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CTRI Number  CTRI/2021/07/035079 [Registered on: 23/07/2021] Trial Registered Prospectively
Last Modified On: 29/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparison between Active versus Passive Soft Tissue Therapies on Trigger Point in smartphone users.  
Scientific Title of Study   Comparison between the Immediate Effects of Active versus Passive Soft Tissue Therapies on Latent Trigger Point of Upper Trapezius in Smartphone Users Among the College Students. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Seema Anilkumar Tharani 
Designation  Student (Masters of Physiotherapy) 
Affiliation  Dr. A.P.J Abdul kalam College of Physiotherapy 
Address  Dr. A.P.J Abdul Kalam College of Physiotherapy, Orthopaedic department, Pravara Institute of Medical Sciences. Loni, Taluka- Rahata, Ahemdnagar

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9028252447  
Fax    
Email  seematharani320@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeraj Kumar 
Designation  Professor 
Affiliation  Dr. A.P.J Abdul Kalam College of Physiotherapy 
Address  Dr. A.P.J Abdul kalam college of Phsyiotherapy, Pravara Institute of Medical Sciences. Loni, Taluka: Rahata.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9005411557  
Fax    
Email  drneerajpt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Seema Anilkumar Tharani 
Designation  Student (Masters of Physiotherapy) 
Affiliation  Dr. A.P.J Abdul Kalam College of Physiotherapy 
Address  Dr. A.P.J Abdul kalam College of Physiotherapy, Pravara Institute of Medical Sciences

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9028252447  
Fax    
Email  seematharani320@gmail.com  
 
Source of Monetary or Material Support  
Dr. A.P.J Abdul kalam College of Physiotherapy, Pravara Institute OF Medical Sciences 
 
Primary Sponsor  
Name  Dr ApJ Abdul Kamlam College of Physiotherapy 
Address  Pravara Institute of Medical Sciences, Loni, Taluka- Rahata, Ahemdnagar 
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 
Seema Tharani  Pravara Institute of Medical Sciences- Deemed to be University  Hall no. 403, Department of Orthopaedic Physiotherapy, Dr. A.P.J Abdul kalam College of Physiotherapy, Loni, Taluka-Rahata
Ahmadnagar
MAHARASHTRA 		 9028252447

seematharani320@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  latent trigger point of upper trapezius  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active soft tisse therapy, passive soft tissue therapy, conventional physiotherapy  For Active soft tissue therapy: 3 times/session and each repetition maintained for 60 seconds, with a 15 seconds interval. Passive soft tissue therapy:3 times/session and each repetition maintained for 90 seconds, with a 15 seconds interval. Conventional physiotherapy: passive stretching of upper trapezius. 5 repetitions with 45 second hold.Hot Pack over trapezius muscle for 15 min 
Comparator Agent  Convetional Physiotherapy  Stretching of upper trapezius :5repetitions with 45second hold hot pack over trapezius for 15minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Students using smartphone for minimum 2 hours/day
2. Numeric Pain Rating Scale (NPRS) value between 4 to 7 out of 10 on palpation of upper trapezius.
3. Participants with minimum of one palpable nodule in upper trapezius
4. SAS-SV 31 for boys and 33 for girls
4. Participants having no pain in neck on rest or movement
5. Participants willing to sign the written inform consent form. 
 
ExclusionCriteria 
Details  1. Participants having active Trigger point
2. Recent history of trauma or fracture in cervical spine.
3. Skin disease around part to be treated.
4. Participants on any anti-inflammatory drugs
5. Sensory Disturbance near treating part 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pain Intensity by Numeric Pain Rating Scale
2. Cervical lateral flexion range of motion by universal Goniometer.
 		 Pre and Post Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Cervical range of motion: lateral flexion  pre and post intervention. 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
Final Enrollment numbers achieved (Total)= "219"
Final Enrollment numbers achieved (India)="219" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/07/2021 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 https://www.academia.edu/download/64138187/26.pdf 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·      the Aim of the study is  to compare the immediate effects of Active Versus Passive Soft Tissue Therapy in the participants with upper trapezius latent trigger point in smartphone users among college students. 

      Null Hypothesis (H0):There will be no significant difference in cervical range of motion and pain intensity in the participants with upper trapezius latent trigger point in smartphone users among college students when treated with Active or Passive Soft Tissue TherapyAlternative Hypothesis (H1):There will be a significant difference in cervical range of motion and pain intensity in the participants with an upper trapezius trigger point in smartphone users among college students when treated with Active or Passive Soft Tissue Therapy.

     Intervention:                                   

Group ‘A’: Active Soft Tissue Therapy + Conventional Physiotherapy, Treatment

·       Participants will be in a sitting position on an armless chair with back straight and both feet firmly planted on the floor.

·       The therapist standing behind the participant.

·       Therapist one hand placed over the head of the participant for support.

·       The thumb of the other hand over the trigger point of the upper trapezius.

·       The participant will be asked to simultaneously and actively change the muscle from shorted position to an elongated position. (contralateral side flexion of the side to be treated)

·       The technique will be repeated 3 times per session and each repetition will be maintained for 60 seconds, with a 15 seconds interval.

·        Conventional Physiotherapy Treatment

Group ‘B’: Passive Soft Tissue Therapy + Conventional Physiotherapy Treatment

·       Participants will be asked to relax as much as possible before pressure was applied.

·       The trigger point will be palpated and marked.

·       The participant will be asked to lie in the supine lying position.

·       The therapist will stand over the head end of the bed.

·       The therapist’s thumb is placed over the trigger point and then the pressure will be applied until the participant feels the pain, the contact with the trigger point will be made throughout the treatment.

·       Then the therapist will passively move the patient’s head and neck in ipsilateral lateral flexion and contralateral rotation (5-8 degrees) so that participants report a 75% reduction in pain.

·       This position will be maintained for 90 seconds followed by 15-sec rest and followed by a passive return of the body part to an anatomically neutral position repeat 3 times. and performed 3 times.

·       Conventional Physiotherapy Treatment

Group ‘C’:  Conventional Physiotherapy Treatment

·       Conventional treatment included passive stretching of the upper trapezius muscle.

·       Participants will be in a sitting position on an armless chair with back straight and both feet firmly planted on the floor.

·       The therapist standing behind the participant

·       Passive stretching for trapezius muscle will be given for 5 repetitions with a 45-second hold

·       Application Hot Pack over trapezius muscle for 15 min

 

 

 

 

 

 

 





 
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