| CTRI Number |
CTRI/2025/04/083824 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Sensorimotor Training Helps Reduce Headache Impact, Improve Neck Joint Accuracy, and Boost Neck Muscle Endurance in People with Cervicogenic Headaches |
|
Scientific Title of Study
|
The effectiveness of Sensorimotor Training on Headache Disability, Cervical Joint Position Error and Craniocervical Endurance in patients with Cervicogenic headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avrajit Sarkar |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
Department of faculty of physiotherapy, Sgt University Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9382327469 |
| Fax |
|
| Email |
avrajit10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anushree Rai |
| Designation |
Assistant professor |
| Affiliation |
SGT University |
| Address |
Department of faculty of physiotherapy, Sgt University Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
8937881164 |
| Fax |
|
| Email |
anushree.rai.21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avrajit Sarkar |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
Department of faculty of physiotherapy, Sgt University Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9382327469 |
| Fax |
|
| Email |
avrajit10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Shree Guru Govind Singh Tricentanary University, Budhera, Gurugram-Badli Road, Gurugram, Haryana, India. PIN CODE: 122505 |
|
|
Primary Sponsor
|
| Name |
Avrajir Sarkar |
| Address |
Faculty of physiotherapy, SGT University Chandu Budhera Village 122505 |
| 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 |
| Dr Avrajit Sarkar |
SGT Medical College And Hospital |
Department Of Physiotherapy, Basement Floor
Gurgaon
HARYANA |
9382327469
avrajit10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee, Faculty Of Physiotherapy, SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Sensorimotor Training along with conventional exercise |
Patient will perform cervical joint position sense training with lesser pointer and oculomotor control exercises (i.e eye tracking, gaze stability, eye and head co-ordination exercises). Each exercise will be performed 5 times a week for 4 weeks. Initially, the repetition of exreicse will be 3 times in each repetition for a total of 5 repetitions which will be followed by the same exercise protocol but eyes will be closed during progression along with the change in the direction of the neck movement. Along with these, conventional exercises will also be intervened. The conventional exercise that will be given to patients are cranio-cervical flexion training with pressure cuff by increasing the pressure of 20 mmHg initially and futher will be progressed by increasing the pressure upto 30 mmHg.Additionally, Cervical extensors exercise will also be intervened 3 times in each repetition for a total of 10 repetitons in total. The repetitions will be increased as per the progression and patients ability. |
| Comparator Agent |
Group 2- Conventional exercise |
The conventional exercise that will be given to patients are cranio-cervical flexion training with pressure cuff by increasing the pressure of 20 mmHg initially and futher will be progressed by increasing the pressure upto 30 mmHg.Additionally, Cervical extensors exercise will also be intervened 3 times in each repetition for a total of 10 repetitons in total. The repetitions will be increased as per the progression and patients ability. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with cervicogenic headache according to established diagnostic criteria, third edition of the International Classification of Headache Disorders (ICHD-3).
The ICHD-3 criteria for cervicogenic headache are as follows:
1. Any headache fulfilling criterion C
2. Clinical and/or imaging evidence of a lesion or disorder in the cervical spine or soft tissues of the neck that can cause headache
3. Evidence of cause of headache demonstrated by at least two of these:
3.1 Headache has developed in temporal relation to the appearance of the lesion or the onset of the cervical disorder
3.2 Headache has significantly improved or resolved in unison with improvement in or the resolution of the cervical lesion or disorder
3.3 Cervical range of motion is reduced, and provocative maneuvers may significantly worsen the headache
3.4 Headache is abolished following diagnostic blockade of a cervical structure or its nerve supply
4. Not better accounted for by another ICHD-3 diagnosis.
History of neck pain occurring for more than three months and joint position error of more than 3 in at least two out of four directions of neck movements (flexion, extension, left and right rotation) |
|
| ExclusionCriteria |
| Details |
1. Tension-type headaches and migraine
2. Internal carotid or vertebral artery dissection
3. Arnold-Chiari malformation
4. Herniated intervertebral disc
5. Intramedullary or extramedullary spinal tumor
6. Spinal nerve compression or tumor
7. Arteriovenous malformation
8. Neck-tongue syndrome
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache disability inventory, Cervical joint position error |
the data will be collected at baseline and after intervention given for a time period of 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| craniocervical endurance |
the data will be collected at baseline & after intervention given for a time period of 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
10/04/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Cervicogenic headache (CGH) is a chronic headache originating from the neck’s musculoskeletal structures, often triggered by neck movement. Its prevalence in the general population ranges from 0.17% to 4.1%, but accurate epidemiological data is limited due to varying diagnostic criteria. The condition arises from dysfunction in the upper cervical spine and is linked to the trigeminocervical nucleus, which transmits pain from the neck to the head. Sensorimotor disturbances, such as impaired neck mobility, altered motor control, and proprioceptive deficits, play a significant role in CGH. These disturbances affect balance, eye movement, and postural stability, as cervical afferents contribute to essential reflexes coordinating head, eye, and body movements. Sensorimotor training has emerged as a promising approach for CGH management, improving neck function and reducing pain. Physiotherapy, including exercise and spinal manual therapy, is also effective, especially in distinguishing CGH from migraines and tension-type headaches. Therapeutic exercise (TE) is particularly beneficial, as it reduces headache intensity, frequency, and disability with minimal side effects.The aim of the study was to find out the effect of sensorimotor training on headache disability, cervical
joint position sense, and craniocervical endurance in subjects diagnosed with
cervicogenic headache. |