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
|
|
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
|
|
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. |