| CTRI Number |
CTRI/2024/03/063417 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
TREATMENT OF PLANTAR FASCITIS USING PLATELET RICH PLASMA INJECTION AND PHYSIOTHERAPY VS ONLY PHYSIOTHERAPY AND FINDING THE BETTER OUTCOME AMONG THEM |
|
Scientific Title of Study
|
EFFICACY OF PLATELET RICH PLASMA INJECTION AS AN COMBINED MODALITY IN REDUCING PAIN AND IMPROVING FUNCTIONAL OUTCOME IN PLANTAR FASCIITIS - A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AVINASH G |
| Designation |
POST GRADUATE |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ORTHOPAEDICS, GROUND FLOOR OPD BLOCK, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES , GANAPATHICHETIKULAM, PUDUCHERRY
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7871718103 |
| Fax |
|
| Email |
nashavi13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRINCE SOLOMON |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ORTHOPAEDICS, GROUND FLOOR OPD BLOCK, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES , GANAPATHICHETIKULAM, PUDUCHERRY
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9489390335 |
| Fax |
|
| Email |
princesolomon_80@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AVINASH G |
| Designation |
POST GRADUATE |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ORTHOPAEDICS, GROUND FLOOR OPD BLOCK, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES , GANAPATHICHETIKULAM, PUDUCHERRY
PONDICHERRY
605014
India |
| Phone |
7871718103 |
| Fax |
|
| Email |
nashavi13@gmail.com |
|
|
Source of Monetary or Material Support
|
| PONDICHERRY INSTITUTE OF MEDIAL SCIENCES, PONDICHERRY |
|
|
Primary Sponsor
|
| Name |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, GANAPATHICHETKULAM, PUDUCHERRY-605014 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR AVINASH |
39,othavadai street,orleanpet,puducherry |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AVINASH G |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ORTHOPAEDICS, PONDICHERRY INSTITUTE OF MEDICAL SCIENCES
Pondicherry
PONDICHERRY |
7871718103
nashavi13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (2ml of normal saline) injection |
Patients in group B would be receiving Single 2ml of normal saline(placebo) injection on foot in the medial plantar heel region/maximum point of tenderness under sterile precaution ,ultrasound therapy for 4 weeks and exercises would be demonstrated which should be done one session per day for 12weeks |
| Intervention |
PLATELET RICH PLASMA INJECTION |
Patients in group A would be receiving Single 2ml of Platelet-rich plasma local injection on foot in the medial plantar heel region/maximum point of tenderness under sterile precaution ,ultrasound therapy for 4 weeks and exercises would be demonstrated which should be done one session per day for 12weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.)Patients aged between 18 to 60 years.
2.)Patients having complaints of heel pain for more than 3 months.
3.)Tenderness on palpation at the proximal insertion of the plantar fascia.
4.) Patients with positive windlass test.
5.) Ultrasound plantar fascia thickness of more than 4mm. |
|
| ExclusionCriteria |
| Details |
1.)Congenital defects of the foot
2.)Previous surgery of the foot.
3.)Patient with a History of Trauma to the heel.
4.)Pregnancy
5.)Patient on Anti-coagulant therapy
6.)Patient with the Bleeding disorder.
7.)Presence of any Local infection.
8.)History of Rheumatoid arthritis.
9.)History of Peripheral Vascular disease.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plantra dasciitis pain scale
foot and ankle ability measure scale
ultrasound plantar fascia thickness |
PFPS AND FAAM SCORE AT BASELINE,2 WEEKS ,4WEEKS,8 WEEKS AND 12 WEEKS
USG PLANTAR FASCIA THICKNESS AT BASELINE AND 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ultrasound plantar fascia thickness |
ultrasound plantar fascia thickness at 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
successful treatment of plantar fasciitis usually requires a combination of treatment modalities, rather than administering only one treatment at a time there were no studies showing the efficacy of platelet-rich plasma as a safe and effective therapeutic adjuvant. we would be using three parameters to assess the disease by radiological and functional outcomes in PFPS, FAAM, and ultrasonogram of the plantar fascia. Hence our study aimed at proving the efficacy of PRP as a combined modality treatment of plantar fasciitis. We hypothesize that Platelet-rich plasma local injection given along with standard conventional treatment reduces pain and improves functional outcomes better than standard conventional treatment alone among patients with plantar fasciitis |