| 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
|
|
|
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
|
|
|
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. |