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CTRI Number  CTRI/2025/05/087247 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Which Treatment Works Best for Chronic Heel Pain? Comparing PRP with Nerve Block, PRP Alone, and Steroid Injections 
Scientific Title of Study   Comparative Evaluation of Platelet-Rich Plasma Injections with Baxter’s Nerve Block vs Platelet-Rich Plasma Injections Alone vs Corticosteroid Injections in the Management of Chronic Plantar Fasciitis: A Pilot Randomized Controlled Trial 
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 Ajit Kumar 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  6th floor C wing Department of anaesthesiology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajit.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajit Kumar 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  6th floor C wing Department of anaesthesiology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajit.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ajit Kumar 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  6th floor C wing Department of anaesthesiology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249202
India 
Phone  9910789377  
Fax    
Email  ajit.anaes@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
All india institute of medical science , virbhadra road, rishikesh, dehradhun, India. Pincode 249202 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  6th floor C Wing department of anaesthesiology AIIMS Rishikesh 
Type of Sponsor  Government medical college 
 
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 Ajit Kumar  AIl India Institute of Medical Science  Division of Pain medicine,Department of anaesthesiology
Dehradun
UTTARANCHAL 
9910789377

ajit.anaes@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  corticosteroid injections  Procedure: Corticosteroid injections around plantar facia using dose 40 mg of depot methylprednisolone plus 1% lignocaine 2ml, frequency will be once and total duartion of procedure will be 15 minutes. 
Intervention  PRP injections   Procedure: Single injection of PRP into the affected heel. PRP Preparation: 8 mL of venous blood will be processed via centrifugation to isolate PRP. A 2-3 mL PRP solution will be injected into the plantar fascia under sterile conditions, using ultrasound guidance, frequency will be once and total duration of procedure will be 15 minutes.  
Intervention  PRP injections with Baxter’s nerve block.  Procedure: PRP injection as described above, followed by a nerve block targeting the inferior calcaneal nerve using dose 3 mL of lidocaine 1% under ultrasound guidance, frequency will be once and total duration of procedure will be 15 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age greater than or equal to 18 years, either sex.
2. Clinical diagnosis of plantar fasciitis for at least 3 months, plus ultrasound confirmed thickening of the plantar fascia ( greater than 4 mm at the insertion).
3. Pain score (NRS) greater than or equal 5/10 at baseline.
4. Failure of conservative treatments (NSAIDs, exercises, orthotics, etc.) for at least 6 weeks.
5. Willingness to provide written informed consent and comply with follow-up visits.
 
 
ExclusionCriteria 
Details  1. Previous foot or ankle surgery within the last 6 months.
2. Systemic diseases or conditions that may impair healing (e.g., uncontrolled
diabetes, significant peripheral vascular disease, rheumatoid arthritis,
autoimmune disorders).
3. Coagulopathies or ongoing use of anticoagulants that contraindicate
injection therapy.
4. Pregnant or breastfeeding women.
5. Neurological conditions affecting foot sensation (e.g., peripheral
neuropathy) or pain perception.
6. Any contraindication to local anesthetics or PRP (e.g., local infection,
severe anemia, platelet dysfunction). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in heel pain, measured using Numeric Rating Scale .
Plantar fascia thickness measurement using Ultrasound  
baseline, 6 weeks,and 12 weeks post-treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Improvement: Assessed through the Foot and Ankle Disability
Index (FADI) 
baseline, 6 weeks,and 12 weeks post-treatment. 
Patient Satisfaction: Measured through a patient satisfaction questionnaire  baseline, 6 weeks,and 12 weeks post-treatment. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   31/05/2025 
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="0"
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 single center prospective pilot randomized controlled trial investigates the comparative efficacy of three interventional modalities for the management of chronic plantar fasciitis: ultrasound guided platelet rich plasma PRP injections into the plantar fascia, PRP injections combined with ultrasound guided Baxters nerve block targeting the first branch of the lateral plantar nerve, and ultrasound guided corticosteroid methylprednisolone injections with lignocaine. A total of 45 adult patients aged 18 years and above with clinically diagnosed and ultrasonographically confirmed plantar fasciitis with fascia thickness greater than 4 mm refractory to conservative therapy will be randomized equally into three parallel groups. All participants will continue to receive standardized conservative management. The primary endpoints include changes in pain intensity measured using the Numeric Rating Scale NRS and plantar fascia thickness assessed via high resolution ultrasonography at baseline, 6 weeks, and 12 weeks. Secondary endpoints include functional outcomes assessed by the Foot and Ankle Disability Index FADI, patient satisfaction measured via a structured questionnaire at 12 weeks, and documentation of any adverse events. Statistical analysis will involve repeated measures ANOVA, t tests, or nonparametric equivalents with significance set at p less than 005. The primary aim is to determine whether combining Baxters nerve block with PRP provides superior analgesic and functional benefits compared to PRP alone or corticosteroid injections.

 
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