| CTRI Number |
CTRI/2024/08/072746 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| 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
|
To See The Effectiveness Of Muscle Energy Technique Versus Instrument Assisted Soft Tissue Mobilization On Pain And Range Of Motion In Patients With Plantar Fasciitis A Comparative Study |
|
Scientific Title of Study
|
Effectiveness Of Muscle Energy Technique Versus Instrument Assisted Soft Tissue Mobilization On Pain And Rom In Subjects With Plantar Fasciitis A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Patil |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Department - Parul Sevashram Hospital
Division - Orthopedic Physiotherapy Opd
Room No 210
Vadodara GUJARAT 391760 India |
| Phone |
9307810642 |
| Fax |
391760 |
| Email |
drpoojap8898@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pooja Patil |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Department - Parul Sevashram Hospital
Division - Orthopedic Physiotherapy Opd
Room No 210
GUJARAT 391760 India |
| Phone |
9307810642 |
| Fax |
391760 |
| Email |
drpoojap8898@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dwija Yagnik |
| Designation |
Assistant professor |
| Affiliation |
Parul University |
| Address |
Department - Parul Sevashram Hospital
Division - Orthopedic Physiotherapy Opd
Room No 210
Vadodara GUJARAT 391760 India |
| Phone |
9909021553 |
| Fax |
391760 |
| Email |
dwija2988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University, Parul Sevashram Hospital,Post Limda,Waghodia,Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Dwija Yagnik |
Parul University |
Parul University Post limbda waghodia vadodara Gujarat 391760
Physiotherapy department,physio ortho opd room no 210 Vadodara GUJARAT |
9909021553 391760 dwija2988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul university (IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IASTM |
Total Protocol 4 weeks(3 seesion per week) duration 40 min
50 strokes |
| Intervention |
Muscle Energy Technique |
Total Protocol 4weeks (3 session per week) Duration 35 min
3 repetations |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient diagnosis with plantar fasciitis by orthopedic.
2)Both male and female included.
3)Positive windlass test
4)Age 40 to 60 years
5)Patient having history of heel pain for 4 week
6)Patient with complain of pain with first step 7)after out of bed in morning
8)Patient which not participated for any other study
9)Patient who understand Hindi Gujrati English
|
|
| ExclusionCriteria |
| Details |
1)Any history of recent ankle and foot fracture
2)Previous history of foot surgery
3)Burns at foot
4)Patients having heel spur
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range Of Motion |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale for Assesing Pain |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="63" Sample Size from India="63"
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)
|
30/08/2024 |
| 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 Yet Recruiting |
| 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
|
AIM : The aim of this study is to compare the effect of MET and IASTM on
pain and Rom in persons with plantar
fasciitis.
INTRODUCTION: Plantar
fasciitis is degenerative foot
condition or common foot problem that affects individuals universally, irrespective the Age, Gender ,or
activity level.(1)Plantar fascia is a thick band of tissue at the bottom foot
which connects the heel bone to your toes. and also provide support to arch of the foot and act like shock
absorber during activities like walking ,running. Inflammation of plantar
fascia most commonly leads to plantar
fasciitis .Plantar fasciitis is common cause of foot pain ,which basically
result from repetitive micro trauma or
excessive load to the fascia,
NEED OF STUDY : Plantar fasciitis is common foot condition that affect the people
universally ,irrespective of their gender ,age or activities level, which
characterized by sharp ,stabbing pain in posteromedial area of heel ,pain may
increases with prolonged standing. Both active young individuals and older
adults may suffer from plantar heel
pain, which affect the quality of life. Recent study says that ,out of 10
individuals one may affect with plantar fasciitis at some point of there life
span. MET and IASTM both technique used as part of manual therapy, there is no
study done yet to compare that which
technique is more effective in treatment of plantar fasciitis ,hence study is
needed to feel the gap. Procedure - After taking approval from ctri and ethical commitee inform consent will be taken from the patients and pre assessment will be done according to conclusion criteria .Participants will be divided into two equal groups in Group A will Receive MET for 4 weeks and Group B will receive IASTM 4 Weeks and post assessment will be taken after for weeks . Conclusion pf the study will be made after statistical analysis. |