| CTRI Number |
CTRI/2024/03/064410 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Heel pain among street fruit sellers |
|
Scientific Title of Study
|
Prevalence of Chronic Heel pain and associated risk factors on quality of life among street vendors in Delhi- 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 |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B319, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B319, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
UTTAR PRADESH 203201 India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Astha |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No 00E, Department of Physiotherapy, School of Allied Health Sciences, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida NIL Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
8178522449 |
| Fax |
|
| Email |
aastha.20smas1010067@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida Uttar Pradesh India, 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room No C 201,Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Sidiq |
Galgotias University |
Room No E003,
Department of
Physiotherapy, Galgotias University
Gautam Buddha Nagar UTTAR PRADESH |
6006204628
sidufatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Street vendors engaged in various occupations such as selling goods, food, or services in public spaces.
2.Individual with chronic heel pain (more than 3 months)
3. Individual who have standing work for more than 10 hours
4.Participants willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1. Individuals below the age of 18 or above 65 years.
2. Those without chronic heel pain.
3. Individuals who are not street vendors.
4. Participants unwilling or unable to provide informed consent.
5. Individuals with a history of significant musculoskeletal or neurological disorders affecting the lower limbs.
6. Pregnant women, as pregnancy-related physiological changes may impact the prevalence and characteristics of heel pain.
7. Individuals with cognitive impairments that hinder their ability to participate in the study.
8. Those currently undergoing treatment or surgery for heel pain or related conditions.
9. Participants with a history of trauma or surgery to the lower limbs in the past six months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS SCALE
FOOT FUNCTION INDEX
%AGE ESTIMATION OF PREVALENCE |
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="363" Sample Size from India="363"
Final Enrollment numbers achieved (Total)= "336"
Final Enrollment numbers achieved (India)="363" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2024 |
| Date of Study Completion (India) |
01/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Introduction: Chronic heel pain is a prevalent symptom, particularly among older adults, impacting mobility and daily activities. This cross-sectional study aims to investigate the prevalence of chronic posterior heel pain and its associated risk factors among street vendors in Delhi, shedding light on a population not extensively studied before. While previous research has focused on Western societies, this study recognizes the need to understand foot health in Asian populations, considering cultural and lifestyle differences.
Objective: The primary objectives are to estimate the prevalence of heel pain among street vendors, identify associated risk factors, and evaluate the impact of posterior heel pain on their quality of life.
Literature Review: Existing studies highlight the prevalence of posterior heel pain in various populations, with factors such as obesity, manual occupations, and physical inactivity contributing to its occurrence. This study aims to contribute valuable insights into the prevalence and impact of heel pain specifically among street vendors in Delhi.
Methods: The study will employ an observational cross-sectional design, collecting data from street vendors through surveys and physical examinations. Ethical approval will be obtained, and informed consent will be secured from each participant. Outcome measures include the Foot Function Index (FFI) and SF36 for disability, pain, activity restriction, and quality of life assessment.
Discussion: By addressing the research gap in understanding foot health among street vendors, this study provides valuable information for healthcare professionals and policymakers. The findings can inform preventive measures and interventions tailored to this specific population.
Conclusion: This study aims to contribute novel insights into the prevalence, risk factors, and impact of chronic posterior heel pain among street vendors in Delhi, enhancing our understanding of foot health in diverse populations. |