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CTRI Number  CTRI/2024/12/078509 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
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   Evaluating the impact of Ultrasound Therapy and Trigger Point Massage on Calf Muscles Pain in Male Athletes: A Pilot Study 
Scientific Title of Study   Effectiveness of Trigger Point Release with Therapeutic Ultrasound: A combination therapy for Myofascial Pain in Calf muscles among Male Athletes. 
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 Sumera Khan 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Room No. B316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7827777195  
Fax    
Email  sumera.khan@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr. Sumera Khan  
Designation  Associate Professor 
Affiliation   
Address  Room No. E004, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7827777195  
Fax    
Email  sumera.khan@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Shubham Kumar 
Designation  Student 
Affiliation   
Address  Room No. B316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9973426096  
Fax    
Email  shubhammishra03086@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha Internationa Circuit, Grater Noida, G.B. Nagar, Uttar Pradesh, India 203201 
 
Primary Sponsor  
Name  GALGOTIAS UNIVERSITY 
Address  Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, G.B. Nagar, Uttar Pradesh, India- 203201 
Type of Sponsor  Research 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 Sumera Khan  Galgotias University  Room No. B316, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH 		 7827777195

sumera.khan@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Therapeutic ultrasound   Therapeutic ultrasound is given to the patient to reduce the calf pain. Therapeutic ultrasound treatment is applied on male athletes patient having myofascial calf pain. It is applied for 5-7 min. 
Intervention  Trigger point release with therapeutic ultrasound   Trigger point release with therapeutic ultrasound is a technique that uses ultrasound to release trigger point in calf muscles and reduce pain 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Male 
Details  1. Male participants only, since study focuses on male athletes.
2. Patients with myofascial pain for calf muscles were only included.
3. Patient with exquisite spot tenderness of a nodule on a taut band were only included.
4. Participants between the ages 18-25. 
 
ExclusionCriteria 
Details  1. Patient with dermatitis were excluded.
2. Patient with any open wound and scar over Calf muscles were excluded.
3. Patient with sensory deficits were excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogous Scale  2 weeks and 5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/01/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This pilot study explores the combined effects of therapeutic ultrasound and myofascial release techniques. Training on pain, swelling, tenderness and overall wellbeing in male athletes suffering from myofascial pain in calf muscles. Myofascial pain is a common complaint among the sports persons because of various risk factors like wearing unsupported shoes, inadequate warm up, lack of hydration, poor flexibility, overuse of calf muscles, stress induced tension and vascular problems. The common method of treatment are myofascial trigger point release technique, therapeutic ultrasound, moist heat, active movement, acupuncture etc. Therapeutic ultrasound is a method which help in movement of drug through skin into the subcutaneous tissue, this process is called phonophoresis. Trigger point therapy is a soft tissue manipulation done to desensitize trigger point, improve circulation and thereby aid and pain reduction. 
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