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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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