| CTRI Number |
CTRI/2024/05/068186 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| 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
|
Efficacy of different exercises protocol in management of Cervical Spondylosis |
|
Scientific Title of Study
|
Efficacy of Sensorimotor exercises and Motor control exercises in management of Cervical Spondylosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPIKA |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
GURU JAMBHESWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
ROOM NO. 4, GROUND FLOOR, DEPARTMENT OF
PHYSIOTHERAPY GURU JAMBHESWAR UNIVERSITY OF
SCIENCE AND TECHNOLOGY,HISAR
Hisar
HARYANA
125001
India |
| Phone |
9466423740 |
| Fax |
|
| Email |
deepikalakhwan001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEEPIKA |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
GURU JAMBHESWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
ROOM NO. 4, GROUND FLOOR, DEPARTMENT OF
PHYSIOTHERAPY GURU JAMBHESWAR UNIVERSITY OF
SCIENCE AND TECHNOLOGY,HISAR
Hisar
HARYANA
125001
India |
| Phone |
9466423740 |
| Fax |
|
| Email |
deepikalakhwan001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROFSSOR SHABNAM JOSHI |
| Designation |
PROFESSOR |
| Affiliation |
GURU JAMBHESWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY |
| Address |
ROOM NO. 6, DEPARTMENT OF PHYSIOTHERAPY, GURU JAMBHESWAR UNIVERSITY OF SCIENCE AND
TECHNOLOGY, HISAR
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| GURU JAMBHESWAR
UNIVERSITY OF SCIENCE AND TECHNOLOGY,HISAR(125001), HARYANA,INDIA |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY GURU JAMBHESWAR
UNIVERSITY OF SCIENCE AND TECHNOLOGY, HISAR(125001),HARYANA, INDIA |
| Type of Sponsor |
Other [UNIVERSITY] |
|
|
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 |
| DEEPIKA |
GURU JAMBHESWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY, HISAR |
ROOM NO. 4,
GROUND FLOOR,
DEPARTMENT OF
PHYSIOTHERAPY,
GURU JAMBHESWAR
UNIVERSITY OF
SCIENCE AND
TECHNOLOGY,
HISAR, HARYANA
Hisar
HARYANA |
9466423740
deepikalakhwan001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of Physiotherapy,Institutional ethical committee, Guru Jambheshwar University of Science and Technology, Hisar(125001) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M192||Secondary osteoarthritis of otherjoints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Control Group
|
Group A It includes neck isometric exercise, manual traction and hot pack will be given three times a week. |
| Comparator Agent |
Group B: Motor control exercises |
Group B It includes the motor control exercises will be given in addition to conventional treatment three times a week. |
| Comparator Agent |
Group C: Sensorimotor exercises |
Group C It includes sensorimotor exercises will be given in addition to conventional treatment for three times a week. |
| Comparator Agent |
Group D: Combination sensorimotor exercises and motor control exercises |
Group D It includes combination of sensorimotor exercises and motor control exercises will be given in addition to conventional treatment three times a week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with neck pain
2. Subjects with cervical spondylosis, diagnosed on the basis of clinical assessment and diagnostic imaging
3. Subjects with positive Spurling’s test and Distraction test
4. Age between 40 to 60 years
5. Both males and females
6. Subjects with or without radiculopathy
|
|
| ExclusionCriteria |
| Details |
1. History of neck surgery over the past year
2. History of ankylosing spondylitis
3. History of whiplash injury
4. History of tumors
5. History of neurological conditions
6. History of osteoporosis
7. Subjects who are not willing to participate in the study
8. Any other condition where intervention may adversely affect the individual
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRESSURE PAIN THRESHOLD
NECK DISABILITY
CERVICAL RANGE OF MOTION |
BASELINE,AFTER 6 WEEKS, FOLLOW UP AFTER 2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CERVICAL PROPRIOCEPTION DEEP NECK FLEXORS STRENGTH AND ENDURANCE |
BASELINE, AFTER 6 WEEKS, FOLLOW UP AFTER 2
WEEKS |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/06/2024 |
| 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="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [If required].
- For how long will this data be available start date provided 04-02-2026 and end date provided 04-05-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Efficacy of Sensorimotor exercises and Motor control exercises in management of Cervical Spondylosis Subjects will be included from the various hospitals of Hisar and from the Departmental OPD, GJUST, Hisar after taking the written informed consent. All the participants will be screened according to the inclusion and exclusion criteria of the study. The explanation of the procedure will be given to all the participants included in the study. After inclusion all subjects will be randomly divided into four different groups. The treatment will be given thrice a week for a total duration of six weeks in all four groups. The assessment will be performed at baseline and after completion of the treatment duration and after the follow up of two weeks |