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

Response - NO

⦁ PROJECT SUMMARY

The study aims to find the effect of sitting duration on chronic lower back pain complaints in

bike riders affecting the quality of life among bike riders in urban Bangalore population. The

study is a survey study with sample size of 125 participants which will be conducted among

the bike riders with low back pain which affects their quality of living. The outcome

measures used in study are as follows the visual analog scale is an outcome measures used

mainly to assess the pain intensity which ranges from 0-10 (in numerical basis). The

Oswestry low back pain disability questionnaire (OLBPDQ) used to find out the rate of

disability. Total scores of OLBPDQ ranged from 0-50 with the higher values showing that

the severity of disability. The Roland Morris questionnaire (RMQ) it is a disability measure

in which greater levels of disability are reflected by higher numbers on a 24-point scale. The

time of assessment will be 15-25 minutes (time to reflect on questionnaire and to answer

accordingly).

INTRODUCTION & BACKGROUND

 Low back pain (LBP) is one of the most commonly encountered medical

conditions in the present era and arises as a clear global public health issue in all kinds of

economical countries. 54% of LBP progression has been notified from the year between 1990

and 2015 globally . 1 Low back pain is a leading problem in bike riders and is increasing day

by day due to faulty posture during bike riding. The lower back region starts from the rib

cage and ends up at the gluteal folds. Vertebrae located in this region are called lumber

vertebras that have inward curvature which is called lordosis .2

The Lumbar spine has 5 vertebras numbered L1-L5, which are large and well-located because

of their functions. In the lumbar spine, the last two segments, L4-L5 and L5-S1 carry the

most weight and movement of the body due to which they are more prone to injury. Eachnerve root is closely related to the medial and inferior aspects of the adjacent vertebral

pedicle, with anomalies excluded. 3

There are fixed boundaries of the intervertebral foramen, although its dimensions vary

depending on the height of the individual disc spaces. It is bound by the vertebral pedicles

above and below. At the end of the passage, the intervertebral foramen is analogous to the

doorway, its vertical height is determined by the vertical height of the corresponding

intervertebral disc space. Low back pain is the key cause of restriction of operation and

absence of work in most of the world, placing an immense economic strain on citizens,

families, societies, industry, and governments. 2, 3

Motorbikes are the most price-reducing and fuel-efficient mode of transport but this they

cause postural stress and psychological stress which leads to an increase in the number of

road accidents, as due to long hours of driving there is a loss of sensation in the saddle area,

and cause of low back pain, due to incorrect posture and nerve compression due to awkward

sitting positions, physiological comfort of the bike seat is neglected but style and looks of the

bike are preferred more which later on cause long term lower spine problems. 5

A two-wheeler rider along with the two-wheeler can be considered as a constrained

workstation. During a journey, the rider will sit nearly in the same posture throughout the

ride. The factors like design parameters of the two-wheeler such as height, location, and

angle of the foot, seat, handlebars, and the physical dimensions of the rider decide the

posture. A human operator will experience discomfort on any workstation on continuous

exposure to a single posture. 3

Two-wheeler riders are exposed to a more static position with restrictions in movements, for

a very long period depending on the usage. Sitting in the same posture for a long time will

result in a restriction in blood flow, which causes distress to body parts causing muscle

stiffness and thereby discomfort .3

Low back pain (LBP) was the most reported symptom denoted by a higher prevalence of

82.3% and longer duration of LBP together with a higher percentage of absenteeism from

work due to LBP. After adjusting for the effects of demographic characteristics and lifestyle

factors, we found that riding time and posture were the major factors significantly associated

with higher LBP prevalence in motorbike riders. 4

Lower back pain complaints are a very common world health issue, which results in

restriction of activity as well as an absence from work. Many factors are associated withlower back pain complaints such as body mass index (BMI), height, exercise habits, work

time, work position, and workload. 5

The average human spends a third of his life at work. The increasing number of workers,

including motorbike riders, increases the incidence of lower back pain complaints.

 Lower back complaints are not a disease or diagnosis but are a term for pain that is felt in

certain anatomical areas of the human body with various variations in the duration of pain.

Based on The Global Burden of Disease 2010 Study (GBD 2010) 1 of 291 diseases studied,

Lower back pain complaints are the biggest contributor to global disability. 5,6

Base motorbike riders have the risk of being exposed to physical factors when working. In

addition, the sitting duration also has a share in the emergence of lower back pain complaints.

Lower back pain does not cause death, but cause individuals who experience it to be

unproductive so it will cause a very large economic burden for individuals, families,

communities, and the government. According to WHO, lower back pain can be caused by

various musculoskeletal diseases, psychological disorders, and wrong mobilization. Based on

the duration of complaints experienced, lower back pain can be divided into acute lower back

pain and chronic low back pain .7

In the field of physiotherapy and rehabilitation, strength or resistance, coordination or

stabilization exercise, endurance exercise, stretching exercises, and occupational modification

like rest breaks or intervals between rides are playing an effective progression role for LBP. 8,9

Professionals are maintained a long time in a single position or the same posture in a day. In

that case, proper posture, timely postural change, and taking rest breaks or intervals are

highly effective to reduce LBP, and discomfort as well as enhancing the productivity of the

work also.

This study is aimed to find the effect of sitting duration on chronic lower back pain

complaints in bike riders affecting the quality of life among bike riders in urban Bangalore. 9,10

LACUNAE IN LITRATURE

As evident from the above literature review, currently, there is a lack of research regarding

the prevalence of low back pain affecting the quality of life among the two-wheeler/ bike

riders in the urban Bangalore population. Although there is treatment/intervention for the

condition the low back pain, the most common condition of low back pain among individuals

who use a bike as their daily mode of transportation is still unaddressed. Thus a cross-

sectional study like a survey study needs to be performed.  Realizing this need, the current

study has been proposed.

RESEARCH QUESTIONS 

How the quality of life is affected among the individuals who use a bike as a daily mode of

transport?

How much is the prevalence of people with low back pain which affects their quality of

living in the urban Bangalore population?

How does the mutuality between long duration sitting while bike ride which leads to low

back pain and how it affects the quality of life?

AIMS AND OBJECTIVE 

Aim of the study:

This study is aimed to find the effect of sitting duration on chronic lower back pain

complaints in bike riders affecting the quality of life among bike riders in urban Bangalore.

Objective of the study:

The objective of the study is to study that the Motorbike has been one of the vital modes of

transportation worldwide. It is difficult to identify and address the low back pain among

motorbike riders that cause muscular discomfort and leads to poor quality of living among

motorbike riders due to not much research having been carried out on motorbike riders. To

find out the prevalence of low back pain in motorbike riders which is affecting the quality of

life among the urban Bangalore population.

MATERIALS AND METHODS

This section should include the following 

Study area: SPARSH trauma centre – physiotherapy OPD, Narayana Health City

Study design: Cross-sectional survey study

Study population: participants with low back pain for at least one episode.

Sample size: 125 subjects

Sample size calculation:

Sample Size Estimation

Formula

α=0.01, 99% CI, Proportion P=75%, d=0.1,

n=125.

From review of literature, Low back pain (LBP) is one of the most commonly encountered

medical conditions in the present era and arises as a clear global public health issue in all

kinds of economical countries. Low back pain (LBP) was the most reported symptom

denoted by a higher prevalence of 82.3% .Based on this information taking 75% prevalence

at 5% level of significance and 10% estimated error, the minimum required sample size will

be 125. 23

As the stud focus on the prevalence of low back pain affecting the quality of life among the

bike riders using the VAS scale, OLBPDI questionnaire, Roland Morris disability index as

outcome measures the study is carried out.

Study duration: Study duration will be commenced after ethical committee approval.

SELECTION CRITERIA:

Inclusion criteria

• Age group between 18-45 years

• A History of at least 1 significant low back pain

• Participants Both male and female

• Participants riding a bike for at least one year

• Participants rides bike for at least 1 to 5 hours per day

• Participants with low back pain which restrict their range of motion and affect their

daily activities.

Exclusion criteria

• Participants with inflammatory disorders

• Participants with malignancy

• Participants with polymyalgia

• Participants with spinal epidural abscess

• Participants with osteomyelitis

• Participants with spondylitis.

Materials required:

• Forms of outcome measures 

• Pencil and pen

• Calculator

Methodology

The Participants who fulfils the inclusion criteria and are willing to participate in the study

would be participating in the study.

This study uses a cross-sectional/cross-section study design to identify the relationship

between motor and long-term motorbike exposure to chronic lower back pain complaints. 

The target population of this study would be the motorbike riders in urban Bangalore. 2

The severity of LBP will be measured by the oral declaration of subjects and rated by a

colour 10 cm visual analog scale (VAS). The severity range would be from 0 to 10 cm and

motorbike riders would be asked to mark their pain in VAS. 21

Roland Morris questionnaire (RMQ) it is a self-administered disability measure in which

greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has

been shown to yield reliable measurements, which are valid for inferring the level of

disability, and to be sensitive to change over time for groups of patients with low back pain.

The patient is instructed to put a mark next to each appropriate statement. Add up the total

number of marked statements to get a patient’s score. Roland and Morris did not provide

descriptions of the varying degrees of disability (eg, 40%-60% is severe Disability). Clinical

improvement over time can be graded based on the analysis of serial questionnaire Scores. 19, 21

The Oswestry low back pain disability questionnaire (OLBPDQ) are selected as a standard to

find out the rate of disability. Total scores of OLBPDQ ranged from 0-50 with the higher values showing that the severity of disability consists of 10 items and each of them scaled

from 0-5. 9

The selection of prospective respondents starts by providing information about the aims and

objectives of the study. Respondents who are willing to fill out an informed consent

questionnaire will be explained the procedure for filling out the questionnaire. 20, 21

The visual analog scale (VAS), Roland Morris questionnaire (RMQ), The Oswestry low back

pain disability questionnaire (OLBPDQ). These outcome measures are free to use and does

not require permission for access to use for the study. 

Method of measurement of outcome measures:

1. VAS scale,

2. OLBPDI questionnaire,  

3. Roland Morris disability index.

The subjects who fulfil the inclusion criteria and are willing to participate in the study will be

assigned to one of two groups after obtaining written informed consent.

STATISTICAL METHODS

Data will be analysed using SPSS software. Baseline patient characteristics will be described

using mean and SD for continuous variables; frequency and percentage for categorical

variables. P value less than 0.05 will be considered statistically significant .23

ï‚· The frequency and percentage will be used to present the proportion of the subjects.

ï‚· The descriptive statistics range, mean, and standard deviation will be used to describe

the pre and post-outcome measures in both groups.

ï‚· The data will be represented by a graphical representation based on the prevalence

calculated

ETHICAL CONSIDERATION

Ethical clearance will be obtained before the study from the ethics committee of the

institution. 

Informed consent will be obtained from parents/guardians before the onset of the study. 

Confidentiality of patient details will be maintained. 

As this study does not involves the application of the treatment on the human subject.

The study does not involve any extra procedure, and no compensation will be offered during

and after the study.