| CTRI Number |
CTRI/2025/11/097656 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two pain mitigation strategies of a minimally invasive surgical technique in patients suffering from plantar fasciitis, which is refractory to medical management |
|
Scientific Title of Study
|
Comparison of super selective transcatheter arterial embolization versus non-selective ultrasound guided embolization technique in plantar fascitis refractory to conservative management: an open-label pilot randomised 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 |
Akshit Kumar |
| Designation |
Senior resident |
| Affiliation |
All India Institue of Medical Sciences (AIIMS) New Delhi |
| Address |
Room number 10A, Department of Cardiovascular Radiology and Endovascular Interventions, CN Centre, AIIMS, Ansari Nagar, New Delhi, 110029
South DELHI 110029 India |
| Phone |
07051870260 |
| Fax |
|
| Email |
aks00712@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priya Jagia |
| Designation |
Head and professor |
| Affiliation |
AIl India Institite of Medical Sciences (AIIMS), New Delhi |
| Address |
Department of cardiovascular radiology and endovascular interventions, CN centre, AIIMS, Ansari nagar, New Delhi
South DELHI 110029 India |
| Phone |
09868114037 |
| Fax |
|
| Email |
drpjagia@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Priya Jagia |
| Designation |
Head and professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) New Delhi |
| Address |
Department of cardiovascular radiology and endovascular interventions, CN Centre, AIIMS, New Delhi
South DELHI 110049 India |
| Phone |
09868114037 |
| Fax |
|
| Email |
drpjagia@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of cardiovascular radiology and endovascular interventions |
| Type of Sponsor |
Other [Other] |
|
|
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 Priya Jagia |
AIIMS New Delhi |
Department of cardiovascular radiology and endovascular interventions South DELHI |
09868114037
drpjagia@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M70||Soft tissue disorders related to use, overuse and pressure, (2) ICD-10 Condition: M722||Plantar fascial fibromatosis, (3) ICD-10 Condition: Z48||Encounter for other postproceduralaftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non selective USG (Ultrasound) guided embolization technique in plantar fascitis. |
Drug-Imipenem-cilastatin sodium,
Dose- Single injection (500 mg reconsituted in 7 cc saline),
Mode- Intra-arterial via posterior tibial artery, Non selectively using Ultrasound guided puncture |
| Comparator Agent |
Super-selective embolization technique in plantar fascitis |
Drug-Imipenem-cilastatin sodium
Dose- Single injection (500 mg reconsituted in 7 cc saline) Mode- Intra-arterial via super-selective cannulation of branches of posterior tibial artery supplying the plantar fascia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
A patient with
1. Tenderness at the calcaneal attachment
2. Thickened plantar fascia (more than 4 mm) on preprocedural MRI.
3. No meaningful improvement with more than 3 months of conservative treatment (rest, anti-inflammatory
drugs, and physical therapy)
|
|
| ExclusionCriteria |
| Details |
1. Uncorrectable coagulopathy as defined by INR more than 2.5 or platelet count less than 30,000
2. Iodine allergy resulting in anaphylaxis
3. Renal dysfunction as defined by eGFR of less than 30
4. Currently pregnant
5. Previous foot surgery
6. Not giving consent for the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Technical success, Post procedural pain relief |
24 hours, 7 days, 1 month, 3 month, 6 month, 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of multiple reinterventions, Complications |
24 hours, 7 days, 1 month, 3 month, 6 month, 12 month |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
15/12/2025 |
| 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="3" 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
|
Super-selective
transcatheter arterial embolisation (TAE) is being established as a standard
procedure in the pain management of musculoskeletal inflammatory conditions,
particularly in patients who are refractory to conservative management. These
conditions include knee osteoarthritis, frozen shoulder, and Achilles
tendinopathy. The mechanism involves abnormal neo-vessel occlusion resulting from inflammation, leading to decreased inflammation.
However, evidence for TAE in
plantar fascitis is limited to small observational studies and case reports.
These studies describe two approaches: standard super-selective embolization
and non-selective ultrasound-guided (USG) embolization, the latter involving
the injection of a temporary embolic agent (imipenem/cilastatin) into the
posterior tibial artery. Each method has distinct advantages and drawbacks. Super-selective
embolization offers greater safety but is time-intensive and involves radiation
exposure for both the patient and the operator. Conversely, non-selective
USG-guided embolization requires fewer resources, such as microcatheters and
digital subtraction angiography (DSA) equipment, but carries a minor
theoretical risk of inadvertent embolization. The comparative efficacy of these
techniques for pain relief in plantar fascitis remains inadequately explored
due to a lack of robust comparative data.
This
study is therefore designed to study the feasibility and compare the clinical
outcomes of patients treated with super selective TAE versus Non-selective USG-guided
embolization technique. |