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CTRI Number  CTRI/2019/12/022414 [Registered on: 18/12/2019] Trial Registered Prospectively
Last Modified On: 16/07/2020
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Neck Manipulation in Headache 
Scientific Title of Study   Efficacy of Cervical Spine Manipulation in Patient suffering from Migraine 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manoj Malik 
Designation  Assistant professor 
Affiliation  Guru Jambeshwar University of Science and technology Hisar Haryana 
Address  Department of Physiotherapy
Guru Jambeshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  9896221262  
Fax    
Email  malik_manoj@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jambeshwar University of Science and Technology Hisar Haryana 
Address  Department of Physiotherapy
Guru Jambeshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonu Punia 
Designation  Assistant Professor 
Affiliation  Guru Jambeshwar University of Science and Technology Hisar Haryana 
Address  Department of Physiotherapy
Guru Jambeshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA
125001
India 
Phone  9466373990  
Fax    
Email  sonu.punianeuropt@gmail.com  
 
Source of Monetary or Material Support  
Vinita PG student Department of Physiotherapy Guru Jambeshwar University of Science and Science and Technology Hisar Haryana 
 
Primary Sponsor  
Name  Department of Physiotherapy 
Address  Department of Physiotherapy Guru Jambeshwar University of Science and Science and Technology Hisar Haryana 
Type of Sponsor  Other [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 
Ms Vinita  Department of Physiotherapy  OPD room no.4 Department of Physiotherapy Guru Jambeshwar University of Science and Science and Technology.
Hisar
HARYANA 
9896220348

vinita3551@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cervical Manipulation   Thrice in a week for 2 weeks 
Comparator Agent  Placebo  sham manipulation of cervical spine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient suffering from migraine headache and fulfilling the international classification of headache disorders 3 beta version of International headache society
Age group between 18-65 year  
 
ExclusionCriteria 
Details  Patients suffering from headache other than migraine.
Spinal radiculopathy
Depression
Uncooperative patients.
Osteoporosis
Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain VAS HIT-6
Disability Headache Disability Index Questionnaire 
1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/12/2019 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
committed 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Migraine is a common health problem with substantial health and socioeconomic costs. On the recent global burden of disease study, migraine was ranked as the third most common condition. About 15% of the general population have migraine.The socio economic costs of  migraine are enormous due to its high prevalence & disability during attacks.8 million adults in the united states are estimated to be migraine sufferers; of these 91% experience migraine associated disability.Migraine is usually unilateral with pulsating and moderate/severe headache which is aggravated by routine physical activity, and is accompanied by photophobia and phonophobia , nausea and sometimes vomiting. Migraine exists in two major forms, migraine without aura and migraine with aura. Aura is reversible neurological disturbance of the vision, sensory, and/or speech, occurring prior to the headache.The origin of the migraine is debated. The painful impulse may originate from the trigeminal nerve central/peripheral mechanisms. Extra cranial pain sensitive structures include the skin, muscle, arteries periosteum and joints. Skin is sensitive to all forms of usual form of pain stimuli, while the temporal and neck muscles may especially be sources for pain and tenderness in migraine. Acute pharmacological treatment such as analgesic or triptans is usually the first treatment option for migraine in adults. However, not all attacks respond to acute treatment. Some patient have contraindication to triptans such as vascular disease or pregnancy and triptans are not effective or approved during the aura phase of a migraine attack.Migraine might originate from a complexity of nociceptive afferent responses involving the upper cervical spine (C1, C2 and C3), leading to a hypersensitivity state of the trigeminal pathway conveying sensory information for the face and much of the head. It is suggested that spinal manipulative therapy may stimulate neural inhibitory systems at different spinal cord levels because it might activate various central descending inhibitory pathways. It also activate the diffuse descending pain inhibitory system, whose neurons are located in the peri aqueductal grey matter. The disruption of pain-spasm-pain cycle is another proposed mechanism through which SMT could improve headache.

Migraine is the most common disorder affecting population world wide and possess a major health problem. Thirty-eight million adults in the United States are estimated to be migraine sufferers; of these, 91% experience migraine-associated disability. Pharmacological management is the first treatment option for migraneurs. However some patients do not tolerate acute and/or prophylactic medicine due to side effects or contra-indication due to co morbidity of other disease or due to a wish to avoid medication for other reason.The risk of medicine overdose due to frequent migraine attacks represent a major health hazard with direct or indirect cost concerns. The prevalence of medicine overuse headache is 1-2% in the general population which is about half of the population suffering from headache. Therefore to reduce medication side effects and overdose headache a safe and effective intervention will be a milestone in the treatment of migraine. Manual therapy can be an effective approach in treatment of migraine. Cervical spine manipulative therapy can be very effective and physical method to treat migraine headache.

 
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