Chronic Neck PainNCT04630119
Prospective Analysis of Quality of Life, Presenteeism, and Emotional Health Due to Chronic Neck Pain in Homemakers
An observational study of Chronic Neck Pain, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Questionnaires on quality of life, emotional health and presenteeism
- How many people
- 67 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2019to 14 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: All female patients aged between 18-55 years with chronic neck pain (pain lasting for more than 3months) who were homemakers were included in the study. All participants reported presence of pain in the preceeding one week. Homemakers are defined as those who stay at home to care for the home or family. That is, a person irrespective of marital status (married, widowed, divorced, unmarried, separated) with or without children who manages a home and does not earn from employment from either a formal or informal sector.
Who may be able to join
- Patients of chronic neck pain (pain more than 3 months) Pain present in the last one week. Female gender. Homemakers Age between18-55 years
Who cannot join
- Pregnant. Uncontrolled diabetes and other co morbidities. Motor weakness of upper limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of Pre-treatment Quality of Life, Presenteeism, and Emotional Health Due to Chronic Neck Pain in Homemakers- An Indian Tertiary Care Hospital Perspective
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.
Read the detailed 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Questionnaires on quality of life, emotional health and presenteeism
- Keywords
- chronic neck pain,, homemakers, presenteeism, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires on quality of life, emotional health and presenteeismOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group of female homemakers with chronic neck pain | All female patients aged between 18-55 years with chronic neck pain (pain lasting for more than 3months) who were homemakers were included in the study. All participants reported the presence of pain in the preceding one week Receives: Other: Questionnaires on quality of life, emotional health and presenteeism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Visual analogue scale (VAS) is a valid, efficient and convenient measurement tool where subject was asked to mark his or her pain intensity in a 10 cm line divided in gaps of one cm. One end of the line represented no pain while the other signified the' maximum pain experienced by the subject in lifetime'.
Measured: 5 minutes
Secondary outcomes (3)
The Medical Outcomes Study Short-Form Health Survey (SF 36)
The Medical Outcomes Study Short-Form Health Survey (SF 36)is a widely used generic health-related quality of life (QoL) instrument. It has 36 questions measuring health in eight dimensions (physical functioning,role limitations due to physical health problems, bodily pain ,social functioning, general mental health covering psychological distress and well-being (MH), role limitations due to emotional problems , vitality, energy and fatigue and general health perceptions)
Measured: 15 minutes
Hospital anxiety and depression scale (HADS)
Hospital anxiety and depression scale (HADS) is a 14-item questionnaire which assesses both anxiety and depression (7 items each). The score of each subscale [anxiety or depression] can range from 0 to 21. It is used to assess the emotional status.
Measured: 5 minutes
Work functioning impairment scale) (WFI)
Work functioning impairment scale) (WFI) is a a six-item validated instrument that consists of four metrics: absenteeism, presenteeism, overall work productivity loss and activity impairment. Subject was asked to rate in a scale of 1-10 the amount the problem affected their productivity while working.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Oct 2019
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- MADHUSREE SENGUPTA, DNB, PDF, Principal investigator, CONSULTANT IN NEUROREHABILITATION AT INSTITUTE OF NEUROSCIENCES, KOLKATA, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630119
- Sponsor's protocol ID
- AIIMSRPR/IEC/2019/327
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via an email shared on this portal
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Pre-treatment Quality of Life, Presenteeism, and Emotional Health Due to Chronic Neck Pain in Homemakers- An Indian Tertiary Care Hospital Perspective
- ClinicalTrials.gov ID
- NCT04630119
- Acronym / sponsor ID
- AIIMSRPR/IEC/2019/327
- Conditions
- Chronic Neck Pain
- Keywords
- chronic neck pain,, homemakers, presenteeism, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group of female homemakers with chronic neck pain | – | Other: Questionnaires on quality of life, emotional health and presenteeismAll female patients aged between 18-55 years with chronic neck pain (pain lasting for more than 3months) who were homemakers were included in the study. All participants reported the presence of pain in the preceding one week |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All female patients aged between 18-55 years with chronic neck pain (pain lasting for more than 3months) who were homemakers were included in the study. All participants reported presence of pain in the preceeding one week. Homemakers are defined as those who stay at home to care for the home or family. That is, a person irrespective of marital status (married, widowed, divorced, unmarried, separated) with or without children who manages a home and does not earn from employment from either a formal or informal sector.
Key inclusion criteria (1 listed)
- Patients of chronic neck pain (pain more than 3 months) Pain present in the last one week. Female gender. Homemakers Age between18-55 years
Key exclusion criteria (1 listed)
- Pregnant. Uncontrolled diabetes and other co morbidities. Motor weakness of upper limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires on quality of life, emotional health and presenteeismAfter 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. | Other | Study group of female homemakers with chronic neck pain |
Primary outcome
Visual analogue scale (VAS)
Time frame: 5 minutes
Visual analogue scale (VAS) is a valid, efficient and convenient measurement tool where subject was asked to mark his or her pain intensity in a 10 cm line divided in gaps of one cm. One end of the line represented no pain while the other signified the' maximum pain experienced by the subject in lifetime'.
3 secondary outcomes
The Medical Outcomes Study Short-Form Health Survey (SF 36)
Time frame: 15 minutes
Hospital anxiety and depression scale (HADS)
Time frame: 5 minutes
Work functioning impairment scale) (WFI)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via an email shared on this portal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MADHUSREE SENGUPTA, DNB, PDF principal investigator
CONSULTANT IN NEUROREHABILITATION AT INSTITUTE OF NEUROSCIENCES, KOLKATA, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.