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临床试验/CTRI/2024/03/063497
CTRI/2024/03/063497尚未招募不适用

Efficacy of Matrix Rhythm Therapy in Trismus among Smokeless Tobacco Users: A pilot study.

KLe Academy of Higher Education and Research1 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8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
Maximal intraincisal opening

研究概览

简要总结

Efficacy Of Matrix Rhythm Therapy in Trismus Among Smokeless Tobacco Chewers- A Pilot study

 Inclusion Criteria:

All genders.

•Ages between 19-65 years.

•Mouth opening limited to or less than 35mm

•Smokeless tobacco/ areca nut (betel nut) chewers for more than 10 years.

 Exclusion Criteria:

•Active infection

•Patients diagnosed with Head and neck cancer

•Unwilling participant

•Contraindications of Matrix Rhythm Therapy

-Open, inflamed or infected skin surfaces

-Fresh fractures

-Tendency for bleeding, hematoma formation

-Tendency towards embolism

-Pacemaker

-Mucous membranes

-Direct contact to bones

 METHODOLOGY:

•       Source of data: Community

•       Study design: Experimental

•       Duration of data collection: 3 months

•       Duration of study: 6 months

•       Place of study: Belagavi city

•       Target population: Smokeless tobacco consumers for more than 10 years

•       Sampling design: Non- Probability sampling

•       Sampling technique: convenience

Sampling size: 12

OUTCOME MEASURES:

1)Mouth opening: Maximal intraincisal opening (MIO)

2)Pain assessment: Visual Analogue Scale (VAS)

3)Quality of life and screening tool: Gothenburg Trismus Questionnaire

PROCEDURE

•      patients will be screened and then recruited as per the inclusion and exclusion criteria.

•     Participants will be briefed about the purpose of the study.

•     A written inform consent will be given to the participants in their own language and those consenting to participate in the study will be presented with the interventions.

•     Brief demographic data will be obtained from each participant prior to the assessment.

•     Pre-intervention:

•     MIO will be measured pretreatment using vernier caliper.

•     Pain will be evaluated using Visual Analogue Scale.

•     Outcome measures such as Gothenburg Trismus questionnaire, will be filled by the patients

•     The participants will be made to lie down comfortably in a supine position.

•     The area that will be treated are the muscles of the lower face and the anterior neck.

•     These areas will be well exposed and talcum powder will be applied over the treatment area to avoid the friction caused by the Matrix Mobil®

•     The application of Matrix Mobil will be given in a longitudinal stroking manner by pushing the probe of the device into the muscles of anterior and posterior neck, and entire face. The duration of every session will be 60 minutes for every subject.

•     Following two sessions of treatment with Matrix Rhythm Therapy, the Maximal interincisal opening and pain on VAS will be evaluated again, and any difference if present will be noted.

•     12 subjects will be receiving two sessions of MRT each.

•     Number of sessions: two sessions per week

•     Duration: 60 mins

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

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

入选标准

  • participants within age group 19-65 years 2)mouth opening limited to or less than 35mm 3) smokeless tobacco or areca nut chewer for more than 10 years.

排除标准

  • Active infection 2)Patients diagnosed with Head and neck cancer 3)Unwilling participant 4)Contraindications of Matrix Rhythm Therapy:Open, inflamed or infected skin surfaces -Fresh fractures -Tendency for bleeding, hematoma formation -Tendency towards embolism -Pacemaker -Mucous membranes -Direct contact to bones.

结局指标

主要结局

Maximal intraincisal opening

时间窗: 1 week

次要结局

  • Visual Analogue scale(for assessment of variation in intensity of pain)
  • Gothenburg Trismus Questionnaire(1 week)

研究者

发起方
KLe Academy of Higher Education and Research
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Varun Naik

KAHER INSTITUTE OF PHYSIOTHERAPY

研究点 (1)

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