| CTRI Number |
CTRI/2026/02/104585 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Instrument assisted soft tissue mobilization] |
| Study Design |
Other |
|
Public Title of Study
|
Study to check whether a special physiotherapy technique using instrument reduces heel pain and improves foot function in adults with Plantar Fasciitis |
|
Scientific Title of Study
|
Effects of Instrument Assisted Soft Tissue Manipulation on pain and foot function in subjects with Plantar Fasciitis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna Kokane |
| Designation |
PG student |
| Affiliation |
DY Patil Deemed to be University, School of Physiotherapy |
| Address |
DY Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,6th floor, Plot no.2, Sector-5, Nerul, Navi Mumbai
DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of physiotherapy, Msk lab 6th floor
Mumbai
MAHARASHTRA
400706
India
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9820038606 |
| Fax |
|
| Email |
prernagokul88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Riddhi Shroff |
| Designation |
Associate Professor |
| Affiliation |
DY Patil Deemed to be University, School of Physiotherapy |
| Address |
DY Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,6th floor, Plot no.2, Sector-5, Nerul, Navi Mumbai
DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of physiotherapy, Msk lab 6th floor
Mumbai
MAHARASHTRA
400706
India
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9769491687 |
| Fax |
|
| Email |
riddhi.shroff@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prerna Kokane |
| Designation |
PG Student |
| Affiliation |
DY Patil Deemed to be University, School of Physiotherapy |
| Address |
DY Patil Deemed to be University, School of Physiotherapy, Department of Musculoskeletal Physiotherapy,6th floor, Plot no.2, Sector-5,Nerul, Navi Mumbai
DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai School of physiotherapy, Msk lab 6th floor
Mumbai
MAHARASHTRA
400706
India
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9820038606 |
| Fax |
|
| Email |
prernagokul88@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, DY Patil University Navi Mumbai,400706, India |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy |
| Address |
DY Patil Deemed to be University Sector 7, Nerul, Navi Mumbai
School of physiotherapy, Msk lab 6th floor,400706, India |
| Type of Sponsor |
Private 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 |
| Prerna Kokane |
D.Y. Patil Hospital |
Department of Musculoskeletal Physiotherapy,OPD no.29,Plot no.2,sector-5,Nerul,Navi Mumabi-400706
Thane
Maharashtra
Mumbai
MAHARASHTRA |
9820038606
prernagokul88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insticutional cunics Committee (IEC) For Biomedical and Health Research |
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 |
Instrument assisted soft tissue mobilization along with evidence exercise |
3 Sessions for one week Instrument Assisted soft tissue mobilization application method: Using the Edge mobility tool, each participant will be received 10 minutes of IASTM. The Edge Mobility Tool will be used to mobilize the tissues on the triceps surae and plantar area of the foot by exerting constant pressure down the leg and foot after applying lubricant/gel to the calf and plantar region of the foot to assist decrease friction on the skin. The device will be moved parallel to fibers in alternating proximal and distal directions. Evidence based exercise: Stretching exercise - Plantar fascia – pt will be in long sitting and calcaneus fixed and metatarsal head will be passively dorsiflexed, Gastrocnemius- knee extended and ankle will be dorsiflexed Soleus – knee flexed and ankle will be dorsiflexed Duration- 30 sec for 3times,10 sec rest . Short foot exercises: Participants will be instructed to sit on an adjustable chair, placing their hips, knees, and ankles at 90 degrees. A towel will be placed under the foot, and participants will be instructed to pull and hold for 5 seconds the first metatarsal head toward the heel while avoiding bending their toes,10 reps with 3set with 1min rest btw set. And after that Lifting pebbles with the toes for 10 repetitions 3 sets. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
To be included in the study the subject needed to fulfill two or more of the following inclusion criteria
•Both male and female participants age between 18 and 60 years
•Plantar medial heel pain most noticeable with initial steps after a period of inactivity, but also worse following prolonged weightbearing
•Heel pain precipitated by a recent increase in weightbearing activity
•Pain with palpation of the proximal insertion of the plantar fascia
•Positive windlass test it is positive if there is pain at the heel area when the toes are passively dorsiflexed.
|
|
| ExclusionCriteria |
| Details |
•Diabetic neuropathy
•Patients with congenital foot abnormalities, tumor
• Patients who have had a lower limb fracture or surgery before 6 months.
•Patients who have a history of any soft tissue injury around ankles in last 6 months.
•Patients who have refused to take part in the study
•Subjects with clinical disorders such as infective conditions of foot, tumor, calcaneal fracture, metal implant where instrument-assisted soft tissue mobilization is contraindicated.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Pressure Threshold |
Baseline and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot Function Index Scale |
Baseline and after 1 week |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
07/03/2026 |
| 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="0"
Months="8"
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
|
The Study aims to evaluate the immediate effect of Instrument Assisted soft tissue mobilization (IASTM) along with evidence based exercise on Pain and Foot Function in patients with plantar Fasciitis, a sample size of 35 participants will be taken.
Group will receive IASTM for ( 10 minutes) with evidence based exercise. They will receive Three Supervised treatment sessions for one week of two days of gap in between . And Four unsupervised treatment sessions in which participants will actively perform the exercise at home. Outcomes will be taken at the beginning (Day 1) and of the end ( Day 7).
Windlass test will be used for Plantar Fasciitis , Pain Pressure Threshold will be used for pain and the Foot Function Index Scale will be used for foot functional disability as outcome measures. |