| CTRI Number |
CTRI/2025/07/090728 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
"Comparing Yogic Eye Exercises and Oculomotor Exercises for People with Neck Pain and Vision Problems" |
|
Scientific Title of Study
|
Comparison of yogic eye versus oculomotor exercises in non-specific chronic neck pain patients with visual complaints. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Thakur |
| Designation |
PG Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala. |
| Address |
Ground Floor Physiotherapy Department, MMDU, Mullana, Ambala.
Beatle leaf near Bhudian, Mullana, Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
08219768633 |
| Fax |
|
| Email |
tsneha648@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala. |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala.
133207
First floor Physiotherapy Department, MMDU, Mullana, Ambala.
133207
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita.aggarwal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala. |
| Address |
MMIPR, MMDU, Mullana, Ambala.
133207.
First floor Physiotherapy Department, MMDU, Mullana, Ambala.
133207
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita.aggarwal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute (Deeemed to be University), Mulloana, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Sneha Thakur |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana, Ambala, Haryana, India, 133207 |
| 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 Sneha Thakur |
MMIPR Physiotherapy OPD |
Ground Floor, MMIPR, Maharishi Markandeshwar Deemed to Be university, Mullana, Ambala.
Ambala
HARYANA |
08219768633
tsneha648@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical & Research Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oculomotor eye exercises with conventional exercises for non-specific chronic neck pain |
Group B (Oculomotor Eye Exercise group) includes the conventional protocol along with oculomotor exercises which include saccadic eye movement, smooth pursuit exercise, Adaptation X1 exercise, and Adaptation X2 exercise. The time duration for each exercise will be week 1: 30 s, week 2: 1 min, week 3: 2 min. |
| Intervention |
Yogic eye exercises with conventional exercises for non- specific chronic neck pain |
Group A (Yogic Eye exercises group) includes of 8 steps: palming, blinking, sideways viewing, front and sideways viewing, rotational viewing, up and down viewing, preliminary nose-tip gazing, near and distant viewing etc. Each step will be performed for 5 minutes per cycle. After the eye exercises, the participants will practice the Shavasana (corpse pose) for 20 minutes to relax their eyes stretching of anterior scalene and sternocleidomastoid muscle (three repetitions each for 30 s hold), neck isometric exercises for flexion, extension, side flexion and rotation will be given for week 1: 5 s hold and 5 repetitions, week 2: 10 s hold and 5 repetitions, week 3: 10 s hold and 10 repetitions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-34 years.
Both females and males
Patients having neck pain with visual complaints
Individuals who agree to participate
|
|
| ExclusionCriteria |
| Details |
Other ocular conditions
Surgical history (e.g. cataract)
Individuals with any eye pathological conditions, eye infections, conjunctivitis, optic neuropathy, and optic neuritis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index (NDI)
Visual Complaints Index (VCI)
Gaze Stability Test (GST)
• Neck ROM
|
Baseline, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
Baseline, 4th week |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
12/07/2025 |
| 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 - NO
|
|
Brief Summary
|
The conservative management given to the groups will be as follows and intervention duration for both the groups will be three weeks which consisted of nine treatment sessions, three days every week. Progression in the exercises will be given on weekly basis. Group A (Yogic Eye exercises group) includes of 8 steps: palming, blinking, sideways viewing, front and sideways viewing, rotational viewing, up and down viewing, preliminary nose-tip gazing, near and distant viewing etc. Each step will be performed for 5 minutes per cycle. After the eye exercises, the participants will practice the Shavasana (corpse pose) for 20 minutes to relax their eyes stretching of anterior scalene and sternocleidomastoid muscle (three repetitions each for 30 s hold), neck isometric exercises for flexion, extension, side flexion and rotation will be given for week 1: 5 s hold and 5 repetitions, week 2: 10 s hold and 5 repetitions, week 3: 10 s hold and 10 repetitions. Group B (Oculomotor Eye Exercise group) includes the conventional protocol along with oculomotor exercises which include saccadic eye movement, smooth pursuit exercise, Adaptation X1 exercise, and Adaptation X2 exercise. The time duration for each exercise will be week 1: 30 s, week 2: 1 min, week 3: 2 min.5
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