAILS: The patients will be randomly divided into two groups of 13 patients each.

Group A will be treated with Ultrasound therapy with anti-inflammatory gel for 8 sittings of 8 minutes each over trigger points , with intensity of 1-1.5 watts per cm2 in continuous mode, Group B will be treated with with Ultrasound therapy without anti-inflammatory gel for 8 sittings of 8 minutes each over trigger points , with intensity of 1-1.5 watts per cm2 in continuous mode.

EXPECTED OUTCOME: Patients being treated with Ultrasound therapy along with anti-inflammatory gel are expected to have quicker/better relief.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients in age group of 18-60 years Patients who satisfy Laskins criteria for MPDS Patients not taking any medications /alternate therapy for MPDS.

排除标准

  • Pregnant and lactating women, those with pacemakers, diclofenac allergy, the pain of odontogenic origin, neuralgias, neuromuscular disorders, already treated with anti-inflammatory, muscle relaxant, and analgesic drugs, intraarticular temporomandibular joint disorders, jaw tumors, and trauma.

结局指标

主要结局

Reduction in tenderness on opening the mouth

时间窗: After 8 sessions spread over 8 days

Improvement in mouth opening

时间窗: After 8 sessions spread over 8 days

Reduction in individual muscle tenderness

时间窗: After 8 sessions spread over 8 days

次要结局

未报告次要终点

研究者

发起方
DY Patil School of Dentisty
申办方类型
Other [Private dental College]

研究点 (1)

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