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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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