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CTRI Number  CTRI/2024/11/077003 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Massage Therapy and Muscle Release on muscles of Neck and Upper back In Undergraduate Physiotherapy Students having Neck Muscle Pain and Tightness due to Exam Related Stress 
Scientific Title of Study   Effectiveness Of Soft Tissue Manual Therapy For Exam Stress Induced Trapezitis In Undergraduate Physiotherapy Students : A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Peeyoosha Gurudut 
Designation  MPT PhD Professor and HOD Orthopedic physiotherapy 
Affiliation  KLE Institute of Physiotherapy 
Address  KLE Academy of Higher Education and Research INSTITUTE OF PHYSIOTHERAPY, Room no 21, Research Lab Unit ,JNMC Campus,Nehru nagar, Belagavi, Karnataka, India.
nil
Belgaum
KARNATAKA
590010
India 
Phone  9448745648  
Fax    
Email  peeyooshagurudut@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Peeyoosha Gurudut 
Designation  MPT PhD Professor and HOD Orthopedic physiotherapy 
Affiliation  KLE Institute Of Physiotherapy 
Address  KLE Academy of Higher Education and Research,INSTITUTE OF PHYSIOTHERAPY, JNMC campus, Nehru Nagar, Belagavi.
nil

KARNATAKA
590010
India 
Phone  9448745648  
Fax    
Email  peeyooshagurudut@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Peeyoosha Gurudut 
Designation  MPT PhD Professor and HOD Orthopedic physiotherapy 
Affiliation  KLE Institute Of Physiotherapy 
Address  KLE Academy of Higher Education and Research INSTITUTE OF PHYSIOTHERAPY,Room number 21, Research lab unit, J.N.Medical College Campus,Nehru Nagar, Belgaum,Karnataka, India.
nil

KARNATAKA
590010
India 
Phone  9448745648  
Fax    
Email  peeyooshagurudut@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research INSTITUTE OF PHYSIOTHERAPY, Room no 21, Research Lab Unit ,JNMC Campus, Nehru nagar, Belagavi, Karnataka, India.  
 
Primary Sponsor  
Name  KLE Institute of physiotherapy 
Address  KLE Institute of physiotherapy, JNMC Campus, Nehru nagar, belagavi, karnataka 
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 Peeyoosha Gurudut  KLE Institute Of Physiotherapy  KLE Academy of Higher Education and Research INSTITUTE OF PHYSIOTHERAPY, Research lab unit, Room number 21, Nehru Nagar, Belgaum, Karnataka, India, 590010
Belgaum
KARNATAKA 		 9448745648

peeyooshagurudut@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee KLEU Institute of Physiotherapy.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Trapezitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ergonomic advice  This group will only receive education on ergonomics and sitting posture 5 days before the commencement of exams. To help mitigate the effects of exam stress induced trapezitis, students in control group should focus on : Proper sitting posture- where they should sit with back straight and supported, keeping their shoulders relaxed and your feet flat on the floor. They should avoid slouching or hunching forward to reduce strain on trapezius muscle. Screen and desk height- they will be advised to adjust their chair and desk height to ensure the computer or study materials are at eye level which will prevent excessive forward head posture. Frequent breaks and stretching- They will be advised to take a short break of 5 minutes every 30-40 minutes and to stand up, stretch their neck, shoulders and back, and walk around to reduce stiffness. Awareness of tension- They will be advised to stay mindful about their body during the intense study periods, frequently check in with their posture and consciously try to relax the shoulders and neck to prevent the buildup of stress. total time this treatment will be given is 5 minutes  
Intervention  myofascial release and massage therapy  Myofascial release for posterior cervical musculature: Students will be made to lie on the couch comfortably ensuring the neck is relaxed. Small amount of petroleum jelly will be applied to reduce the friction. Both hands will be placed at the base of the occiput, pulling upward toward the top of the subjects head. The thumbs will gently rest on the neck’s lateral muscles, while the opposite hand will be positioned on the upper thoracic spine.A general stretch will be applied by pulling upward from the occiput and downward from the thoracic region simultaneously. Initial traction will be applied just enough to offset the weight of the subject’s head. This stretch will be held for 90 seconds, followed by a release, and then traction will be gradually increased with each subsequent stretch. After each release, capital extension will progressively improve. The cycle of releasing and stretching will continue until an end point is reached. Massage therapy for upper trapezius : Students will be made to lie prone on the couch comfortably with upper trapezius muscle exposed. Small amount of petroleum jelly will be applied over the upper trapezius area to reduce the friction. Students will be given effleurage and kneading techniques using moderate pressure each lasting for 5 minutes.5 consecutive sessions of soft tissue manual therapy will be given prior to the commencement of the exams along with ergonomic advice as described above. Total treatment duration will be 15 minutes every session  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Both male and female undergraduate physiotherapy students with age group of 18-23 years.
Having trigger points in upper trapezius of grade 2 and above tenderness by palpation method.
Having stress according to perceived stress scale with score of 14 and above13.
Having neck stiffness or pain in recent fifteen days.
Subjects having formative exam stress
 
 
ExclusionCriteria 
Details  Subjects having previous history of neck pain and stiffness.
Subjects having skin diseases or infection.
Subjects having cervical radiculopathy or known case of prolapse intervertebral disc.
Subjects having migraine headache.
Subjects having traumatic neck or upper limb injury or surgeries of spine or upper limb in the past.
Subjects having somatic or psychological disorder.
Subjects having recurrent neck pain and back pain and taking any medications for it presently.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

Academic stress questionnaire


 
at baseline


 
 
Secondary Outcome  
Outcome  TimePoints 
Pain pressure threshold   at baseline 
Patient satisfaction scale
 		 after 1 week 
goniometry


 		 at baseline 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   29/11/2024 
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)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [peeyooshagurudut@klekipt.edu.in].

  6. For how long will this data be available start date provided 20-11-2024 and end date provided 20-02-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   In this study there will be 2 groups control group and experimental group the control group would recieve ergonomic advice and the experimental group will recieve myofascial release, massage therapy along with ergonomic advice.
The purpose of this study is to determine the effectiveness of soft tissue manual therapy in exam stress induced trapezitis on undergraduate physiotherapy students
The screening for the subjects will be done according to the outcome measures like academic stress scale, percieved stress scale, pressure algometer. brief demographic data will be obtained and participants will be treated everyday for 5 times a week for 2 weeks
inclusion criteria includes : both male and female physiotherapy undergraduates of age 18 to 23, having trigger point in trapezius of grade 2 and above, having stress according to percieved stress scale with score of 14 and above, havig neck stiffness or pain in recent 15 days, subjects having formative exam stress. 
Exclusion criteria includes: Subjects having previous history of neck pain and stiffness, subjects having skin diseases or infection, subjects having cervical radiculopathy or known case of prolapse intervertebral disc, subjects having migraine headache, subjects having somatic or psychological disorder, subjects having recurrent neck pain and back pain and taking any medications for it presently.
 
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