| CTRI Number |
CTRI/2025/11/097536 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey to understand how work habits and daily activities affect back pain in home-based women entrepreneurs. |
|
Scientific Title of Study
|
Identification of factors affecting non specific low back pain in home based female entrepreneurs: A cross-sectional Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ambreen Almas |
| Designation |
MPT student |
| Affiliation |
Amity Institute of health allied and sciences |
| Address |
Amity Institute of Health Allied and sciences, Amity University Noida Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9113303370 |
| Fax |
|
| Email |
ambreenalmass@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of health allied and sciences, Amity university Noida |
| Address |
Department of physiotherapy, Amity Institute of health allied and sciences, Amity University Noida Uttar Pradesh SEC 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Kumar |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of health allied and sciences, Amity university Noida |
| Address |
Department of physiotherapy, Amity Institute of health allied and sciences, Amity University Noida Uttar Pradesh SEC 125
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Amity institute of Health Allied and Sciences, F1 LGF, Sector 125, Noida |
|
|
Primary Sponsor
|
| Name |
Ambreen Almas |
| Address |
Amity institute of health allied sciences, Amity university Noida Uttar Pradesh India 201313 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ambreen Almas |
Amity Institute of Health Allied Sceinces |
Amity Institute of Health Allied and sciences, Amity University Noida Uttar Pradesh India 201313
Gautam Buddha Nagar
UTTAR PRADESH |
09113303370
ambreenalmass@gmail.com |
| Dr Pragya Kumar |
Amity University |
Amity University, Noida Sec 125 Uttar Pradesh - 201313
Gautam Buddha Nagar
UTTAR PRADESH |
9878529787
pkumar24@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee |
Approved |
| Institutional NTCC committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M53||Other and unspecified dorsopathies, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects aged between 18 and 50 years.
Home-based business entrepreneurs.
Engaged in sedentary work (e.g., tutoring, writing, designing, content writing, data entry) for at least 4 hours per day.
May or may not have non-specific low back pain (NSLBP).
If NSLBP is present, duration should be more than 1 week but less than 12 weeks.
Willing to provide informed consent.
Able to read, understand, and complete the questionnaire independently. |
|
| ExclusionCriteria |
| Details |
Diagnosed with a specific cause of low back pain (e.g., spinal fracture, infection, malignancy, herniated disc).
Presence of neurological symptoms (e.g., radiculopathy, bowel or bladder dysfunction).
Pregnant women.
History of psychiatric illness or currently undergoing psychological treatment.
Incomplete or inconsistent responses in the questionnaire. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain: Measured using the Visual Analog Scale (VAS), where participants rate their low back pain from 0 (no pain) to 10 (worst pain possible). |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Psychological Stress: Measured using the Cohen’s Perceived Stress Scale (PSS-10).
Physical Health: Measured through height, weight, BMI, daily sleep hours (self-reported), & weekly moderate/strenuous physical activity (self-reported).
Quality of Life: Assessed using the WHOQOL-BREF questionnaire.
Demographic Details: Collected via standardized questionnaires, including age, education, employment, income, smoking, alcohol use, & comorbidities.
Social Factors: Assessed via questionnaire, including household workload, ergonomic work conditions, social isolation, access to healthcare, & role-related stressors. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need of the Study
Low back pain is one of the most common problems among working women. However, very little attention has been given to home based female entrepreneurs who spend long hours sitting, working in poor posture, and managing both business and household duties. These women often face physical strain, stress and lack of support which may increase their risk for non specific low back pain. There is a need to explore how factors like age, lifestyle, mental stress, quality of life, physical health, and pain affect their back health. Identifying these factors can help in designing better awareness programs, preventive strategies, and support systems for this under researched group. Aim
To identify the factors associated with non specific low back pain in home based female entrepreneurs using a cross sectional approach. Objective The objectives of this study are to identify the prevalence of non specific low back pain among home based female entrepreneurs, to evaluate the correlation of demographic factors such as age, BMI, marital status, education, and working hours with non specific low back pain, to examine the impact of social factors such as family support, number of children, and nature of the work environment on the incidence of low back pain, to investigate the intensity of psychological stress and its association with non specific low back pain, to measure the effect of physical health status on the occurrence and severity of low back pain, to investigate pain intensity, and to measure the quality of life of home based female entrepreneurs with non specific low back pain. Hypothesis
Null Hypothesis H0
There is no significant association between non specific low back pain and demographic, social, psychological, physical, pain related or quality of life factors among home based female entrepreneurs. Alternate Hypothesis H1
There is a significant association between non specific low back pain and one or more of the following factors demographic characteristics, social background, psychological stress, physical health status, pain severity and quality of life among home based female entrepreneurs. |