NCT04630119

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 9, 2020

Last Update Submit

November 9, 2020

Conditions

Keywords

chronic neck pain,homemakerspresenteeismquality of life

Outcome Measures

Primary Outcomes (1)

  • 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'.

    5 minutes

Secondary Outcomes (3)

  • The Medical Outcomes Study Short-Form Health Survey (SF 36)

    15 minutes

  • Hospital anxiety and depression scale (HADS)

    5 minutes

  • Work functioning impairment scale) (WFI)

    5 minutes

Study Arms (1)

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

Other: Questionnaires on quality of life, emotional health and presenteeism

Interventions

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 of female homemakers with chronic neck pain

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall-female patients who are home makers
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients of chronic neck pain (pain more than 3 months) Pain present in the last one week. Female gender. Homemakers Age between18-55 years

You may not qualify if:

  • Pregnant. Uncontrolled diabetes and other co morbidities. Motor weakness of upper limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neurosciences Kolkata

Kolkata, West Bengal, 700017, India

Location

MeSH Terms

Interventions

Mental HealthPresenteeism

Intervention Hierarchy (Ancestors)

HealthPopulation CharacteristicsPsychology, IndustrialPsychologyBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • MADHUSREE SENGUPTA, DNB, PDF

    CONSULTANT IN NEUROREHABILITATION AT INSTITUTE OF NEUROSCIENCES, KOLKATA, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

October 1, 2019

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

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

Locations