| CTRI Number |
CTRI/2024/10/075498 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| 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
|
Comparison Of Two Different Physiotherapy Interventions As Adjunct Therapies For Patients With Non-Specific Chronic Neck Pain |
|
Scientific Title of Study
|
Comparison Of Whole-Body Vibration And Sensorimotor Training As Adjunct Therapies For Patients With Non-Specific Chronic Neck Pain: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zubia Veqar |
| Designation |
Honorary Director and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No. 202, 2nd Floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025, India
South
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zubia Veqar |
| Designation |
Honorary Director and Professor |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No. 202, 2nd Floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025, India
DELHI
110025
India |
| Phone |
9958993486 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sara Nishat |
| Designation |
Student |
| Affiliation |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Room No. 207, 2nd Floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025, India
South
DELHI
110025
India |
| Phone |
9582635717 |
| Fax |
|
| Email |
saranishat2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Okhla, New Delhi,India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi-110025, India |
| Type of Sponsor |
Other [Central 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 |
| Dr Zubia Veqar |
Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
Physiotherapy OPD, Room No-08, Ground Floor, Centre For Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Md Ali Jauhar Marg, Okhla, New Delhi 110025, India
South
DELHI |
9958993486
veqar.zubia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Total duration of one session will be 30 minutes.Protocol will be given thrice a week for four weeks. There will be 12 sessions in total.Conventional physiotherapy consists of hot pack application at cervical region for 10 minutes, application of transcutaneous electrical nerve stimulation at cervical region for 10 minutes and performance of a specific therapeutic exercise program consisting of isometric exercises, strengthening exercises. |
| Intervention |
Sensorimotor training plus Conventional Physiotherapy |
Total duration of one session will be 60 minutes. Protocol will be given thrice a week for four weeks. There will be 12 sessions in total. Sensorimotor training consists of the performance of cervical joint position and movement sense training using laser pointer method, oculomotor exercises (eye tracking, eye head coordination and gaze stability exercises) and balance training. In conventional Physiotherapy, Hot pack and TENS will be given and some therapeutic exercises will be performed. |
| Intervention |
Whole-body Vibration Training Plus Conventional Physiotherapy |
Total duration of one session will be 50 minutes. Protocol will be given thrice a week for four weeks. There will be 12 sessions in total. Whole-body vibration training will consist of training on a vibration platform. Total duration of vibration training will be - 20 minutes, 12 minutes of active training and 8 minutes of rest to avoid fatigue. In the first week i.e., first three sessions, the participants will train while standing on both legs on the device surface with slightly bent knees at approximately 30°. As from the second week of intervention, the training will progress to include more progressive activities on the device such as tandem stance, single-leg stance (eyes opened or closed), throwing or catching a ball while standing on a single leg etc. In Conventional physiotherapy, Hot pack and TENS will be given and some therapeutic exercises will be performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Non-specific chronic neck pain since 3 months or longer for less than 7 years
Numeric Pain Rating Scale (NPRS) 2-6
Neck Disability Index score- between 5-24
Patients who have a working knowledge of English
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Presence of probable contraindications to vibrations- e.g. pregnancy or recent medical procedure
Uncontrolled blood pressure or diabetes
History of cervical spine surgery
History of head/neck trauma
Symptoms of cervical radiculopathy/stenosis
Vertebrobasilar insufficiency, vertigo or dizziness from ear or brain disorders eg, BPPV or any other vestibular condition
History of whiplash-associated disorders
Signs of rheumatic diseases
Musculoskeletal or neurological conditions that might affect balance or proprioception
Pain reported in the lumbar, hip, knee or ankle at the same time
Advanced osteoporosis, pacemaker, arrhythmias
Malignancy, infection, or inflammatory disorders
Undergoing concurrent treatment for neck pain
Difficulty understanding or communicating
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain intensity
Pain Pressure Threshold
Cervical Proprioception |
At baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cervical extensor and flexor muscle endurance testing
Balance Measures including static balance, reaction time, proprioception, COP sway, COP range, coordination and multidirectional stability
Neck Function and Disability |
At baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Patients will be recruited from Centre For Physiotherapy and Rehabilitation Sciences. Pateints will be required to sign the consent form explaining their rights as research subjects. All the identifying information on the consent form and demographic data shall be confidential. The initial assessment of the patient will include demographic data, anthropometric characteristics and screening for non-specific chronic neck pain. Baselines assessment will include measurements for neck pain intensity using NPRS, pain pressure threshold using pressure algometer, cervical proprioception using laser pointer mounted onto a lightweight headband, cervical muscle endurance testing using the neck flexor and extensor muscle testing, balance measures using the Pedalosensamove Balance Test and neck function and disability using the neck disability index will be taken. Intervention will be given thrice a week for four weeks. After which post intervention assessment will be taken again. |