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CTRI Number  CTRI/2021/10/037352 [Registered on: 18/10/2021] Trial Registered Prospectively
Last Modified On: 14/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Neck Pain in Students 
Scientific Title of Study   Risk Factors of Mechanical Neck Pain among Students 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tahsin Khan 
Designation  Student 
Affiliation  Bangladesh Health Professions Institute 
Address  Department of Physiotherapy, Bangladesh health Professions Institute (BHPI), Dhaka



1343
Other 
Phone  01684009968  
Fax    
Email  zovial.pixy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K M Amran Hossain 
Designation  Lecturer 
Affiliation  Bangladesh Health Professions Institute 
Address  Department of Physiotherapy, Bangladesh health Professions Institute (BHPI), Dhaka



1343
Other 
Phone    
Fax    
Email  amranphysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K M Amran Hossain 
Designation  Lecturer 
Affiliation  Bangladesh Health Professions Institute 
Address  Department of Physiotherapy, Bangladesh health Professions Institute (BHPI), Dhaka



1343
Other 
Phone    
Fax    
Email  amranphysio@gmail.com  
 
Source of Monetary or Material Support  
Bangladesh Health Professions Institute 
 
Primary Sponsor  
Name  Tahsin Khan 
Address  Department of Physiotherapy, Bangladesh Health Professions Institute (BHPI), CRP, Savar, Dhaka 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Md Shofiqul Islam   Bangladesh Health Professions Institute  Department of Physiotherapy, BHPI, CRP, Savar, Dhaka

 
01725145973

physio.shofiqul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of BHPI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M501||Cervical disc disorder with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  For case: University student with mechanical neck pain, pain more than 3 months, Pain is associated with neck movement, Pain can be the central or distal segment of the body, Activity of daily living is hampered for neck pain, Neck pain causing disability.
For control: University student without neck pain 
 
ExclusionCriteria 
Details  Pathological neck pain according to ICD 10, unwilling participants, suspicious or extreme responses.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale  more than 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Neck pain Disability Index  more than 3 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/10/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Aim

The aim of the study is to evaluate the risk factors of mechanical neck pain among the students.

 

Objectives

·         To find out socio-demographic information

·         To evaluate the association between neck pain and students

·         To exclude behavior, lifestyle, co-morbidity of sufferers and non-sufferers

·         To identify the physical factors

·         To detect association of schooling factors

·         To observe characteristics of neck pain

·         To perceive neck pain disability index

·         To discern the result of functional test


Study design

A perspective case-control study will be conducted. There will be an equal number of cases and control i.e. case: control will be 1:1.

 

Setting

Target population

University students will be selected for the study. Students with mechanical neck pain will be selected for the case group and students without mechanical neck pain will be selected for the control group.

 Study area

Universities of Dhaka city area.


Eligibility criteria

Inclusion criteria for case

·         University students with mechanical neck pain

·         Both male and female

·         Age: 18-26 years

·         Neck pain is present for at least more than 3 months

·         Pain is associated with neck movement

·         Pain can be central or referring to the distal segment of the body

·         Activity of daily living is being hampered for neck pain

·         Neck pain is causing disability


Inclusion criteria for control

·         University students without neck pain

·         Both male and female

·         Age: 18-26 years

·         Who had not been suffered from neck pain within the last 5 years

·         Who has never been treated for neck pain

·         Who share same exposure criteria that the case group has but not suffering from neck pain

Exclusion criteria for case

·         Unwilling to participate

·         Has the cognitive problem

·         Any kind of pathological condition such as- spondylosis, spondylolisthesis, osteoarthritis, listhesis, PCID, tumor, malignancy, pigget’s disease, sryingomyelia, chiari malformation, cervical stenosis) 

·        According to ICD-10:

Intensely discomforting, distressful, or agonizing sensation associated with trauma or disease, with well-defined location, character, and timing.

Pain is a feeling triggered in the nervous system. Pain may be sharp or dull. It may come and go, or it may be constant. You may feel pain in one area of your body, such as your back, abdomen or chest or you may feel pain all over, such as when your muscles ache from the flu. Pain can be helpful in diagnosing a problem. Without pain, you might seriously hurt yourself without knowing it, or you might not realize you have a medical problem that needs treatment. Once you take care of the problem, pain usually goes away. However, sometimes pain goes on for weeks, months or even years. This is called chronic pain. Sometimes chronic pain is due to an ongoing cause, such as cancer or arthritis. Sometimes the cause is unknown. Fortunately, there are many ways to treat pain. Treatment varies depending on the cause of pain. Pain relievers, acupuncture and sometimes surgery are helpful.

Pain that comes on quickly, can be severe, but lasts a relatively short time.

Physical suffering or distress, to hurt

Sensation of unpleasant feeling indicating potential or actual damage to some body structure felt all over, or throughout the body.

Severe pain of limited duration

The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve endings.

Unpleasant sensation induced by noxious stimuli and generally received by specialized nerve endings.

Unpleasant sensory and emotional experience arising from actual or potential tissue damage or described in terms of such damage (international association for the study of pain); sudden or slow onset of any intensity from mild to severe with an anticipated or predictable end and a duration of less than 6 months

Unpleasant sensory and emotional experience associated with actual or potential tissue damage.

 

Exclusion criteria for control

·         Unwilling to participate

·         Presence of neck pain

·        Unconscious and has cognitive problem

 

Sample size calculation

 100 cases and 100 controls.

Selection of case

The research will be started by identifying a group of people who have mechanical neck pain, typically called cases to conduct a case-control study. The researcher will select cases to find in predefined criteria. The patients with mechanical neck pain at universities of Dhaka city area will be used as the cases for this study.

Selection of control

The researcher will select the controls that will be free from neck pain. The relatively comparable sources of controls included the students of university. So similarly the investigator will select the controls who will not be affected by mechanical neck pain.

 Sampling technique

The researcher will choose a university-based random sampling technique. Considering the inclusion-exclusion criteria and the number of students it will be difficult to find the expected number of subjects. This technique will be feasible and suitable for the researcher to obtain relevant information according to study objectives.

 Data collection tools

 A structured questionnaire will be used for data collection by face to face or online interview. The questions will divided into key seven sections which almost covered all issues regarding risk factors of mechanical neck pain including age, sex, educational status, maritalstatus, residential area, hobby, educational environment, smoking habit, activity of daily living (ADL), obesity, lifestyle, anatomical texture of the body, interior designing of institute, posture. Besides this, a paper, pen and comprehensive field note would be used as the materials of data collection.

 Data management and analysis plan

Measurement of association

Exposure

Mechanical neck pain

Yes(Cases)

No(Controls)

Yes

a

b

No

c

d

Odds of exposure =a/c/b/d =ad/bc

                                                         Table: measurement of Odds ratio

In the case-control study, there will not be calculated the incidence rate of the disease so the actual relative cannot be obtained. The measure of the association between exposure and occurrence of the disease of the case-control study is the odds ratio. The ratio of odds of then exposure in diseased participants to the odds of the exposure in the non-diseased participants will be calculated as an odds ratio. According to the above mentioned an example for a calculated odds ratio.

SPSS 20 version will be used to analyze data. Data will be analyzed in the form of descriptive statistics for demographic data. 95% CI will be applied to show the significant between two variables. The odds ratio will be computed to determine how much risk there will in the presence of certain exposure compared to those who don’t have that exposure.

 Quality control and assurance

The investigator has enough knowledge in the designated study, hence the study area and underneath issues will be keenly explored. The format of the questionnaire will purely be structured, thus it has to enable a definitive answer. The questionnaire will be developed according to the literature search and peer review for a reliable questionnaire. The investigator will be tried to avoid selection bias due to strictly maintained inclusion and exclusion criteria.

Both cases and controls will be well defined in this study to avoid conflict in the selection of the case and control.

 Ethical considerations

 The whole process of this research project will be conducted by following the guidelines of Bangladesh Medical Research Council(BMRC), Institution Review Board(IRB) and World Health Organization(WHO) Research guidelines

Informed consent will be taken from all participants

   Participants’ rights and privileges will be ensured

   All the participants will be informed about the aim and objectives of the study

 No harmful act will be taken and the participant can withdraw themselves at any time

   Strictly will be maintained the confidentiality

Will have to right to proceed or withdraw from the study at any time of the respondents





 
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