| CTRI Number |
CTRI/2022/09/045170 [Registered on: 02/09/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of posterior neck and head muscle release technique on functional limitation and quality of life in cervicogenic vertigo patient |
|
Scientific Title of Study
|
Effect of Suboccipital release technique on functional limitation and quality of life in cervicogenic vertigo patient |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotiranjan Paltasingh |
| Designation |
MPT- Neurology |
| Affiliation |
SRM college of physiotherapy, Kattankulathur |
| Address |
Srm college of physiotherapy, SRM nagar, Chengalpattu, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8984302596 |
| Fax |
|
| Email |
jyotiranjanpaltasingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D Malarvizhi |
| Designation |
Professor |
| Affiliation |
SRM college of Physiotherapy |
| Address |
SRM college of physiotherapy Potheri,Kattankulathur campus, Chengalpattu, Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840090522 |
| Fax |
|
| Email |
malarvid@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Suresh J |
| Designation |
Assistant professor |
| Affiliation |
SRM college of Physiotherapy |
| Address |
SRM college of physiotherapy,Kattankulathur campus,Chengalpattu,Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9698642928 |
| Fax |
|
| Email |
sureshj@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research centre ,SRM nagar, potheri, chengalpattu, Kattankulathur |
|
|
Primary Sponsor
|
| Name |
Jyotiranjan Paltasingh |
| Address |
Chandapara,kanas,Puri, odisha |
| Type of Sponsor |
Other [Self funder ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM medical college hospital and research centre |
SRM nagar, potheri, chengalpattu, Kattankulathur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyotiranjan Paltasingh |
SRM medical college hospital and research centre |
ENT opd, room no 116,Kattankulathur campus, Chengalpattu, Tamilnadu -603203
Kancheepuram
TAMIL NADU |
8984302596
jyotiranjanpaltasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE (INSTITUTIONAL ETHICAL COMMITTEE) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sub occipital release technique |
The patient should be positioned supine on the table with the operator seated at the head of the table.
The finger pads should be placed over the suboccipital muscles bilaterally, just inferior to the superior nuchal line down to at approximately the level of C2. The patient’s head should lifted so the weight of it is supported upon the pads of the fingers.
Traction is then applied with the fingers in an anterior, lateral, and cephalad direction. The amount of traction that is used results in a force being applied to the tissues without producing significant movement of the structures.
This position is then held until the tissues relax, which may take anywhere from 15 seconds to a minute. 10-15 minutes per session,1 session per day,10 session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of cervicogenic vertigo accompanied with neck pain.
It occurs in episodic in nature which lasts for minutes to hours. |
|
| ExclusionCriteria |
| Details |
Vertigo not accompanied with neck pain.
Patient having Benign Paroxysmal Positional Vertigo.
Patient having recent history of fracture in cervical spine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of functional limitation of patient |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of quality of life of patient |
3 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
08/09/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervicogenic vertigo is characterized by Vertigo from cervical spine which is an unpleasant disturbance in spatial orientation. Vertigo affects both men and women but is about 2- 3 times more common in women than men. It has been associated with various comorbid conditions including depression and cardiovascular disease. Prevalence increases with age and varies depending on the underlying diagnosis. Based on a survey of the general population , the 1 year prevalence of vertigo is about 5% and an annual incidence of 1.4%. Dizziness including vertigo affects about 15% to over 20% of adults yearly. Hence there is a need for emphasis on early detection of vertigo and their appropriate intervention to be done as early as possible. Study design: Quasi-Experimental study , Sample size: 15 , No. of groups:1 Inclusion criteria: Age: 18-35 years, Gender: Male and female, Patients diagnosed with cervicogenic vertigo accompanied with neck pain, Episodic in nature lasting minutes to hours. Exclusion criteria: Cervicogenic vertigo not accompanied with neck pain, Patients having Benign paroxysmal positional vertigo, Recent history of fracture in cervical spine. Intervention: Sub occipital release Frequency with duration: 10-15minutes per session , 1 session per day for 10 days. Outcome measures: Dizziness handicap inventory scale, Vertigo symptoms scale Brief procedure: Based on the selection criteria 15 participants those who voluntarily give their acceptance to participate in the study will be selected and consent will be obtained from them. Prior to giving intervention, pre test assessment will be done. Then the participants will be given the intervention. A detailed treatment protocol pamphlet will be given to each participant for their better understanding and to gain maximum cooperation. Exercise will be continued for 10 days following which post assessment will be taken. Statistical analysis and result will be concluded based on the data obtained as a result of treatment protocol. |