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CTRI Number  CTRI/2023/07/054744 [Registered on: 05/07/2023] Trial Registered Prospectively
Last Modified On: 10/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Cervicothoracic Manipulations, Muscle Energy Technique & Sleep Hygiene in Treatment of Migraine Headache 
Scientific Title of Study   Efficacy of Cervicothoracic Manipulations, Muscle Energy Technique and Sleep Hygiene in Management of Migraine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parul Sharma 
Designation  Masters Student 
Affiliation  Guru Jambheshwar University of Science And Technology 
Address  Department of Physiotherapy, Guru Jambheshwar University of Science And Technology, Neurophysiotherapy, Hisar

Hisar
HARYANA
125001
India 
Phone  7015851831  
Fax    
Email  ps967292@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Malik 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science And Technology 
Address  Department of Physiotherapy, Guru Jambheshwar University of Science And Technology Hisar Haryana

Hisar
HARYANA
125001
India 
Phone  9896221262  
Fax    
Email  malik_manoj@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science And Technology 
Address  Department of Physiotherapy, Guru Jambheshwar University of Science And Technology Hisar Haryana

Hisar
HARYANA
125001
India 
Phone  9306714673  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar, Haryana 
 
Primary Sponsor  
Name  Guru Jambheshwar University of Science Technology Hisar Haryana 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Type of Sponsor  Other [Government University] 
 
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 
Parul Sharma  OPD, Health Centre, Guru Jambheshwar University of Science and Technology, Hisar  Department of Physiotherapy, Neurophysiotherapy, Room no.4,5 Guru Jambheshwar University of Science and Technology, Hisar
Hisar
HARYANA 		 7015851831

ps967292@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Guru Jambheshwar University of Science and Technology, Hisar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G431||Migraine with aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cervicothoracic manipulation therapy (CT), posture correction exercises, and sleep hygiene   The cervical and upper thoracic intervertebral joints will be adjusted during the procedure. The CT manipulation will be performed first on the right side, and then on the left side. A maximum of 2 attempts will be performed for each side. In posture, correction exercises stretching, and strengthening exercises of the cervical and thoracic spine were performed. Strengthening exercises were performed with the help of theraband. treatment Duration:three times per week for two weeks 
Intervention  Muscle Energy Technique, Posture Correction Exercises and Sleep Hygiene  MET of suboccipital, trapezius, and sternocleidomastoid muscles were performed. individuals were stretched with MET on both the left and right sides. Along with MET, posture correction exercises and sleep hygiene are administered thrice per week for two weeks. 
Comparator Agent  Posture correction exercises and sleep hygiene practice  Stretching and Strengthening of Cervical and Thoracic muscles were performed. In each session, stretching activities were done with a 6–10 second hold and one set of 10 repetitions for a particular muscle, while strengthening exercises were done with one set of 15 repetitions using a theraband and also the patients were asked to complete the sleep hygiene index and practice sleep hygiene behaviors 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering from migraine headache
Patients who fulfilled the International classification of Headache disorder-3
Age group between 18-65 years
Both male and female
 
 
ExclusionCriteria 
Details  Patients suffering from headache other than migraine
Spinal radiculopathy
Depression
Pregnancy
Degenerative diseases
Un-cooperative patients
Recent surgeries or fracture of cervical spine
Contraindicated to CT manipulation
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Headache impact test questionnaire (HIT-6)
Disability: Headache disability index questionnaire (HDI)
Sleep hygiene index (SHI)
 		 At baseline, after 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/07/2023 
Date of Study Completion (India) 12/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/09/2023 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 A significant public health issue that affects both individuals and society is migraine. Migraine is a periodic condition with several phases that include a premonitory phase, brief neurological symptoms (i.e., migraine aura), a strong headache attack, and a postdrome phase. The most common type of headache diagnosed by neurological services in Asia is migraine . With a 14.7% prevalence, migraine is the third most common disorder in the globe. One of the most prevalent types of headache, migraine is typically recognized by its hemicranial feature, recurrence, aura, and relationship with sensory problems, however, this isn’t always the case. As the cases of Migraine are on rise globally. Literature shows various techniques for treatment of Migraine. Previous studies have examined the effect of Chiropractic management of migraine. However, no study directly shows the effects of cervicothoracic manipulation, muscle energy technique (MET) and sleep hygiene techniques for treating migraine therefore the objective of the study is to find that which technique will improve migraine in patients. 

 

 
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