| CTRI Number |
CTRI/2026/02/104613 [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
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparison of two physiotherapy treatments for Heel Pain Relief" |
|
Scientific Title of Study
|
Efficacy of Instrument Assisted Soft Tissue Mobilization (IASTM) Versus High Intensity Laser Therapy (HILT) on Pain, Foot functions and Activity Limitations in patients 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 |
Dr Bhagya Laxmi Uikey PT |
| Designation |
Student (Pursuing MPT in Musculoskeletal Physiotherapy) |
| Affiliation |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) |
| Address |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan),4 Vishnu Digamber Marg New Delhi,Delhi-110002
Central DELHI 110002 India |
| Phone |
7389023055 |
| Fax |
|
| Email |
uikeybhagya98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Ramprabhu PT |
| Designation |
Assistant professor (PT) (MPT- Orthopedic) |
| Affiliation |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) |
| Address |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan),4 Vishnu Digamber Marg New Delhi,Delhi-110002
Central DELHI 110002 India |
| Phone |
9818885324 |
| Fax |
|
| Email |
ramp76@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Ramprabhu PT |
| Designation |
Assistant professor (PT) (MPT- Orthopedic) |
| Affiliation |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) |
| Address |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan),4 Vishnu Digamber Marg New Delhi,Delhi-110002
Central DELHI 110002 India |
| Phone |
9818885324 |
| Fax |
|
| Email |
ramp76@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) 4 Vishnu Digamber New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Rehabilitation and Academic Institute] |
|
|
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 Bhagya Laxmi Uikey PT |
Pandit. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) |
Department of Physiotherapy, Room no. 21, 4 Vishnu Digamber Marg New Delhi,Delhi-110002 Central DELHI |
7389023055
uikeybhagya98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committie Pt. Deendayal Upadhyaya National Institute for Person with Physical Disabilities (Divyangjan) |
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 |
| Comparator Agent |
High Intensity Laser Therapy (HILT) along with standardized exercise program |
High Intensity Laser Therapy (HILT) will be given for a total nine treatment sessions over a period of 3 consecutive weeks and standardized exercise program followed for 4 weeks. |
| Intervention |
Instrument Assisted Soft Tissue Mobilization (IASTM) along with standardized exercise program
|
IASTM will be given for 10 minutes for total eight treatment sessions for 2 days in a week for 4 weeks and standardized exercise program followed for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Age-range: 25-45 years.
2) Both males or females.
3) Patient with painful tender heel.
4) Pain that worsened in the morning and after prolonged standing or walking.
5) NPRS score of more than or equal to 4.
6) Exacerbation of local pain on plantar fascia stretch around medial tubercle of calcaneum.
|
|
| ExclusionCriteria |
| Details |
1) Systematic inflammatory diseases.
2) Previous fracture or surgery of the foot.
3) Rheumatoid arthritis.
4) Diabetes mellitus.
5) Osteoporosis.
6) Cancer, infectious disease and tumor.
7) Calcaneal spur showing on radiological finding will be excluded.
8) Patient with Navicular drop of 10mm or more will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot and Ankle Ability Measure (FAAM) for Activity of daily living |
Pre & post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale (NPRS) for Pain and Foot Function Index (FFI) for foot functions.
|
Pre & post intervention. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
09/03/2026 |
| 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="6" 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 is a randomised clinical trial, subjects with plantar fasciitis will be screened based on inclusion and exclusion criteria. Those who meet the criteria will be enrolled after completing clinical assessment, demographic data recording, and obtaining informed consent. A total of 40 subjects will be randomly divided into two groups of 20 each. One group will receive Instrument Assisted Soft Tissue Mobilization (IASTM) along with standardized exercises, while the other group will receive High Intensity Laser Therapy (HILT) with the same exercise program. The intervention will be carried out for 4 weeks. Study parameters will be assessed at baseline and again after 4 weeks to compare pre- and post-treatment outcomes. |