Neck Pain in Students

• Conditions: Cervical disc disorder with radiculopathy,

• Registration Number: CTRI/2021/10/037352
• Lead Sponsor: Tahsin Khan

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-10-14
• Study Start: 2021-10-18

Recruitment & Eligibility

• Status: Not Applicable
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

Pathological neck pain according to ICD 10, unwilling participants, suspicious or extreme responses.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	more than 3 months

Secondary Outcome Measures

Name	Time	Method
Neck pain Disability Index	more than 3 months

Trial Locations

Locations (1)

Bangladesh Health Professions Institute; 🇮🇳 Savar,, India

Bangladesh Health Professions Institute

🇮🇳Savar,, India

Md Shofiqul Islam

Principal investigator

01725145973

physio.shofiqul@gmail.com