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CTRI Number  CTRI/2022/01/039861 [Registered on: 31/01/2022] Trial Registered Prospectively
Last Modified On: 31/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Instrument-Assisted Soft Tissue Mobilization Versus Vibration Massage On Hamstring Performance In Healthy Male Football Players 
Scientific Title of Study   Instrument-Assisted Soft Tissue Mobilization Versus Vibration Massage On Hamstring Flexibility And Strength, Knee Proprioception And Agility In Healthy Male Football Players: A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1273-0662  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Odedra Vishal Prakashbhai 
Designation  MPT Student  
Affiliation  C M Patel College of Physiotherapy 
Address  Department of Sports and Fitness, C M Patel College of Physiotherapy, Civil Hospital Campus, Sector-12

Gandhinagar
GUJARAT
382016
India 
Phone  9879897897  
Fax    
Email  vshalodedra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parth Trivedi  
Designation  Lecturer  
Affiliation  C M Patel College of Physiotherapy 
Address  Department of Sports and Fitness, C M Patel College of Physiotherapy, Civil Hospital Campus, Sector-12

Gandhinagar
GUJARAT
382016
India 
Phone  9979017118  
Fax    
Email  drparthtrivedi@live.in  
 
Details of Contact Person
Public Query  
Name  Odedra Vishal Prakashbhai 
Designation  MPT Student  
Affiliation  C M Patel College of Physiotherapy 
Address  Department of Sports and Fitness, C M Patel College of Physiotherapy, Civil Hospital Campus, Sector-12

Gandhinagar
GUJARAT
382016
India 
Phone  9879897897  
Fax    
Email  vshalodedra@gmail.com  
 
Source of Monetary or Material Support  
C M Patel College of Physiotherapy, Civil Hospital Campus, Sector-12, Gandhinagar, Gujarat, India 
 
Primary Sponsor  
Name  C M Patel College of Physiotherapy 
Address  Civil Hospital Campus, Sector-12, Gandhinagar 
Type of Sponsor  Other [Academic Institution] 
 
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 Parth Trivedi  C M Patel College of Physiotherapy  Department of Sports and Fitness C M Patel College of Physiotherapy, Civil Hospital Campus, Sector-12
Gandhinagar
GUJARAT 		 9979017118

drparthtrivedi@live.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, C M Patel College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hamstring Flexibility  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A - Moist heat with Stretching and Strengthening Exercise  Moist heat over bilateral hamstring muscle for 15-20 mins, 2 sessions/week for 6 weeks. Total: 12 sessions. Bilateral Static hamstring stretching with 3 sets with 30s hold each, 2 session/week for 6 weeks. Total: 12 sessions. Hamstring Strength Training with 3 sets of 10 repetitions, 2 session/week for 6 weeks. Total: 12 sessions.  
Intervention  Group B: Instrument Assisted Soft Tissue Mobilization  Instrument Assisted Soft Tissue Mobilization on bilateral hamstring muscle with patient in prone lying position for 5mins/session with 2 session/week for 6 weeks. Total: 12 sessions. 
Intervention  Group C: Vibration Massage  Vibration Massage with Beurer MG70 machine on Bilateral hamstring muscle with patient in prone lying position for 5 mins/session with vibratory waves at 47Hz frequency with average of 2 session/week for 6 weeks. Total: 12 sessions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  1. All asymptomatic healthy male football players aged between 18 to 30 years will be included.
2.Any Limb dominancy.
3.BMI between 18-24 kg/m2.
4. Duration of Football activities for at least 2 years with at least 4 months a year and a frequency of a minimum of 270 minutes per week.
5. Can read and write and understand English.
6. Active Knee Extension should be <33 degree.
 
 
ExclusionCriteria 
Details  1. Any history of lower limb fractures and dislocation within past 12 months.
2. Acute or Chronic upper & lower limb injuries.
3. Any lower limb musculoskeletal surgery in the past 6 months.
4. Hamstring tears in the past 6 months.
5. Any other systemic illness.
6. Not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Back Saver Sit and Reach test (BSSR)
2.iHandy Level smartphone application.
3.Single leg hamstring bridge test
 		 All the outcome measures will be measured at Baseline and after completion of treatment protocol i.e. after 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1.5-0-5 change of direction hamstring agility test.  The outcome measures will be measured at Baseline and after completion of treatment protocol i.e. after 6 weeks. 
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="147" 
Final Enrollment numbers achieved (Total)= "147"
Final Enrollment numbers achieved (India)="147" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 12/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/01/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In football, muscle strain injuries are a cause of considerable disability among which hamstring injuries are amongst the most common sports injuries, accounting for 12-16% of all athletic injuries in football, especially when acceleration is required. 2 In high school football, muscle strains have been reported to comprise between 12% and 24% of all injuries. 3 They can be challenging to manage and usually have a high recurrence rate, of about one third within the first two weeks. Many risk factors leading to hamstring strains have been proposed, such as decreased flexibility, eccentric hamstring strength deficits or eccentric hamstring strength asymmetries, poor core stability involving the gluteal and trunk muscles and previous hamstring injury. 4 During strenuous activities like sprinting, study participants with less flexible hamstring tend to present with more relative elongation in all 3-hamstring muscle, translating to higher internal forces development.5 Physiotherapy interventions targeting flexibility may be important in controlling the amount of peak elongation reached during participation in high-intensity sports activities and normalization of hamstring eccentric strength deficits at hamstring lengthened states either due to the changes in eccentric strength in isolation or in conjunction with associated changes in fascicle length of the hamstring.
Hamstring flexibility and neuromuscular activation patterns may be important predictors not only for hamstring muscle strains but also for knee joint injury. Hamstring lack of flexibility is typically managed using static and dynamic stretching and also using Instrument-Assisted Soft Tissue Mobilization (IASTM) or therapeutic hand or Vibration Massage.6 Instrument-Assisted Soft TissueMobilization is intended to promote connective tissue remodeling by releasing adhesions using stainless steel tools and eliciting a local inflammatory response. Several case studies have been published documenting successful improvement in range of motion following Instrument Assisted Soft Tissue Mobilization. However, this intervention is under research and the evidence is inconclusive, largely due to variations in technique, tools, and duration of application. 7 Whereas, Massage is a physical therapy intervention with purported biomechanical (flexibility increase, tissue adhesion prevention), physiological (increased skin and muscle temperature, increased blood flow and parasympathetic activity), neurological (decrease muscle tension and pain perception) and psychological advantages. 8 Vibration massage, on the other hand, consists of vibration massage input to muscles, utilized to promote relaxation and flexibility gains, usually with the aid of an electromechanical device. 9 With Vibration Massage, Massage parameters such as the Vibration Massage frequency, duration, and amplitude can be better controlled in relation to difficulties in applying constant pressure, technique and duration with manual massage.
Currently, no consensus exists as the most appropriate Physiotherapy protocol for hamstring strength in football players. A wide array of Physiotherapy protocol has been recommended for increasing the hamstring strength in football players. These Physiotherapy protocols have different theoretical mechanisms of action, but all have the same aim, to improve flexibility, strength and function. There are various literature supporting Conventional Physiotherapy, Instrument-Assisted Soft Tissue Mobilization and Vibration Massage effects on hamstring flexibility and strength, knee proprioception and agility but there is no available evidence of comparing the effects of Conventional Physiotherapy, Instrument Assisted Soft Tissue Mobilization and Vibration Massage effects on hamstring flexibility and strength, knee proprioception and agility in Healthy Male Football Players. Thus, the need for the study is to compare the effects of Conventional Physiotherapy, Instrument Assisted Soft Tissue Mobilization and Vibration Massage effects on hamstring flexibility and strength, knee proprioception and agility in Healthy Male Football Players. 
 
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