Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04630119 |
| Other study ID # |
AIIMSRPR/IEC/2019/327 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
January 14, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
National Institute of Mental Health and Neuro Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Chronic pain is defined as persistent or recurrent pain lasting longer than 3 months as per
ICD11 and includes seven categories of pain. Chronic musculoskeletal pain is one of them.
Neck pain is one of the top five causes of chronic pain yet few clinical trials are dedicated
solely to neck pain. Chronic neck pain not only leads to neuromuscular dysfunction but also
psychological distress and fear-avoidance all contributing to reduced quality of life,
emotional health, and productivity of a person. Absenteeism and presenteeism are both
measures of work productivity of a person but presenteeism is more significant where being
absent from work is not a feasible option like in the case of homemakers.
Homemakers are often neglected but they constitute an essential part of society. Although
they do not have a formal occupation, they perform a multitude of ergonomically stressful
activities leading to different types of musculoskeletal pain. Being mostly a silent
sufferer, they often seek medical help when the pain becomes chronic and affects different
areas of health thereby necessitating a holistic management approach.
In the Central Indian cultural scenario, a homemaker rarely takes complete rest from her
household chores. So presenteeism can be used as a marker for work productivity. This study
aims to analyze the impact of chronic neck pain in the pre-treatment quality of life,
presenteeism, and emotional health in homemakers and to find the association of the findings
with the cause and severity of chronic neck pain.
Description:
Chronic pain is defined as a persistent or recurrent pain lasting longer than 3 months as per
ICD11 and constitutes of seven categories of pain including musculoskeletal pain. Neck pain
is one of the top five causes of chronic pain which globally affects 332 million and ranks
4-6th as a cause of Years Lived with Disability. It has been described by the Bone and Joint
Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders as 'pain located in the
anatomical region of the neck with or without radiation to the head, trunk, and upper limbs.
Chronic neck pain not only leads to neuromuscular dysfunction but also psychological distress
and fear-avoidance all contributing to reduced quality of life and emotional health.
Chronic pain expectedly affects the work productivity of an individual. Work productivity is
measured by either 'absenteeism' or 'presenteeism'. Absenteeism (absence from work) is
calculated by missed days at work and presenteeism means being present at work while
experiencing health complaints or to put it simply 'not unwell enough" to skip work when
sick. Presenteeism is commonly interpreted through various scales of pain, cognition, and
quality of life. The highest rate of presenteeism across various sectors has been reported in
human service organizations that deal with care, welfare, and education. The last decade has
seen a surge in interest in presenteeism and the concept has received both positive and
negative criticism. High presenteeism ensures excellent attendance at work but also signifies
a higher workload and poor work-life balance along with variations in personal work ethics.
Presenteeism has been variously studied across different disease conditions and specific
ergonomic populations but there are very limited studies on homemakers.
Homemakers along with students and retirees are considered a part of the Out of the labor
force (OLF) of the society who do not have an income and are hence formally unemployed.
However, in a patriarchal society like India, women homemakers often perform a multitude of
roles (parental, caretaker, household) which are comparable to that of paid domestic help and
can be classified as an occupation on its own. Observing from an ergonomic point of view,
homemakers engage in activities that involve prolonged awkward postures as well as repetitive
movements which are risk factors for various musculoskeletal pain of the neck, back, and
limbs. But unlike other professions, there is no externally imposed time frame or formal
'breaks' which prevents a homemaker from taking a leave. Thus despite the biomechanical and
psychosocial stress, homemakers continue their chores and seek help only when the pain is
chronic and unbearable. So presenteeism instead of absenteeism is a more appropriate and
reliable marker for work productivity amongst homemakers.
Although there are studies to see the prevalence of neck pain in the world, there are few
clinical studies dedicated solely to neck pain especially in a specific population of
homemakers more so in Central India.
The aim of this study was to analyse the impact of chronic neck pain in the pre-treatment
quality of life, presenteesism and emotional health in homemakers and to find the association
of the findings with the cause and severity of chronic neck pain.
All patients who met the inclusion criteria were approached with the study. After obtaining
informed consent, a pro forma consisting of the socio-demographic details and pre-treatment
assessment questionnaire (including Visual analog scale The Medical Outcomes Study Short-Form
Health Survey The hospital anxiety and depression scale Work functioning impairment scale)
was filled for each subject. The record was maintained based on a serial number given to each
patient. Routine blood investigations (complete blood count, fasting blood sugar, renal,
liver, and thyroid function test was done for all. X-ray of the cervical spine (AP and
Lateral views) was prescribed. The final diagnosis was noted in subsequent follow-ups at OPD
.
The results were then co related with the cause of chronic neck pain.
