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CTRI Number  CTRI/2024/12/078424 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 17/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [RANDOMIZED CLINICAL TRIAL]  
Study Design  Other 
Public Title of Study   Comparing the Immediate Effects of two Hands on Method on Young Adults with Trapezius Muscle Pain: A Randomized Clinical Trial 
Scientific Title of Study   Immediate effect of Fascial Distortion Model versus Kinetic Chain Activation Technique in Young Adults with Trapezitis: A Randomized Clinical Trial. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Santosh Metgud 
Designation  Professor and Vice Principal 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advance Physiotherapy, Room No. 39, Department of Orthopedic Manual Therapy, Room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru nagar, Belagavi Karnataka
Advance Physiotherapy, Room No. 39, Department of Orthopedic Manual Therapy, Room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru nagar, Belagavi Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9880088400  
Fax    
Email  santoshmetgud@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Santosh Metgud 
Designation  Professor and Vice Principal 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advance Physiotherapy, Room No. 39, Department of Orthopedic Manual Therapy, Room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru nagar, Belagavi Karnataka
Advance Physiotherapy, Room No. 39, Department of Orthopedic Manual Therapy, Room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru nagar, Belagavi Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9880088400  
Fax    
Email  santoshmetgud@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Kanad Anil Dandgavhal 
Designation  Post Graduate Student 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advance Physiotherapy, Room No. 39, Department of Orthopedic Manual Therapy, Room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru nagar, Belagavi Karnataka
Advance Physiotherapy, Room No. 39, Department of Orthopedic Manual Therapy, Room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru nagar, Belagavi Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9423194694  
Fax    
Email  dandgavhal.kanad02@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research, Belagavi, Karnataka, India 590010 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research 
Address  KLE Academy of Higher Education and Research, Belagavi, Karnataka, India 590010 Edit || Delete  
Type of Sponsor  Private medical college 
 
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 Santosh Metgud  KLEs Dr Prabhakar Kore Hospital and Medical Research  KLE Academy of Higher Education and Research, Belagavi, Karnataka, India 590010
Belgaum
KARNATAKA 		 9880088400

santoshmetgud@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE ACADEMY OF HIGHER EDUCATION  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  
Type  Name  Details 
Intervention  Fascial Distortion Model (FDM)  Fascial Distortion Model (FDM) is a therapeutic approach focusing on treating pain and dysfunction. It involves identifying and correcting distortions in the bodys fascial tissue to promote healing. This technique will be given for 30-60 sec. Along with this Conventional Therapy will be given for 25 mins. 
Comparator Agent  Kinetic Chain Activation Technique (KCAT)  Kinetic Chain Activation Technique (KCAT) is a method that targets the bodys interconnected muscle groups. It focuses on activating the kinetic chain to restore optimal movement patterns and improve function. This technique will be repeated for 3 times. Along with this Conventional Therapy will be given for 25 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  Individuals with unilateral and bilateral trapezitis, Pain intensity of 4-7 on VAS and presence of at least one active trigger point
in a taut band in the upper trapezius OR Individuals with grade 2 and 3
trapezius muscle Tenderness based on “Tenderness grading scale" 
 
ExclusionCriteria 
Details  History of surgery to neck or upper back, Diagnosed cases of cervical spine or shoulder pathologies like radiculopathy or
myelopathy.
History of a whiplash injury.
History of trauma or fractures in the neck or upper back or shoulder region.
Diagnosed cases of vestibular dysfunction.
Neck deformities like torticollis 
 
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 Threshold, Pain and Range of Motion.  Pain Pressure Threshold, Pain and Range of Motion will be assessed using Pressure Algometer, Visual Analogue Scale and Universal Goniometer respectively. This outcomes will be taken Pre intervention and immediately after the session. 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) 28/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/03/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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 determine the immediate effect of Fascial Distortion Model (FDM) and KCAT in young adults with Trapezitis.
Inclusion Criteria:
• Individuals of all genders aged 18-26 years willing to participate
• Individuals with unilateral and bilateral trapezitis
• Pain intensity of 4-7 on VAS and presence of at least one active trigger point in a taut band in the upper trapezius OR Individuals with grade 2 and 3 trapezius muscle Tenderness based on “Tenderness grading scale”[4]
Exclusion Criteria:
• History of surgery to neck or upper back
• Diagnosed cases of cervical spine or shoulder pathologies like radiculopathy or myelopathy
• History of a whiplash injury
• History of trauma or fractures in the neck or upper back or shoulder region
• Diagnosed cases of vestibular dysfunction
• Neck deformities like torticollis
Outcome Measures:
Assessment of Pain Pressure Threshold using Pain Pressure Algometer.
Assessment of Pain Intensity using Visual Analogue Scale (VAS).
Assessment of Cervical Range of Motion using Universal Goniometer.
Procedure:
The study participants will then be Randomly allocated in two different groups.
Group A will receive Fascial Distortion Model (FDM)
Group B will receive Kinetic Chain Activation Technique (KCAT)


 
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