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CTRI Number  CTRI/2024/03/063442 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of equilibrium exercise versus supervised exercise in tension headache among healthy individuals of aged 20-50 years 
Scientific Title of Study   To compare the effect of vestibular rehabilitation versus supervised exercise in tension headache among healthy individuals of aged 20-50 years 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zaki Anwer 
Designation  Professor 
Affiliation  Lovely Professional University  
Address  Department of Physiotherapy, Block 4,Room no-213-CH20,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India

Jalandhar
PUNJAB
144411
India 
Phone  9816285755  
Fax    
Email  zakianwer1974@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anmol Bhatia 
Designation  MPT Neurology PG Student  
Affiliation  Lovely Professional University  
Address  Department of Physiotherapy, Block 3,Room no-107,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India

Jalandhar
PUNJAB
144411
India 
Phone  8847646566  
Fax    
Email  anmolbhatiaz24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Zaki Anwer 
Designation  Professor 
Affiliation  Lovely Professional University  
Address  Department of Physiotherapy, Block 4,Room no-213-CH20,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India

Jalandhar
PUNJAB
144411
India 
Phone  9816285755  
Fax    
Email  zakianwer1974@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Block 3,Room no-101,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India  
 
Primary Sponsor  
Name  Zaki Anwer  
Address  Department of Physiotherapy, Block 4,Room no-213-CH20,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anmol Bhatia  Lovely Professional University Hospital  Department of Physiotherapy, Block 3,Room no-107,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India
Jalandhar
PUNJAB 		 8847646566

anmolbhatiaz24@gmail.com 
Dr Zaki Anwer  Lovely Professional University Hospital  Department of Physiotherapy, Block 3,Room no-101,School of Allied Medical Sciences, Lovely Professional University Phagwara-144411, Punjab, India
Jalandhar
PUNJAB 		 9816285755

zakianwer.1974@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lovely Professional University(IEC-LPU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tension Type Headache 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  kinaesthetic training with supervised exercise   For 5 weeks and 5 days a week for approximately 30-35min. It includes training with laser light attached to the helmet along with stretching and strengthening exercise 
Intervention  Vestibular Rehabilitation with supervised exercise   For 5 weeks and 5 days a week for approximately 40-45min it includes gaze stabilization, eye movement, stretching, and strengthening exercises  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Bilateral pain, localized to frontal, and parietal
2.Frequent episodes and chronic tension headache
3.Peri cranial tenderness
4.Headache for 15 consecutive days or more per month
5.Age 20-50 years
6.Good sleep posture
7.Non-pathological origin of pain in the neck
8.Mild or intermittent pain intensity of 4-5 level
9.Both Male and Female  
 
ExclusionCriteria 
Details  1.Patients suffering from nausea or vomiting and fainting syndrome
2.Head injury
3.Migraine attacks
4.Medication for neurosensory drugs
5.Psychiatric disorder
6.Carcinogenic history of neck
7.History of trauma to the neck
8.History of any spine surgery
9.Postural hypotension
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.VAS (visual analog scale)
2.HIT6(headache impact test 6)
3.DHI (dizziness handicap inventory)
 		 baseline,week3 and study completion week 5
 
 
Secondary Outcome  
Outcome  TimePoints 
NDI(Neck Disability Index)  baseline,week3 and study completion week 5 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 21/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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  

 Tension headaches are very common these days which affect the quality of life of individuals, and ultimately will affect their work and daily routine. There are no studies on the effect of vestibular rehabilitation on tension headaches so there is a need to study the comparison between the effect of vestibular rehabilitation and supervised exercise along with kinaesthetic training for a tension headache to know which is more beneficial.20 patients were selected based on inclusion and exclusion criteria. The subjects received both verbal and written information about the study and then the interested subjects were requested to sign the informed consent. The subjects were assigned into two groups, namely Group A and B. Group A subjects received Vestibular rehabilitation with supervised exercise, and Group B subjects received Kinaesthetic training along with supervised exercise. Pretest readings of peri cranial tenderness were evaluated by Visual analog scale, headache by headache impact test6, dizziness by dizziness handicap inventory, neck by neck disability index..The intervention was for 5 weeks, 5 days per week then post readings were recorded during 3rd week and again after the completion of the intervention.

 
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