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CTRI Number  CTRI/2025/02/080080 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding Factors That Cause Heel Pain: A Complete Study to Improve Treatment 
Scientific Title of Study   Influence of Biomechanical Factors on Plantar Heel Pain: A Comprehensive Analysis for an effective Management 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aravindhan K 
Designation  Postgraduate Student  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (deemed to be university), No.1 Ramachandra Nagar Porur, Chennai

Kancheepuram
TAMIL NADU
600116
India 
Phone  8124122945  
Fax    
Email  aravindhan836@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hepzibah Rubella D  
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra Nagar Porur Chennai

Kancheepuram
TAMIL NADU
600116
India 
Phone  9600009396  
Fax    
Email  hepzibahd@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Hepzibah Rubella D  
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra nagar Porur Chennai

Kancheepuram
TAMIL NADU
600116
India 
Phone  9600009396  
Fax    
Email  hepzibahd@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra nagar Porur Chennai 600116 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
Aravindhan k   sri ramachandra faculty of physiotherapy sri ramachandra institute of higher education and research   Physical Rehabilitation Department, Ground Floor New Block OPD Faculty of physiotherapy Sri Ramachandra Institute of Higher Education and Research(Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai- 600116
Kancheepuram
TAMIL NADU 
81241 22945

aravindhan836@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Institute of Higher Education And Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed with plantar heel pain
Plantar Heel pain in first step after awake up
 
 
ExclusionCriteria 
Details  Patients with a history of foot surgery or trauma
Ankle and foot fracture
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ankle range of motion, BMI, 1st mtp rom, calf muscle strength   Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
foot posture index-6, foot function index, plantar pressure  Baseline  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This cross-sectional study evaluates the biomechanical factors influencing plantar heel pain. After obtaining informed consent, participants undergo a detailed assessment, including foot posture analysis using the Foot Posture Index (FPI-6) and range of motion (ROM) measurements for ankle dorsiflexion and first metatarsophalangeal (MTP) joint mobility using a goniometer. BMI is calculated based on height and weight. Muscle strength is assessed through manual muscle testing of the ankle dorsiflexors, plantarflexors, evertors, and invertors, while gastrocnemius tightness is evaluated using the weight-bearing lunge test with an inclinometer. Foot alignment is analyzed through FPI-6, which examines talar head palpation, malleolar curvature, calcaneal position, medial longitudinal arch height, and forefoot alignment. Pain intensity is measured using the Visual Analog Scale (VAS), and functional impairment is assessed with the Foot Function Index (FFI), a 23-item questionnaire covering pain, disability, and activity limitations. Exclusion criteria include individuals with a history of ankle or foot fractures, prior foot surgery or trauma, ligament injuries, or vascular conditions. Patients with systemic diseases affecting the feet, such as autoimmune disease or rheumatoid arthritis, are also excluded to ensure a homogenous study population.

 
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