| CTRI Number |
CTRI/2020/05/024968 [Registered on: 01/05/2020] Trial Registered Prospectively |
| Last Modified On: |
24/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Physiotherapy treatment for patients having Cervicogenic Headache using Type IV LASER and Myofascial Release. |
|
Scientific Title of Study
|
Physiotherapy intervention for treating cervicogenic headache by comparing effect of TYPE IV LASER and Myofascial Release in Middle aged population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Thakur |
| Designation |
MPT(Musculoskeletal)Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy,Mullana,Haryana |
| Address |
Maharishi Markandeshwar(Deemed to be) University,Mullana,Haryana
Maharishi Markandeshwar Institute of Physiotherapy,Mullana,Haryana
Ambala
HARYANA
133207
India |
| Phone |
9815726401 |
| Fax |
|
| Email |
swatithakur0003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy,Mullana, Haryana |
| Address |
Maharishi Markandeshwar University,Mullana,Haryana
Maharishi Markandeshwar Institute of Physiotherapy,Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumya Kothiyal |
| Designation |
Assisstant Professor |
| Affiliation |
MMIPR,MMU |
| Address |
Maharishi Markandeshwar University,Mullana, Ambala, Haryana
Maharishi Markandeshwar University,Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7906968626 |
| Fax |
|
| Email |
saumya.kothiyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar deemed to be University, Mullana, Ambala, Haryana. |
|
|
Primary Sponsor
|
| Name |
MMIPR |
| Address |
Mullana,Ambala,Haryana,133207 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Swati Thakur |
Maharishi Markandeshwar Institiute of Physiotherapy,Mullana |
Maharishi Markandeshwar(Deemed to be)University,Mullana
Ambala
HARYANA |
9815726401
swatithakur0003@gmail.com |
|
|
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: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myofascial Release |
Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in direct and indirect approaches) intending to decrease pain, restore optimized length and facilitate the release of fascial restrictions caused by injury, stress and repetitive use.
There will be 10 therapy session given for 3 successive weeks. |
| Intervention |
Type IV LASER |
Low Level Laser therapy is the application of light to a Biologic System to promote Tissue Regeneration, reduce inflammation and relieve pain.It has proven to impart analgesic, Anti-Inflammatory and bio stimulating effects.
The dosage will vary according to pain if acute pain then 6J/cm square and if chronic pain then 12J/cm square over treatment area.Frequency of dosage will be continuous.The device will automatically calculate the treatment time. 5-10 treatments will be given over a periods of 3 Weeks each treatment to be given every alternate day |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants with cervicogenic headache.
2.Middle aged population.
|
|
| ExclusionCriteria |
| Details |
1.Any injury in the neck region. 2.Pacemakers
3.Pregnancy
4.Vertigo
5.Epileptic Seizures
6.Cancer
7.Diabetes
|
|
|
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 |
| Algometer |
2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sphygmomanometer |
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BACKGROUND: Cervicogenic Headache is referred pain perceived in the head from a source in the neck.It is associated with cervical myofascial pain sources such as myofascial trigger points,frequent and infrequent episodic tension type headache associated with pericranial tenderness and headaches caused by a disorder of the cervical spine and its component bony, disc or soft tissue elements. Purpose: To check effectiveness of Type IV LASER and Myofascial Release in improving the quality of life and reducing the impacts following cervicogenic headache.
Methods:The procedure will be explained to the selected participants fulfiiling the inclusion and exclusion criteria and after the consent has been obtained from the participants they will be divided into two groups Group A and Group B respectively as patients receiving myofascial release in Group A and Type IV LASER in Group B. |