| 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
|
|
|
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
|
|
|
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
|
AIM- To 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. |