| 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
|
|
|
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
|
|
|
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. |