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临床试验/CTRI/2024/12/078643
CTRI/2024/12/078643已完成不适用

Effects of Dry Needling on Pain, Functional Limitations and Mouth Opening in Patients with Oral Sub-Mucous Fibrosis- A Pilot Study

KAHER institute of physiotherapy1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
To assess pain intensity using visual analog scale

研究概览

简要总结

Aim: To evaluate the effect of dry needling on pain, functional limitations, and mouth opening in patients with OSMF.

INCLUSION CRITERIA

• Patients willing to participate, between the age group of 18 and 60 years of all the genders diagnosed by OSMF grades 1 and 2 by the dentists.

• Mouth range of motion up to 35 to 25 mm.

EXCLUSION CRITERIA-

• All the red flags to dry needling

• Any coexisting infections around the face and neck, TMJ arthritis, occlusive disorders, fibromyalgia, or any neurologic disorder such as trigeminal neuralgia.

• Any systemic sickness or simultaneous condition that could affect the orofacial area and interfere with the study protocol.

• Injuries, use of anticoagulants or medications for circulation issues, metal allergies, and individuals with cognitive or communicative impairments that can impede the gathering of essential data

OUTCOE MEASURES

To assess pain intensity using visual analog scale

To assess mouth function limitations using the jaw functional limitations scales (JFLS-20).

To assess the mouth range of motion using Vernier caliper

PROCEDURE

Study participants will be screend for incusion and exclusion criteria. The pre and post-score will be measured.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

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 willing to participate, between the age group of 18-60 years of all the genders Diagnosed by OSMF grades 1 and 2 by the dentists.
  • Mouth range of motion up to 35 to 25 mm.

排除标准

  • All the red flags to dry needling Any coexisting infections around the face and neck, TMJ arthritis, occlusive disorders, fibromyalgia, or any neurologic disorder such as trigeminal neuralgia.
  • Any systemic sickness or simultaneous condition that could affect the orofacial area and interfere with the study protocol.
  • Injuries, use of anticoagulants or medications for circulation issues, metal allergies, and individuals with cognitive or communicative impairments that can impede the gathering of essential data.

结局指标

主要结局

To assess pain intensity using visual analog scale

时间窗: Day 1 pre and post

To assess mouth function limitations:The jaw functional limitations scales (JFLS-20)

时间窗: Day 1 pre and post

To assess the mouth range of motion using Vernier caliper

时间窗: Day 1 pre and post

次要结局

未报告次要终点

研究者

发起方
KAHER institute of physiotherapy
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sachi Yogesh Bhuse

KAHER Institute Of Physiotherapy

研究点 (1)

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