| CTRI Number |
CTRI/2025/02/080849 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| 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
|
A Study on the Combined Effects of Neck Traction, Specific Stretching Exercises with Muscle Release Technique in the patients having Cervicogenic Headache |
|
Scientific Title of Study
|
Effectiveness of Cervical Traction and Proprioceptive Neuromuscular Facilitation in Combination with Graston Technique in Patients with Cervicogenic Headache: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India
Hisar
HARYANA
125001
India |
| Phone |
9319509603 |
| Fax |
|
| Email |
nehasheoran19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta Boora |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta Boora |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neha MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Haryana
125001
India
|
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar Haryana India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Mamta Boora |
Department of Physiotherapy Guru Jambheshwar University |
Room number 04 Department of Physiotherapy OPD Guru Jambheshwar University of Science and Technology
Hisar
Haryana
Hisar
HARYANA |
8683810061
mamtaboora50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJU&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients in thisgroup will be given Graston Technique and hot pack for 3 sessions per week for 4 weeks. |
| Intervention |
Graston Technique with Cervical Traction and hot pack |
Patients in this group will be given Graston Technique with Cervical Traction and hot pack for 3 sessions per week for 4 weeks. |
| Intervention |
Graston Technique with Proprioceptive Neuromuscular Facilitation and hot pack |
Patients in this group will be given Graston Technique with Proprioceptive Neuromuscular Facilitation and hot pack for 3 sessions per week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. 20-35 years of age.
2. History of CGH more than 3 months at Baseline, more than 5 days of CGH per month
3. Cervicogenic headache (CGH) intensity more than 3
4. Cervical spine dysfunction (cervical joint tenderness and/or restricted segmental
5. Clear temporal sequence linking the source of CGH to the neck: headache preceded by neck pain,
stiffness, movement and/or awkward postures
6. Independent ambulation |
|
| ExclusionCriteria |
| Details |
1. Already had participated in a regular exercise program for the previous three months and received
some medical treatment.
2. Orthopedic problems like fractures, acute neck injury, tumor, degenerative disease, cervical
surgery.
3. Uncooperative subject.
4. Being older than 35 years
5. Headache followed by migraine.
6.Vertigo
7. Dizziness
8. cardiovascular disease (e.g., Stroke, hypertension or hypotension, Ischemic attack,
9. Neurological conditions (e.g., Parkinsons disease, Seizures, Multiple sclerosis).
10. Any psychological disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck disability index
Numeric Pain Rating Scale
Headache Impact Test-6
Headache Frequency |
The outcome will be assessed for 2 times which is at the baseline and after the 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Manual Muscle Testing
|
The outcome will be assessed for 2 times which is at the baseline and after the 4 weeks |
| Cervical Flexion Rotation Test |
The outcome will be assessed for 2 times which is at the baseline and after the 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized controlled trial with a duration of 4 weeks and involving 48 patients that will be divided into three groups by lottery method. Intervention for first group includes Graston technique with cervical traction and hot pack, intervention for second group is Graston technique with proprioceptive neuromuscular facilitation and hot pack and control group will be given Graston technique and hot pack. Firstly, the patients will be informed about the study, and informed consent will be taken from them. Before beginning the treatment each patient’s demographic data including age, gender, weight and height will be gathered as a baseline data. Pre-intervention measurements of outcome variables including Numeric pain rating scale (NPRS), Neck disability index (NDI), Headache frequency, Headache impact test, Manual muscle testing (MMT) and Cervical flexion rotation test (CFRT) will be taken. Intervention will be given for 4 weeks and then the post-intervention data of all the outcome variables will be taken. |