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CTRI Number  CTRI/2024/07/070672 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Immediate Effect Of Muscle Release Versus Strain Counter Strain On Pain In ITB Syndrome Among Treadmill Runners 
Scientific Title of Study   Immediate Effect Of Myofascial Release Versus Positional Release Technique On Pain In Iliotibial band Syndrome Among Treadmill Runners 
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 Chaitali neve 
Designation  Assistant Professor 
Affiliation  Dr.Ulhas Patil College Of Physiotherapy 
Address  NH 06 Gat No 57 2 Khirdi Shivar Tal And Dist Jalgaon Musculoskeletal Department Division A Room no 201 MAHARASHTRA 425309 India

Jalgaon
MAHARASHTRA
425309
India 
Phone  9518719182  
Fax    
Email  chaitalisneve123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaitali neve 
Designation  Assistant Professor 
Affiliation  Dr.Ulhas Patil College Of Physiotherapy 
Address  NH 06 Gat No 57 2 Khirdi Shivar Tal And Dist Jalgaon Musculoskeletal Department Division A Room no 201 MAHARASHTRA 425309 India

Jalgaon
MAHARASHTRA
425309
India 
Phone  9518719182  
Fax    
Email  chaitalisneve123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chaitali neve 
Designation  Assistant Professor 
Affiliation  Dr.Ulhas Patil College Of Physiotherapy 
Address  NH 06 Gat No 57 2 Khirdi Shivar Tal And Dist Jalgaon Musculoskeletal Department Division A Room no 201 MAHARASHTRA 425309 India

Jalgaon
MAHARASHTRA
425309
India 
Phone  9518719182  
Fax    
Email  chaitalisneve123@gmail.com  
 
Source of Monetary or Material Support  
Dr.Ulhas Patil College Of Physiotherapy 
 
Primary Sponsor  
Name  Mohammad Kaif Shah 
Address  NH 06 Gat No 57 2 Khirdi Shivar Tal And Dist Jalgaon MAHARASHTRA 425309 India 
Type of Sponsor  Other [Self] 
 
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 
DrChaitali Neve  Dr.Ulhas Patil College Of physiotherapy  NH 06 Gat No 57 2 Khirdi Shivar Tal And Dist Jalgaon Musculoskeletal Department Division A Room no 201 MAHARASHTRA 425309 India
Jalgaon
MAHARASHTRA 
9518719182

chaitalisneve123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr.Ulhas Patil College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Myofascial Release Technique  Maintain a steady pressure and adjust as needed to address areas of tension or tenderness,encourage the subject breath deeply through out the procedure,repeat this procedure for 6 minutes.after myofascial release was done apply icing to that area for 10 minutes. 
Comparator Agent  Positional Release Technique  grasps the patients leg and produces marked hip abduction and slight hip flexion with internal or external rotation to fine-tune the position Maintain this postion for 90 second this procedure repeated 3 times 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  Male individual 18-35
Ober test positive
Treadmill runner.
Regular treadmill runners since 3 months.
History of pain at lateral aspect of knee.

 
 
ExclusionCriteria 
Details  History of autoimmune disease
Any neurological disease disorder that impairs lower extremity function e.g. spasticity and or sensation.
Presence of skin lesions or skin rash on the involved lower extremity.
4.Recent injury at lower exterimity.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical pain rating scale(NPRS)
 
Pre and Post intervention(immediate after interevention)
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   25/07/2024 
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="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   AIMTo study the immediate effect of myofascial release versus positional release technique on pain in iliotibial band syndrome among treadmill runner’s.

 
OBJECTIVE-
1.To find out the effectiveness of myofacial release technique on pain in iliotibial band syndrome among treadmill runners.

2.To find out the effectiveness of positional release technique on pain in iliotibial band syndrome among treadmill runners.

3.To compare the effectiveness of myofascial release versus positional release technique on pain in iliotibial band syndrome among treadmill runners.


HYPOTHESIS [H]:

1.    There will be significant effectiveness of myofacial release technique on pain in iliotibial band syndrome among treadmill runners

2.    There will be significant effectiveness of positional release technique on pain in iliotibial band syndrome among treadmill runners.

                             

NULL HYPOTHESIS[H0]:

1. There will be no significant effectiveness of myofacial release technique on pain in iliotibial band syndrome among treadmill runners

2. There will be no significant effectiveness of positional release technique on pain in iliotibial band syndrome among treadmill runners.


PROCEDURE

To conduct the study Permission from Institutional ethical committee was taken. Subjects was selected according to the inclusion and exclusion criteria by Simple random sampling into two group by using lottery method. Procedure was thoroughly explained to the subjects selected for the study. A written informed consent was obtained from all participants who were willing to participate in the study.Then subjects was divided in two groups named 1 & 2. Earlier the demographic data of each individual was taken in consideration.

ASSESSMENT:

Ober test: Ober test was done by the therapist to assess the tightness of the iliotibial band. The subject was asked to be in a side lying position with lower leg flexed at hip and knee for stability. Therapist then passively abducted and extended the subjects upper leg with knee extended. Therapist then suddenly leaves the upper leg and if the upper leg remains abducted and if does not fall on the table, the test was considered to be positive for Iliotibial band tightness.

Patients will be assessed for quantity of iliotibial band pain using Numeric Pain Rating Scale (NPRS) 


INTERVENTION

GROUP A - Myofascial release technique: Ensure that the patient is relaxed and informed about the procedure, position the patient comfortably, typically side lying on their side with the affected leg on top. The therapist stands or sits beside the patient,The patient’s knee and hip should be flexed slightly for comfort.Use elbow to apply pressure along the length of the IT band. Start with gentle pressure and gradually increase as tolerated by the patient. Apply pressure perpendicular to the direction of the IT band, aiming to create a stretching sensation. Using slow, gliding strokes, apply pressure along the length of the IT band.Start from the hip and work downwards towards the knee.Maintain a steady pressure and adjust as needed to address areas of tension or tenderness,encourage the subject breath deeply through out the procedure,repeat this procedure for 6 minutes.after myofascial release was done apply icing to that area for 10 minutes.

GROUP B - Postional release technique: The patient may be supine or prone. The therapist stands on the side of the tightness, grasps the patient’s leg, and produces marked hip abduction and slight hip flexion with internal or external rotation to fine-tune the position.Maintain this postion for 90 second this procedure repeated 3 times.

Immediate post assessment of both the group was done by performing Ober test,measuring hip abduction and flexion range of motion,intensity of pain by nprs scores values was noted.

 
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