Efficacy of Matrix Rhythm Therapy in Trismus among Smokeless Tobacco Users: A pilot study.
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
Varun Naik
KAHER INSTITUTE OF PHYSIOTHERAPY
