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Clinical Trials/CTRI/2024/03/064774
CTRI/2024/03/064774Not yet recruitingNot Applicable

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 site in 1 country354 target enrollmentStarted: April 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
354
Locations
1
Primary Endpoint
Designed Survey tool will be administered to measure intrinsic and extrinsic risk factors

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
23.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

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

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Postural angle of the spine

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Posture analyis using RULA

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Pain using Visual Analogue scale and

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Back core muscle strength

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Muscle flexibility

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Joint position sense measurement

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Manual dexterity

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Hand function

Time Frame: Cross sectional study – Baseline | Experimental study – baseline, 4 weeks , 8 weeks and 12 weeks

Secondary Outcomes

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

Investigators

Sponsor
Victoria Kuttan MGM School of Physiotherapy MGM Institute of Health Sciences
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Victoria Kuttan

MGM School of Physiotherapy MGM Institute of Health Sciences

Study Sites (1)

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