| CTRI Number |
CTRI/2024/11/076143 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| 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
|
A study to compare the effects of Eye Cervical Re-Education Program (ECRP) with Conventional Treatment in Cervicogenic Headache patients. |
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Scientific Title of Study
|
Comparing the efficacy of Eye Cervical Re-Education Program (ECRP) with Conventional Therapy in Cervicogenic Headache patients: A Comparative study |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Sinha |
| Designation |
MPT Musculoskeletal student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Physiotherapy Department, Lecture Room 1, Third floor.
Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar, Delhi-110092
East DELHI 110092 India |
| Phone |
7291099453 |
| Fax |
|
| Email |
sinharadhika9826@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prerna Mohan Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
BPT Physiotherapy Department, Faculty Room, Second floor.
Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar, Delhi-110092
East DELHI 110092 India |
| Phone |
9999456988 |
| Fax |
|
| Email |
prernasaxena.88@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Radhika Sinha |
| Designation |
MPT Musculoskeletal student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Physiotherapy Department, Lecture Room 1, Third floor.
Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar, Delhi-110092
East DELHI 110092 India |
| Phone |
110092 |
| Fax |
|
| Email |
sinharadhika9826@gmail.com |
|
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Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy, Karkardooma, Anand Vihar. Delhi - 110092, India |
|
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Primary Sponsor
|
| Name |
Radhika Sinha |
| Address |
Amar Jyoti Institute of Physiotherapy, Karkardooma. Delhi - 110092 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Radhika Sinha PT |
Amar Jyoti Institute of Physiotherapy |
Amar Jyoti Institute of Physiotherapy Karkardooma Delhi - 110092 East DELHI |
7291099453
sinharadhika9826@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board-Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M530||Cervicocranial syndrome, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy or Control Group |
It will include the following:
1. Hot pack - 15 minutes
2. IFT - 15 minutes
3. Craniocervical Flexion (CCF) Exercise - This is done by lying down on the back with a rolled towel behind the neck. A nodding motion will be made with neck and head and hold for 10 seconds.
2. Flexion and Extension Exercise - In a sitting or standing position, the chin was brought to the chest slowly and held for 30 seconds for a gentle stretch to the back of the neck. Next, the head is moved back so that the eyes are focused on the ceiling to stretch the front neck muscles. This position is to be held for 30 seconds.
5. Rotation Exercise - This is done by standing or sitting in an erect position as the head turning to the right, looking over the shoulder. This positioning is to be held for 30 seconds.
6. Lateral Flexion Exercise - This is done by standing or sitting in an erect position as the head turning to the right, looking over the shoulder. This positioning is to be hold for 30 seconds and return to the starting position. The procedure is repeated on the left side.
7. Chin tuck Exercise - While in a standing or sitting position, gently move the shoulders backward as the chin is tucked down towards the chest. Remain forward facing and hold the position for 10 seconds.
8. Shoulder Blade Exercise - This is done while sitting or standing with hips straight, not leaning forward or backward. Slowly move the shoulders backwards and gently thrust the chest outwards and hold the position for five seconds.
9. Back strengthening Exercise - During back strengthening exercise, one lie on stomach with face down to floor. This is followed by deep inhalation and exhalation several times. Then prop the upper body onto elbows and hold the position for up to two minutes. |
| Intervention |
Eye Cervical Re-Education Program |
1. Hot pack - 15 minutes
2. IFT - 15 minutes
ECRP includes 10 exercises:
The patient will be placed in the supine position, with the physiotherapist seated at the height of the head.
1. Without moving the head, analytical exercises on the maximum amplitude of ocular movement towards the right, left, front, and feet were actively performed. The exercise will be repeated 3 times, first with the eyes open and then with closed eyes.
2. The physiotherapist will perform a passive mobilization of the cervical spine in rotation and flexo-extension, while the patient maintained the eyes at a fixed point located in the vertical direction. After memorizing this point, the exercise will be repeated with eyes closed.
The ocular mobility is excluded with opaque glasses that exclusively allowed the foveal vision.
3. Analytical exercises on cervical mobility were actively performed. The goal is to keep the gaze on a target as far as possible in each of the directions.
Each movement is repeated 3 times.
4. The patient follows with his eyes a complex geometric path or a graphic painted on the wall.
5.The patient fixed his gaze on a target on the wall, while the physiotherapist will destabilize the trunk in all directions in a combined manner.
6. The patient is placed in front of a mirror. After memorizing this position, he have to make movements with his eyes closed (flexo-extension, rotations, and lateral-flexions). Without opening his eyes, the patient should try to return to the starting position. This exercise is repeated 10 times.
7. This exercise is the same as the previous exercise except the physiotherapist will destabilise the patient.
Finally, we stimulate eye and neck movement coordination. The patient continued to sit on the stool, in this case, without the glasses.
8. The physiotherapist will stand in front of the patient with an object in his hand. The patient fixed his eyes on this object, which will be directed by the physiotherapist with the intention of reaching the maximum amplitude in each of the movements. The duration of this exercise is one minute, and it is repeated twice.
9. The physiotherapist will stand behind the patient. The subject will move in a requested direction and, in turn, the physiotherapist will offer manual resistance to the movement. The duration is 2 minutes.
10. Exercise 9 will be repeated; however, instead of offering manual resistance, the physiotherapist will perform soft imbalances on the patients head. The duration is two minutes. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
A. Diagnosed Cervicogenic headache patients as per Internation Headache Society under International Criteria for Headache Disorders - 3.
B. Patients who can understand and read spoken English.
|
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| ExclusionCriteria |
| Details |
A. Patients with other primary headaches (Migraine, Tension-type Headache).
B. Patients exhibiting any red flags (i.e., tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.).
C. A diagnosis of cervical spinal stenosis.
D. Patients having a known history of musculoskeletal soft tissue injury or surgery in the last 6 months.
E. History of congenital musculoskeletal/neurological disorders such as epiphyseal plate disturbance, and multiple sclerosis.
F. History of any psychological disorders such as seizures, or schizophrenia.
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Cervical Joint Position Error - Active movement angle reproduction test in which the difference between the reference point position and the position produced by the subject is called Joint Position Error.
2. Cervical Range of Motion
3. Verbal rating Scale
4. Headache Disability Index |
Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical Range of Motion - Flexion, extension, left and right rotations, left and right lateral flexion |
Baseline values will be taken before the start of the treatment, and post-treatment values will be taken after the completion of the treatment, that is, after a period of four weeks, after the patient has taken 12 sessions of the treatment. |
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Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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 1 |
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Date of First Enrollment (India)
|
10/11/2024 |
| 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="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
IntroductionCervicogenic headache (CGH) is a condition characterized by unilateral pain originating from the neck, often triggered by head and neck movements. The condition is frequently misdiagnosed as migraines or tension-type headaches due to overlapping symptoms. Reduced neck flexibility and proprioceptive deficits are common in CGH, which can further affect cervical sensorimotor control. Proprioception impairment may lead to dysfunctional motor patterns, increasing the risk of injury and chronic pain. The Eye-Cervical Re-education Program (ECRP), a proprioceptive training program, has been used in managing neck pain, but its effectiveness in treating CGH is not well established. This study aims to evaluate the efficacy of ECRP compared to conventional physiotherapy for reducing pain, improving range of motion (ROM), and enhancing quality of life in CGH patients. Need of the StudyCervicogenic headache is a prevalent condition in physiotherapy clinics, with most treatments focusing on flexibility and strengthening. However, research indicates that proprioception deficits are significant contributors to CGH. Despite this, proprioceptive training, particularly through programs like ECRP, has been poorly evaluated for its effectiveness in treating CGH. Given its potential in addressing maladaptive changes in cervical structures, this study seeks to determine whether ECRP can provide superior outcomes compared to conventional physiotherapy interventions in CGH patients. MethodologyStudy Design: This is an experimental study with a pre-post control design. Study Population: Cervicogenic headache patients aged 20-50 years. Sample Size: 42 participants, divided into two groups of 21 each, calculated using G power software. Groups: Group A: ECRP group (Hot pack, Interferential Therapy (IFT), ECRP training). Group B: Conventional group (Hot pack, IFT, conventional exercises). Randomization: Chit method. Study Setting: Outpatient Department (OPD) of Amar Jyoti Institute of Physiotherapy. Inclusion Criteria1. Diagnosed CGH patients based on International Classification of Headache Disorders (ICHD-3) criteria.2. Age range 20-50 years, both genders.3. English-speaking patients.Exclusion Criteria1. Patients with primary headaches (e.g., migraines).2. Presence of red flags (e.g., tumors, fractures, RA, or high blood pressure).3. History of recent surgery, congenital disorders, or psychological conditions.Outcome MeasuresPhysical Function: 1. Verbal Rating Scale (VRS): Measures pain intensity from 0-4 based on descriptive adjectives. 2. Cervical Spine ROM: Measured using a digital inclinometer for cervical flexion, extension, and rotation. 3. Cervical Joint Position Error (JPE): Measures proprioceptive accuracy during head movement using an inclinometer. Quality of Life: Headache Disability Inventory (HDI): A 25-item scale assessing the functional and emotional impacts of headaches on daily life. ProcedureAfter ethical approval from the Amar Jyoti Institute Review Board, patients will be screened and randomized into two groups. Both groups will receive standard treatment, including a hot pack and IFT, but Group A will undergo ECRP, while Group B will follow conventional exercises. Pre- and post-assessments of pain, ROM, cervical proprioception, and quality of life will be conducted. Data will be collected and analyzed using SPSS 27.0. InterventionsGroup A (ECRP Group): 1. Hot pack and IFT (15 minutes each). 2. ECRP includes 10 proprioceptive exercises targeting cervical-eye coordination, such as head repositioning and gaze stability exercises. Group B (Conventional Training Group): 1. Hot pack and IFT (15 minutes each). 2. Conventional exercises focus on craniocervical flexion, flexion-extension, and neck strengthening exercises, targeting overall neck flexibility and strength. Data AnalysisData will be entered into Microsoft Excel and analyzed using SPSS software (version 27.0). Descriptive statistics will be used to assess demographics, and comparative analyses will evaluate the effectiveness of both interventions in reducing pain and improving function and quality of life. |