| CTRI Number |
CTRI/2025/07/090699 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the effects of two different injection treatments to find out which one is more effective in reducing heel pain and improving walking ability in people suffering from plantar fasciitis |
|
Scientific Title of Study
|
Biomechanical Effects OF Ultrasound-Guided Prolotherapy Versus Corticosteroid Injection In Unilateral Plantar Fasciitis: A Double-Blinded Randomised Controlled Academic 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 |
Shoibam Jenifa Devi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) Mangalagiri, Andhra Pradesh |
| Address |
Room no. 137, Department of Physical Medicine and Rehabilitation, AIIMS Mangalagiri, Guntur-522503, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7005839513 |
| Fax |
|
| Email |
shoibam60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shoibam Jenifa Devi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) Mangalagiri, Andhra Pradesh |
| Address |
Room no. 137, Department of Physical Medicine and Rehabilitation, AIIMS Mangalagiri, Guntur-522503, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7005839513 |
| Fax |
|
| Email |
shoibam60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Banoth Kiran Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) Mangalagiri, Andhra Pradesh |
| Address |
Room no. 138, Department of Physical Medicine and Rehabilitation, AIIMS Mangalagiri, Guntur-522503, Andhra Pradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9560816404 |
| Fax |
|
| Email |
drkiran.pmr@aiimsmangalagiri.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shoibam Jenifa Devi |
| Address |
Room no. 137, Department of Physical Medicine and Rehabilitation, AIIMS Mangalagiri, Guntur-522503, Andhra Pradesh |
| Type of Sponsor |
Other [Self ] |
|
|
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 Shoibam Jenifa Devi |
AIIMS Mangalagiri, Andhra Pradesh |
Room no. 140, Department of Physical Medicine and Rehabilitation
Guntur
ANDHRA PRADESH |
7005839513
shoibam60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound (USG) guided
dextrose prolotherapy (DPT) |
Injection of 2 ml of 25% Dextrose into the diseased plantar fascia under USG guidance, only once at the start of the study.
|
| Comparator Agent |
Ultrasound (USG) guided corticosteroid injection (CSI) |
Injection of 1 ml Methylprednisolone plus 1 ml of Lignocaine 2% into the diseased plantar fascia under ultrasound guidance, only once at the start of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
U/L Plantar Fasciitis patients diagnosed through clinical history and examination for more than 3 months, who have not responded to conservative management for 4 weeks and have consented to participate in the study |
|
| ExclusionCriteria |
| Details |
Age under 18 years, has had a steroid injection in the last 6 months; wound, infection, tumour, or injury over the heel; presence of neuropathy or radicular pain; having a bleeding disorder; systemic inflammatory rheumatic diseases; local or systemic neurological disorders; knee or ankle joint dysfunction; limb length discrepancy greater than 1 cm; history of foot surgery or fracture; pregnant or lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kinetic parameters:
Maximum force at the forefoot, midfoot, and hindfoot
Maximum pressure of each foot
Foot rotation angle of each foot
COP (Center of Pressure) - Degree of Rotation
|
0, 4, and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Step parameters: step length, step time, stride length, stride time, cadence
Gait cycle parameters: heel contact, loading response, single limb support, pre-swing, and double support
Contact-time parameters: rearfoot, midfoot, and forefoot
|
0, 4, and 12 weeks |
| Plantar Fascia thickness |
0, 4, and 12 weeks |
| Pain score ; VAS: on a scale of 0-10 |
0, 4, and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2025 |
| 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 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 study compares the effectiveness of ultrasound-guided corticosteroid injections (USG-CSI) and dextrose prolotherapy (DPT) in treating chronic plantar fasciitis. In addition to assessing pain relief and functional improvement, the study examines how each therapy affects foot biomechanics, including weight distribution and gait patterns. By analyzing these biomechanical changes, the research aims to determine which treatment offers better long-term outcomes in symptom management and the restoration of normal walking function. |