| CTRI Number |
CTRI/2018/12/016717 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
19/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of different exercises in the management of headache |
|
Scientific Title of Study
|
Effectiveness of Mobilization and Postural Correction in the Management of Cervicogenic Headache |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Rani |
| Designation |
Research Scholar |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, New Delhi-Rohtak-Sirsa Highway, Hisar.
Hisar
HARYANA
125 001
India |
| Phone |
09466758201 |
| Fax |
|
| Email |
monikarani802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Kulandaivelan |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology, |
| Address |
Dept of Physiotherapy, Guru Jambheshwar University of Science and Technology, NH10- New Delhi-Rohtak-Sirsa Road, Hisar.
Hisar
HARYANA
125 001
India |
| Phone |
09996003995 |
| Fax |
|
| Email |
tryhard2024@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
S Kulandaivelan |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology, |
| Address |
Dept of Physiotherapy, Guru Jambheshwar University of Science and Technology, NH10- New Delhi-Rohtak-Sirsa Road, Hisar.
HARYANA
125 001
India |
| Phone |
09996003995 |
| Fax |
|
| Email |
tryhard2024@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Monika Rani,
Research Scholar,
Department of Physiotherapy,
Guru Jambheshwar University of Science and Technology,
Hisar-125001. |
|
|
Primary Sponsor
|
| Name |
Monika Rani |
| Address |
Research Scholar, Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar- 125 001. |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Kulandaivelan S |
Health Center, Guru Jambheshwar University of Science and Technology |
Room No 4, Department of Physiotherapy (Ground Floor), Health Center, Guru Jambheshwar University of Science and Technology, Hisar.
Hisar
HARYANA |
9996003995
tryhard2024@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active control group |
Control group will be given education and self-management of cervicogenic headache as defined by McDonnell et al., 2005. They will receive reminder SMSs (three per week) for 4 weeks duration. |
| Intervention |
Neural mobilization group |
Participants will receive neural mobilization explained by Ferragut-Garcias et al., 2017. Total duration of single session will be 20-30 minutes. Frequency will be 3 sessions per week. Total duration will be 4 weeks. |
| Intervention |
Postural correction group |
Participants will receive specific postural exercises explained by Park et al., 2017; Bodes-Pardo et al., 2013; Ylinen et al., 2010. Total duration of single session will be 20-30 minutes. Frequency will be 3 sessions per week. Total duration will be 4 weeks. |
| Intervention |
Spinal mobilization group |
Participants will receive specific mobilization exercises explained by Malo-Urries et al., 2017; Dunning et al., 2016; Shin et al., 2014. Total duration of single session will be 20-30 minutes. Frequency will be 3 sessions per week. Total duration will be 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cervicogenic headache will be diagnosed through criteria developed by Sjaastad et al., 1998
|
|
| ExclusionCriteria |
| Details |
Any other form of headache including migraine
Corticosteroid use (at least 3 months in the last 12 months)
Vertebro basillar arterial insufficiency
Cervical spondylosis with radiating pain
Any neurological conditions (i.e) flaccidity or spasticity
Any cardiovascular disease (i.e) heart attack
Any chronic pulmonary conditions (i.e) COPD, Restrictive lung diseases
Any trauma or surgery in last 2 years
Any infections, fever in last 6 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Headache related disability (Headache impact test- HIT 6)
Neck related disability (Neck disability index)
Intensity, frequency and duration of headache (headache diary) |
Pre-intervention (baseline), Post-intervention (4th week),
Follow-up (8th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nothing |
- |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2019 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Headache including Cervicogenic headache is one of the common chronic disorder that leads to disability in the individual and causes great burden to society. Headache related research is scarce in India except few studies from Karnataka/Bangalore city specific. Very little work has been done on efficacy of physical therapy intervention on cervicogenic headache in India. Cervicogenic headache is musculoskeletal related problem which can be treated by physiotherapy interventions, Several studies indicated that physical therapy interventions might be an effective treatment approach for cervicogenic headache. Result of these studies indicated that manipulation can be an effective treatment for cervicogenic headache. Very few studies have been performed to evaluate the effect of mobilization and postural correction exercises on cervicogenic headache. Chronic adaptation of soft tissues over the time in cervicogenic headache may leads to neural tissue shortening which may be benefited by neural mobilizaton techniques. There is no study has been performed to evaluate the efficacy of neural mobilization as treatment strategy for cervicogenic headache. Therefore present study aims to fill this gap in research evidence by performing spinal mobilization, postural correction exercises and neural mobilzation techniques to find its efficacy on cervicogenic headache as well as to compare the efficacy of these approaches on cervicogenic headache management. |