| CTRI Number |
CTRI/2020/10/028584 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of oculomotor exercises with conventional treatment in neck pain patients with associated visual complaints |
|
Scientific Title of Study
|
Effect of Oculomotor exercises with conventional treatment on Neck pain, Disability and Gaze stability in non specific chronic neck pain patients with associated visual complaints |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr.D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy 1st cabin, 3rd floor, Dr.D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr.D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy 1st cabin, 3rd floor, Dr.D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jidnyasa Thakur |
| Designation |
PG Student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
PG-2 Classroom, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9767688221 |
| Fax |
|
| Email |
jidnyasat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil Colege of Physiotherapy,Pimpri,Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Department of Kinesiotherapy 1st cabin, 3rd floor, Dr.D.Y. Patil
College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India
|
| 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 |
| Amita Aggarwal |
Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune |
Department of Kinesiotherapy, 1st cabin, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Plot no. BGP/190, Pimpri-Chinchwad, Maharashtra 411018 Pune.
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional treatment for neck pain. |
Sternocledomastoid and Scaleni muscles stretching (30 seconds hold for stretch,total 3 repetitions) and the isometric exercises would be given for 5 reps with 5 seconds hold for week 1, then progressing to 5 repetitions with 10 seconds hold for week 2 and later to 10 repetitions with 10 seconds hold for week 3.
the exercises would be given 3 alternate days a week for 3 weeks. |
| Comparator Agent |
Oculomotor Exercises |
Oculomotor exercises will be given for 30 seconds in week one. Then for 1-2 mins in week 2 and later for 5 mins in week 3. Repititions completed in given time for each week will be recorded.
The exercises would be given for 3 alternate days per week for 3 weeks. (Total 9 sessions) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals with chronic neck pain
2 Individuals with associated visual complaints according to the visual complaints index
3 Neck disability scores of minimum 5 points or 10% points |
|
| ExclusionCriteria |
| Details |
1 Recent cervical fracture
2 Individuals with whiplash injury
3 Individuals diagnosed with vestibular disorders
4 Individuals with cervical neuropathy
Individuals with cervical radiculopathy
5 History of neck/ eye surgery
6 Recent trauma
7 Malignancy |
|
|
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 |
Visual Analogue Scale (VAS)
Neck Disability Index (NDI)
Dynamic visual acuity test (DVA) |
On the first day and at the end of three weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE:- EFFECT OF OCULOMOTOR EXERCISES WITH CONVENTIONAL TREATMENT ON NECK PAIN, DISABILITY AND GAZE STABILITY IN NON SPECIFIC CHRONIC NECK PAIN PATIENTS WITH ASSOCIATED VISUAL COMPLAINTS. OBJECTIVES:- To study the added effect of oculomotor exercises with conventional treatment on pain in non specific chronic neck pain patients with associated visual complaints. To study the added effect of oculomotor exercises with conventional treatment on disability in non specific chronic neck pain patients with associated visual complaints. To study the added effect of oculomotor exercises with conventional treatment on gaze stability in non specific chronic neck pain patients with associated visual complaints. METHODOLOGY:- Group A:- Conventional treatment would be given which would include stretching and isometric exercises. Group B:- Conventional treatment and Oculomotor exercises. Treatment would be given for 3 days a week for 3 weeks. A follow up would be taken one week after the completion of 9 sessions. |