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CTRI Number  CTRI/2024/03/064595 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   Bowen Therapy versus Myokinetic Stretching technique on pericranial muscles with tension type headache - A randomized clinical trial 
Scientific Title of Study   Effect of bowen therapy versus myokinetic stretching technique on pericranial muscles in individuals with tension type headache: A Randomized Clinical trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apeksha Hungund 
Designation  Assistant Professor 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8971646761  
Fax    
Email  apeksha_hungund@klekipt.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Apeksha Hungund 
Designation  Assistant Professor 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi, Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  8971646761  
Fax    
Email  apeksha_hungund@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Mrunmai Vaidya 
Designation  Under Graduate student  
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER Institute of Physiotherapy, Nehru Nagar,Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  8451944817  
Fax    
Email  iammrunmai@gmail.com  
 
Source of Monetary or Material Support  
KLE Academy of Higher Education and Research , JNMC Campus, Nehru Nagar, Belagavi, 590010 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research 
Address  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 Apeksha Hungund  KLEs DR Prabhakar kore hospital  opd no. 39 ,sagar ward , g -1 dr. prabhakar kores Kle medical and research Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA 
8971646761

apeksha_hungund@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  bowen therapy   intervention will be carried out for 20 min for 2 weeks every alternate day 
Comparator Agent  myokinetic stretching technique   intervention will be carried out for 20 min for 2 weeks every alternate day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Individuals with Tension Type Headache 
 
ExclusionCriteria 
Details  Subjects with other types of headache like migraine or cervicogenic headache
Any comorbid factors like congenital, malignant, autoimmune and neurological conditions involving head and neck
Any trauma to head and neck region less than 6 months
Any diagnosed systemic illness
Individuals on medications for tension type headache
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
visual analogue scale   at baseline and
at the end of 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
visual analogue scale  pre- at baseline
post - 2 weeks  
headache disability questionaire   pre- at baseline
post - 2 weeks 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   04/04/2024 
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="6"
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  

 To evaluate and compare the effect of Bowen’s therapy versus Myokinetic stretching technique in individuals with tension type headache

Inclusion  Criteria

      Both male and female students in the age group 18-25 years[7]

    Bilateral location [2]

           Recurrent mild to moderately intense headaches [2]

       Headaches that feel pressing or tightening [2]

         No episodes of nausea or vomiting during headache [9]

         No exacerbation with ordinary physical activity [2]

         Headache Disability Index score ranging from 10-48 (mild to moderate)

 

 Exclusion  Criteria:

   Subjects with other types of headache like migraine or cervicogenic headache

  Any co morbid factors like congenital, malignant, autoimmune and neurological conditions involving head and neck

   Any trauma to head and neck region less than 6 months

   Any diagnosed systemic illness

   Individuals on medication for tension type headache

         Group A (Bowen Therapy)

The individuals will be positioned in prone lying position. Thumb is placed on top of the pericranial muscle. To create a challenge or pressure against the muscle, silently hook the thumb into the lateral edge of the muscle. As the nervous system senses a tension that indicates "something is about to occur," create a brief pause. The muscle will pluck or plop when we start to flatten the thumb in a medial direction. Toughen the muscle, carry the skin. Starting with the thumbs on the left side of the body and moving on to the fingers on the right. To allow the hands to play the muscles simultaneously, they are often placed on the back with an inch separating the thumbs and fingers. Intervention will be given on alternate days for 2 weeks. The duration of treatment per session will be 20 minutes.

 

         Group B (Myokinetic Stretching Technique)

The therapist had the subject lie down on the plinth with their head resting at the edge. The therapist then used one hand to hold the neck in cervical lateral flexion to the other side, which stretched the trapezius muscle. Myofascial release was administered by continuously pressing on the affected trapezius for five to ten seconds. To pick up the slack, a gentle myofascial stretching force was used, and it was maintained until a release happened. Intervention will be given on alternate day basis for 2 weeks. 4 sets of 15 stretches with intermittent rest of 3 minutes will be given.

Both groups A and B will be given conventional treatment comprising of ergonomic education, chin retractions, passive stretching to upper trapezius muscles and cryotherapy to posterior cervical region will be given.


 
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