| CTRI Number |
CTRI/2025/09/094540 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving chronic neck pain through action observation therapy and pain neuroscience education |
|
Scientific Title of Study
|
The effects of action observation therapy and pain neuroscience education in individuals with chronic neck pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Nain |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Department of Physiotherapy, E-Block, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7217640397 |
| Fax |
|
| Email |
nidhinain912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Verma |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Faculty room,Department of Physiotherapy, E-Block, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992822644 |
| Fax |
|
| Email |
Bhawna_pt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Nain |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Department of Physiotherapy, E-Block, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
7217640397 |
| Fax |
|
| Email |
nidhinain912@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Faculty room, E-Block, College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak, Haryana-124001, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Nidhi Nain |
Pt. B.D. Sharma, PGIMS |
Room no. 28, 29, 30,39, 42
Ortho OPD and Physiotherapy OPD, Physiotherapy Department, E-Block, College of Physiotherapy, Pt. B.D. Sharma, PGIMS
Rohtak
HARYANA |
7217640397
nidhinain912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics commitee |
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 |
| Intervention |
Pain Neuroscience Education and Action Observation therapy |
Pain Neuroscience Education will be delivered through PPT and Action Observation therapy will be given in form of video (11 minutes: 4 minutes of observing clips of exercise, followed by 3 minutes of rest and repetition of 4 minutes of video clip) at the end of the session.
There will be 4 sessions of both Pain Neuroscience Education and Action Observation therapy.
2 sessions twice a week for 2 weeks. |
| Comparator Agent |
Pain Neuroscience Education and Natural Landscape Observation |
Pain Neuroscience Education will be delivered through PPT and Natural Landscape Observation therapy (11 minutes: 4 minutes of video of natural landscape, followed by 3 minutes interval with completely black screen and another 4 minutes of video of different natural landscape) will be given in form of video at the end of the session.
There will be 4 sessions of both Pain Neuroscience Education and Natural Landscape Observation therapy.
2 sessions twice a week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Visual Analog Scale (VAS) score (range: 1-10) greater than 3 and less than 8 in the last 24 h
History of neck pain (at least 12 weeks and 3 days a week)
|
|
| ExclusionCriteria |
| Details |
Subjects with cervical fracture and subluxation
Subjects with vestibular pathology
Subjects with rheumatic autoimmune diseases
Subjects with severe cervical trauma (i.e. automobile accident that had affected the cervical area; whiplash)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Disability
Fear of movement
Pain catastrophizing
Sleep quality |
Day 0 (Pre-intervention)
After 2 weeks (Post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2025 |
| 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
|
This study aims to evaluate the effect of combining action observation therapy with pain neuroscience education in comparison to pain neuroscience education in individuals with chronic neck pain. A total of 30 subjects will be included in the study as per inclusion and exclusion criteria by using screening proforma. A comprehensive description of study will be given to participants and participants will be requested to sign an informed consent. Then subject will be randomly allocated to each group. In Group A (Experimental Group), Pain Neuroscience Education will be delivered through PPT and Action Observation therapy will be given in the form of video at the end of the session. Participants will be asked to observe a video of a person performing specific therapeutic neck exercises. In Group B (Control Group), Pain Neuroscience Education will be delivered through PPT and Natural Landscape Observation therapy will be given at the end of the session. Participants will be asked to observe a video of natural landscapes. Outcomes measures will be taken pre and post intervention. |