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CTRI Number  CTRI/2024/03/063509 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   Myofascial therapy in back pain among fast bowlers 
Scientific Title of Study   Effect of Vacuumed Myofascial decompression therapy on Pain,tenderness,flexibility and performance among in young fast bowler with lower back pain 
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. Hisham Abdullah khan 
Designation  PG SCHOLAR 
Affiliation  Amity Institute of Health Allied Science 
Address  Room No. 07 Lower Ground Floor F1 Block Amity Institute of Health Allied Sciences Department of Physiotherapy, Amity University Noida Sector 125 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  09837504322  
Fax    
Email  hishamabdullah765@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Jasobanta Sethi 
Designation  Director 
Affiliation  Amity Institute of Health Allied Science 
Address  Room No. 07 Lower Ground Floor F1 Block Amity Institute of Health Allied Sciences Department of Physiotherapy, Amity University Noida Sector 125 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  98216620045  
Fax    
Email  jsethi@amity.edu  
 
Details of Contact Person
Public Query  
Name  Prof Dr Jasobanta Sethi 
Designation  Director 
Affiliation  Amity Institute of Health Allied Science 
Address  Room No. 07 Lower Ground Floor F1 Block Amity Institute of Health Allied Sciences Department of Physiotherapy, Amity University Noida Sector 125 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  98216620045  
Fax    
Email  jsethi@amity.edu  
 
Source of Monetary or Material Support  
Curative Physiotherapy Clinic Room No.01 Ground Floor Department of Physiotherapy Japani Gali,Block F, Joga Bai Extension,Okhla,New Delhi,Delhi 110025, 
 
Primary Sponsor  
Name  Hisham Abdullah khan 
Address  Amity Institute of Health Allied Science Amity university uttar pradesh noida- 201301 
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 
Dr Hisham Abdullah khan  Curative Physiotherapy clinic  Japani Gali, Block-f joga bai extension okhla New Delhi 110025
South
DELHI 		 09837504322

hishamabdullah765@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Amity Institute of Health Allied sciences Amity University Uttar Pardesh Institutional Amity university Uttar pardesh  Approved 
CURATIVE PHYISOTHERAPY CLINIC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional treatments  Conventional physiotherapy treatment administered was hot pack for 10 min followed by pelvic bridging, back extension exercises, knee to chest exercises, and cat–camel stretch, with ten repetitions per set three times/day and 2days/week. This was done at the clinic under the supervision of a physiotherapist.  
Intervention  Vacuumed Myofascial decompression therapy  Methods of Static Myofascial decompression vacuumed Therapy and Dynamic Myofascial decompression vacuumed Therapy. Apply the cups on the affected areas creating a vacuum with a manual pump pulling the skin into the cups. Pressure will be maintained for 4 minutes , after the release of pressure colorful bruises appears Static Myofascial decompression vacuumed Therapy is used to target deeper muscles in the back apply cups on the affected areas. Method of Dynamic Myofascial decompression release vacuumed therapy .Apply the cups on the affected areas creating a vacuum with a manual pump pulling the skin into the cups along with this active movement is performed ,pressure will be maintained for 4 minutes after the release of pressure colorful bruises appears. Conventional physiotherapy treatment administered was hot pack for 10 min followed by pelvic bridging, back extension exercises, knee to chest exercises, and cat–camel stretch, with ten repetitions per set three times/day and 2days/week. This was done at the clinic under the supervision of a physiotherapist. Dynamic vacuumed myofascial decompression plus conventional physiotherapy treatment. Method of Dynamic Myofascial decompression release vacuumed therapy .Apply the cups on the affected areas creating a vacuum with a manual pump pulling the skin into the cups along with this active movement is performed ,pressure will be maintained for 4 minutes after the release of pressure colorful bruises appears. Conventional physiotherapy treatment administered was hot pack for 10 min followed by pelvic bridging, back extension exercises, knee to chest exercises, and cat–camel stretch, with ten repetitions per set three times/day and 2 days/week. This was done at the clinic under the supervision of a physiotherapist  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  Inclusion Criteria:
Fast bowlers of Delhi Ncr
Only Male participant
Age 20-30 year
Lower Back pain (erector spinnae muscles) req 
 
ExclusionCriteria 
Details  Exclusion Criteria:
Traumatic injuries
Any neurological condition
Any types of infection  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Control Pain and tenderness and also to get flexibility  3weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Performance and flexibility  Baseline and after 3weeks 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 3 
Date of First Enrollment (India)   13/03/2024 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Fast bowlers frequently experience muscle stiffness and soft tissue injuries, notably affecting the erector spinae, or lower back muscles. These issues can significantly impair their performance in cricket and have broader implications for their social and physical well-being. When these muscles undergo distress, inflammation and pain can ensue in athletes.The current research emphasizes the effectiveness of Myofascial Decompression Vacuum Therapy as a treatment procedure for individuals dealing with pain, muscle stiffness, and compromised flexibility. This therapeutic approach aims to alleviate the distress in the affected muscles and enhance the overall well-being of athletes, particularly fast bowlers facing these specific challenges in their sport. 
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