| CTRI Number |
CTRI/2025/09/094867 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Development of pain science education content for individuals with chronic neck pain in India |
|
Scientific Title of Study
|
Development and feasibility of a culturally adapted pain science education content for chronic neck pain in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shobhalakshmi Sudarshan |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy
MSRIT post
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
pshobha76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobhalakshmi Sudarshan |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy
MSRIT Post
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
pshobha76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shobhalakshmi Sudarshan |
| Designation |
Professor |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy
MSRIT Post
Bangalore
Hebbal
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
pshobha76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah Hospitals, Ramaiah College of Physiotherapy
MSRIT Post
Bangalore - 560054, karnataka , India |
|
|
Primary Sponsor
|
| Name |
Ramaiah Hospitals Ramaiah College of Physiotherapy |
| Address |
MSRIT post
Bangalore- 560054
Karnataka
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shobhalakshmi Sudarshan |
Ramaiah Hospitals |
Center for Rehabiltation,Ramaiah Memorial hospital,
Room No 908 Ramaiah Medical Teaching Hospital
MSRIT post
Bangalore -560054
Bangalore
KARNATAKA |
09008025432
pshobha76@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ramaiah Medical college |
Approved |
| Ramaiah Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not Applicable |
| Intervention |
Pain science education |
"Pain science education" ,"pain education", "Pain Neuroscience education", is a cognitive behavioural intervention that explains pain as a neural output emerging from complex biological, psychological, and social interactions. It aims to facilitate patients’ understanding of pain mechanisms and promote the reconceptualization of maladaptive pain beliefs and alter maladaptive pain cognition
The duration of the intervention would be for approximately 3 - 4 sessions across 2 weeks . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-specific neck pain with no neurological problems
2. Age 18 years – 55 years
3. Neck pain in the cervical region, possibly with referred or radiating pain in the occiput, nuchal muscles, shoulders and upper limbs without proven structural disorders in the cervical spine, nerve roots or spinal cord .
4. Pain more than 3 months
5. Indian
6. Speak and read English/ kannada fluently.
7. Educational qualification – more than 10th Std.
|
|
| ExclusionCriteria |
| Details |
1. Signs and symptoms of neurological disorders
2. Recent history of fever or chills
3. Headache as a consequence of specific headache diagnosis (migraine, cervical headache)
4. History of specific signs of malignancy, infection
5. History of trauma with or without proven structural disorders in the region of the neck, shoulder and head
6. Signs and symptoms of cerebrovascular insufficiency
7. Severe chronic disease of the locomotor system
8. Osteoporosis
9. history of diagnosed severe mental health conditions( schizophrenia, severe depression , bipolar disorder ), that would limit conducting the trial procedures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Feasibility outcomes
Recruitment rate
Adherence to intervention Participant Satisfaction
Perceived Relevance
Acceptability / credibility of interventions |
Recruitment rate assessed at screening phase
Adherence to intervention at each session of week 1 & 2
Participant Satisfaction , Perceived Relevance and Accepatbility or credibility of interventions assessed post intervention week 2
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Clinical outcomes include
cervical range of motion
Pain using Numerical pain rating scale
Kinesiophobia using Tampa scale of kinesiophobia
Pain catastrophizing using pain catastrophizing scale
Neck disability using Neck disability index |
clinical outcomes shall be assessed at baseline & at 2 weeks
|
Intervention Fidelity outcomes include
Adherence to intervention content
Dosage of intervention
Delivery of intervention |
Fidelity outcomes shall be assessed at each session of week 1 & 2 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Recruitment not initiated as yet to provide any data .Chronic neck pain is a highly prevalent musculoskeletal disorder that contributes significantly to disability and reduced quality of life globally. Pain Science Education (PSE), which aims to reconceptualize pain from a biomedical to a biopsychosocial perspective, has shown promising results in reducing pain and disability in chronic musculoskeletal conditions. However, standard PSE programs are often developed in Western contexts and may not fully align with the cultural narratives, health beliefs, and language diversity prevalent in Indian populations. The current study aims to develop and assess the feasibility of a culturally adapted pain science education in individuals with chronic non specific neck pain. Following screening of subjects the study involves exploring the cultural beliefs, attitudes and perceptions related to chronic neck pain among Indian patients and healthcare providers. Based on the beliefs, perceptions and attitudes a pain science education content focusing on some of the key concepts of pain shall be developed .The developed content shall then be validated by a panel of pain experts. The developed and validated content shall be administered along with conventional Physiotherapy on Indian subjects with chronic non specific neck pain and assessed for pilot feasibility. Qualitative feedback will be subjected to thematic analysis to identify common suggestions,common patterns and barriers. For validation of the developed content quantitative ratings will be summarized using measures of central tendency (mean, median, IQR). Quantitative component of pain behaviour will be analysed through paired t test / Wilcoxon sign ranked test to determine pre test post -test difference. |