| 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
|
|
|
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
|
|
|
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. |