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临床试验/CTRI/2024/03/064774
CTRI/2024/03/064774尚未招募不适用

Comprehensive risk factor analysis and effect of novel postural correction intervention on physical function in dentists with mechanical spine pain -A mixed method study

Victoria Kuttan MGM School of Physiotherapy MGM Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2024年4月1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
354
试验地点
1
主要终点
Designed Survey tool will be administered to measure intrinsic and extrinsic risk factors

研究概览

简要总结

In the present mixed method, study participants will be included as per the inclusion and exclusion criteria. The cross-sectional part of the study aims to study the comprehensive intrinsic and extrinsic risk factors for developing mechanical spine using a survey tool and clinical tests to assess pain, posture and physical function in 354 dentists. A survey tool will be formulated using the Delphi method and then tested for validity and reliability. 60 dentists a subset of the 354 dentists (30 with and without mechanical spine pain) will be analysed biomechanics for different operatory procedures.

A novel postural device will be developed based on focus group discussions with electronic engineers and dentists with various specialties and pilot tested with 10 dentists without mechanical spine pain to provide real-time kinesthetic awareness. The device development will be as per the steps for medical device innovation.

The experimental hypothesis is that Novel posture correction device and conventional physiotherapy intervention will be more effective in reducing pain and improving physical function compared to conventional physiotherapy intervention in dentists with mechanical spine pain.

The experimental part of the study a total of 72 dentists with mechanical spine will be participating. The participants will be randomly allocated into experimental and conventional group using computed generated random number tables and allocation will be concealed using Sequentially numbered opaque sealed envelope(SNOSE). The participants in the experimental group will be given the novel postural correction device to be used during work hours for at least 3-4 hours a day, 3-5 days a week for 12 weeks along with conventional physiotherapy exercise. The participants in the conventional group will receive conventional physiotherapy exercise. The conventional physiotherapy exercise will be administered 4 times /week for 12 weeks

One supervised session and three telemetric sessions (through online platform)of including 20-30 minutes exercises with rest breaks of 30 second between each exercise and 10 minutes of cognitive behavioral therapy. Physiotherapy intervention includes – warm up, stretching, strengthening and sensorimotor training and cognitive behavioral therapy cool down. Ergonomic advice manual will be shared with the participants and an education session will be held once a month for 3 months for both the groups.

Participants will be analysed for all the outcome measure for pain, posture and physical function at baseline, 4 weeks, 8 weeks and 12 weeks of clinical test.

Data of the experimental group will be statistical analysed within and between the groups.

The result of the study will help in developing an algorithm for risk factor stratification and early identification of mechanical spine pain in dentists. Intervention - will benefit in reducing pain and improving physical function. A guideline booklet will be formulated will the help of study findings which would include all the ergonomic advises and exercises specific to task for the dentists community.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
23.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Dentists registered under Dental Council of India and practicing dentistry Male and female in the age group of 23 to 50 years Dentist with mechanical spine pain Dentist who are willing to participate in the study.

排除标准

  • Dentists with VAS Score more than 7 at time of evaluation who are experiencing pain while performing the physical function Dentists having any known disorder of the musculoskeletal disorder such as Rheumatoid Arthritis, Ankylosing Spondylitis and others systemic disease affecting the musculoskeletal system.
  • Severe uncontrolled cardiopulmonary disorder’s or conditions, neurological conditions (in whom test performance is not possible) and psychological disorders unable to comprehend instructions.
  • Dentists having history of traumatic injury to the upper quadrant and low back Dentists with history of surgery to spine, upper extremity joints in the past one year Dentist who are pregnant.

结局指标

主要结局

Designed Survey tool will be administered to measure intrinsic and extrinsic risk factors

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Two dimensional and three dimensional Kinematics of dental posture for different

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Muscle activity (Fatigue of neck upper back , low back muscles)

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Postural angle of the spine

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Posture analyis using RULA

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Pain using Visual Analogue scale and

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Back core muscle strength

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Muscle flexibility

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Joint position sense measurement

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Manual dexterity

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Hand function

时间窗: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

次要结局

  • Modiefied Oswestry Scale(MODQ)(Neck Disability Index(NDI))

研究者

发起方
Victoria Kuttan MGM School of Physiotherapy MGM Institute of Health Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Victoria Kuttan

MGM School of Physiotherapy MGM Institute of Health Sciences

研究点 (1)

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