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CTRI Number  CTRI/2025/01/078926 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effectiveness of Stretching Exercises and Corticosteroid Injections for management of Plantar Fasciitis: A Randomized controlled trial. 
Scientific Title of Study   Planter fascia stretching exercises versus ultrasound guided local corticosteroid injection for planter fasciitis: A randomized controlled trial. 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neelam Kumari 
Designation  Junior Resident 
Affiliation  PMR Department, KGMU, LKO 
Address  Department of PMR, King George’s Medical University, Lucknow

Lucknow
UTTAR PRADESH
226005
India 
Phone  6392714268  
Fax    
Email  dr.neelampjt123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dileep Kumar 
Designation  Professor 
Affiliation  PMR Department, KGMU, LKO 
Address  Department of PMR, King George’s Medical University, Lucknow

Lucknow
UTTAR PRADESH
226018
India 
Phone  7007636236  
Fax    
Email  dileepmsortho@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Neelam Kumari 
Designation  Junior Resident 
Affiliation  PMR Department, KGMU, LKO 
Address  Department of PMR, King George’s Medical University, Lucknow

Lucknow
UTTAR PRADESH
226005
India 
Phone  6392714268  
Fax    
Email  dr.neelampjt123@gmail.com  
 
Source of Monetary or Material Support  
Department of PMR, King George Medical University, Lucknow, 226003, India 
 
Primary Sponsor  
Name  Neelam Kumari 
Address  Junior Resident, Department of PMR, King George’s Medical University, Lucknow 
Type of Sponsor  Other [SELF] 
 
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 Neelam Kumari  King George’s Medical University  Department of PMR, King George’s Medical University, Lucknow
Lucknow
UTTAR PRADESH 		 6392714268

dr.neelam123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George Medical University U.P., Institutional Ethics Committee, Lucknow-226003 (UP) India  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 
Comparator Agent  Plantar Fascia Stretching Exercises  Initially pain will be assessed before starting Plantar Fascia stretching exercises by using NPRS. Plantar Fascia and Tendo-Achilles Stretching Exercises, performed thrice daily and 20 repetition for each exercises. Patients will be followed up at 4th, 8th and 12th week and pain assessment done by using NPRS. 
Intervention  Ultrasound-Guided Local Corticosteroid Injection  Initially pain will be assesed at pre-intervention by using NPRS. Under USG guidance a single dose of corticosteroid injection 1ml of 40 mg methylprednisolone acetate with 1 ml of 2% lignocaine local injected above plantar fascia. Patients will be followed up at 4th, 8th and 12th week and pain assessment done by using NPRS.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Pain duration of 0-3 months
Patient with heel pain with a confermed clinical diagnosis of plantar fasciitis
Patient giving consent to participate in this study
 
 
ExclusionCriteria 
Details  BL heel pain with systemic disease like rheumatoid arthritis, ankylosing spondylitis and Reiter disease.
Previous surgery involving heel
Previous history of calnaeum fracture
Infection/ abscess around heel
Uncontrolled Diabetes mellitus
Gouty arthritis open wound over heel
Osteomyelitis of calcaneum
Entrapment neuropathy 
Malignancy 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain measured by a standardized scale such as the Numeric Pain Rating Scale (NPRS).  Numeric Pain Rating Scale (NPRS) will be done at baseline, 4th, 8th and 12th week time intervals.  
 
Secondary Outcome  
Outcome  TimePoints 
Functional Improvement: Evaluated using tools like the Foot Function Index (FFI)  4 weeks, 8 weeks, and 12 weeks  
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   28/01/2025 
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="1"
Months="6"
Days="0" 
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   This randomized controlled study compares the effectiveness of Plantar Fascia Stretching Exercises and Ultrasound-Guided Corticosteroid Injections in relieving pain and improving function in patients with plantar fasciitis. It evaluates outcomes like pain reduction, functional improvement, and potential adverse effects of both interventions 
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