| CTRI Number |
CTRI/2022/12/047899 [Registered on: 06/12/2022] Trial Registered Prospectively |
| Last Modified On: |
03/12/2022 |
| 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 acupuncture and Muscle Release technique on side of thigh muscles in Runners. |
|
Scientific Title of Study
|
Comparison of Dry Needling and Myofascial release in Iliotibial band Syndrome in Runners. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Moksha S Shah |
| Designation |
Postgraduate student |
| Affiliation |
SVKMs NMIMS SUNANDAN DIVATIA SCHOOL OF SCIENCE |
| Address |
Department of Physiotherapy Nanavati Max Superspeciality Hospital SV Road Vile Parle (W)
V L Pherozshah Mehta Road, Vile parle (west) mumbai- 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8879504757 |
| Fax |
|
| Email |
mokshashah24.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khadijeh Menai |
| Designation |
Assistant Professor |
| Affiliation |
SVKMs NMIMS SUNANDAN DIVATIA SCHOOL OF SCIENCE |
| Address |
Department of Physiotherapy Nanavati Max Superspeciality Hospital SV Road Vile Parle (W)
V L Pherozshah Mehta Road, Vile parle (west) mumbai- 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9823390277 |
| Fax |
|
| Email |
khadijeh.menai@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moksha S Shah |
| Designation |
Postgraduate student |
| Affiliation |
SVKMs NMIMS SUNANDAN DIVATIA SCHOOL OF SCIENCE |
| Address |
Department of Physiotherapy Nanavati Max Superspeciality Hospital SV Road Vile Parle (W)
V L Pherozshah Mehta Road, Vile parle (west) mumbai- 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8879504757 |
| Fax |
|
| Email |
mokshashah24.ms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Nanavati Max Superspeciality Hospital SV Road Vile Parle (W) Mumbai Suburban- 400056 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Moksha Shah |
| Address |
Department of physiotherapy Nanavati Max Superspeciality Hospital SV Road Vile Parle (W) |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Moksha S Shah |
Nanavati Max Superspeciality Hospital |
Department of physiotherapy, Ground floor, Nanavati Max Superspeciality Hospital SV Road Vile Parle (W)
Mumbai (Suburban)
MAHARASHTRA |
8879504757
mokshashah24.ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Iliotibial band syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Needling |
One session of dry needling will be performed with disposable stainless steel needles. Areas will be cleaned with alcohol. 0.25 mm needles will be used. Needles will be inserted at an angle of 45 degree along the myofascial length and the Gerdy’s tubercle which is the site of pain in IT band syndrome.
Needles will be placed for a duration of 10 minutes and later disposed.
|
| Intervention |
Myofascial Release |
A vibrating foam roller will be used. Lie on the affected side and cross and place the upper thigh in front of the affected leg. Keep your affected leg straight and press the sole of your non-affected foot into the floor for support. Place both hands on the floor for stability, or prop yourself up on your right side. Foam roll down to your knee before rolling back up to your hip.
Foam rolling will be done for one minute and one minute break will be given and will be repeated 5 times hence the total treatment time including rest and foam rolling is 10 minutes |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Recreational runners with IT band syndrome 18-50 years.
2)Noble’s test positive.
3)Patients with trigger points along the IT band
|
|
| ExclusionCriteria |
| Details |
1)Any other musculoskeletal conditions of lower limbs like fractures.
2)Circulatory disorders in lower extremities like varicose veins.
3)Compromised immune system
4)Over an area of infection, open wound.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain pressure algometer.
|
Pre treatment and post treatment assessment on
the same day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ober’s test. |
Pre treatment and post treatment on the same day |
| Single leg mini squat test. |
Pre treatment and post treatment assessment on the same day. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
06/12/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of dry needling and myofascial release in iliotibial band syndrome in runners. INTRODUCTION:
Iliotibial band syndrome is one of the most common injuries in runners. It is a type of repetitive strain injury. A Recreational is defined as a person who had been running 1 to 3 weekly sessions for at least 6 months. Running related injuries can sometimes result in permanent dropouts if not treated efficiently. Dry needling for trigger points is an invasive method that involves inserting a tiny needle into the skin and muscle. Foam rolling has become one of the most commonly utilised instruments for the treatment of Myofascial pain as well as the repair of muscle tissue following injury caused by sports and exercise activities in recent years. Foam rolling has been proven to help with range of motion, muscular stiffness, late onset discomfort, and pressure pain threshold. Thus this study aims to compare the effects of dry needling and foam rolling on IT band syndrome and if one technique is more beneficial than another.
AIM: To study the comparative effects of dry needling and vibrating foam roller on IT band syndrome in runners OBJECTIVES: To study the effects of Dry needling on IT band syndrome. To study the effects of vibrating foam roller on IT band syndrome. To compare the effects of Dry needling and vibrating foam roller on IT band syndrome
PROCEDURE:
Ethical committee approval will be taken. The patients with Iliotibial band syndrome (ITBS) will be assessed for the same using Noble compression test. Patients with ITBS who meet the criteria of the study will be informed about the study and added to the study as voluntary enrolment. Informed written consent will be taken from each participant prior to the study. After asking for their consent their history, pre-intervention evaluation would be noted.
OUTCOME MEASURES:
Pain pressure algometer. Ober’s test. Single leg mini squat test.
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