| CTRI Number |
CTRI/2025/01/079053 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating cervicogenic Headaches in People with Upper Crossed Syndrome |
|
Scientific Title of Study
|
Assessing the occurrence of the Cervicogenic Headache in Upper Crossed Syndrome |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi R Nair |
| Designation |
PG Student |
| Affiliation |
Lovely Professional University |
| Address |
LPU OPD, 3rd block, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT) road, Near Chaheru, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9381781929 |
| Fax |
|
| Email |
vaishnavi.r.nair0721@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thiagarajan Subramanian |
| Designation |
Professor |
| Affiliation |
Lovely Professional University |
| Address |
Block 4, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT) road, Near Chaheru, Phagwara
Kapurthala
PUNJAB
144411
India |
| Phone |
9789247047 |
| Fax |
|
| Email |
strajanpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thiagarajan Subramanian |
| Designation |
Professor |
| Affiliation |
Lovely Professional University |
| Address |
Block 4, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT) road, Near Chaheru, Phagwara- 144411, Punjab, India
Kapurthala
PUNJAB
144411
India |
| Phone |
9789247047 |
| Fax |
|
| Email |
strajanpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University, jalandhar- Delhi, Grandtrunk (GT) road, Near chaheru, Phagwara-144411, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Vaishnavi . R .Nair |
| Address |
Room no 105, LPU OPD, 3rd block, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk(GT) road, Near Chaheru, Phagwara-144411, Punjab |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| VaishnaviRNair |
LOVELY PROFESSIONAL UNIVERSITY |
Room no.105, LPU OPD, 3rd block, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, Grand trunk road
Kapurthala
PUNJAB |
9381781929
vaishnavi.r.nair0721@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Upper Cross Syndrome |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female participants
Aged - 18-25 years
Headache triggered by neck movements, sustained or awkward neck postures
Ipsilateral neck, shoulder and arm pain
Unilateral head pain without side-shifts
• Restricted active neck ROM; neck stiffness
|
|
| ExclusionCriteria |
| Details |
Structural abnormalities such severe kyphosis or scoliosis were excluded.
Neuromuscular disorders
Malignancy
Any recent surgical intervention
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain Pressure Threshold
2.Cervical Flexion Rotation Test |
1. Baseline
2. Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Maximum Inspiratory Pressure
(MIP) Maximum Expiratory Pressure (MEP) |
1time |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
01/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vaishnavi.r.nair0721@gmail.com].
- For how long will this data be available start date provided 01-02-2025 and end date provided 31-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
All the 57 participants were given consent to voluntarily participate in this study. Each participant was aware about the objective of this study to find the cause for the problem and solution. The demographic characters Age, Gender, BMI, Waist hip Ration, Chest Hip Ratio, were measured prior to documenting the outcomes. .This study is going to be conducted using three outcome measures they are Pain Pressure Threshold, Cervical Flexion Rotation Test and Maximal inspiratory and expiratory pressure which are considered reliable and valid for assessing prevalence of Cervicogenic headache in Upper Cross Syndrome and show the relation between Cervicogenic headache and Upper Cross Syndrome. The algometers are the devices that quantify the amount of pressure needed to induce pain in a particular area.. The commonly included areas are upper trapezius, levator scapulae, pectoralis major and minor, scalene muscle and deep cervical flexors. Participants are made to be seated or in lying comfortably with good support for neck and back. Muscles being tested are relaxed. The algometer is placed on the trigger points with gentle pressure, gradually the pressure is increased in a controlled manner, until the participants reports any discomfort. Note the pressure reading with the baseline data. Secondly is the Cervical Flexion Rotation test this clinical examination assesses the cervical spine mobility with individuals suspected with CGH. Participants are made to be seated or in supine lying comfortably. The purpose of the test is explained to the participants with their consent.. Emphasizing that it assesses cervical spine mobility and its physical association with their headache symptom. A brief assessment of cervical spine ROM is noted, if any limitation is present during cervical rotation. Participants are asked to perform cervical flexion by lowering the chin towards their chest while keeping the shoulders relaxed. The degree of upper cervical rotation ROM in the position of maximum cervical flexion was measured using relative segmental motion of the head. Lastly the Maximal inspiratory and expiratory pressure is checked were the participant are instructed to secure the capsule sensing pressure device gauge and place their lips around the mouthpiece. Following that, the participant was told to exhale the residual air. The next step was to take three maximum inspiration breaths with a one-minute interval between each one. The participant was then required to perform maximum expiration three times, with a one-minute gap between each breath. These instructions ensured participant compliance with study requirements and consistent, accurate data collection. |