| CTRI Number |
CTRI/2025/11/097437 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| 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
|
Pre surgery education to reduce fear of movement and pain after spine surgery |
|
Scientific Title of Study
|
Effect of Preoperative patient education on kinesiophobia and pain in individuals undergoing spinal surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwika Barathi K |
| Designation |
Post Graduate Student |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
Room number 303,3rd floor, department of physiotherapy ,M S Ramaiah medical college and hospital, M S Ramaiah Nagar, MSRIT post, Bangalore, Karnataka,560054,India
Bangalore
KARNATAKA
560054
India |
| Phone |
9600899146 |
| Fax |
|
| Email |
ashwikabk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobhalakshmi S |
| Designation |
Professor |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
Room number 303,3rd floor, department of physiotherapy, M S Ramaiah medical college and hospital, M S Ramaiah Nagar, MSRIT post, Bangalore, Karnataka,560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
shobhaholla.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shobhalakshmi S |
| Designation |
Professor |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
Room number 303,3rd floor, department of physiotherapy, M S Ramaiah medical college and hospital, M S Ramaiah Nagar, MSRIT post, Bangalore, Karnataka,560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9008025432 |
| Fax |
|
| Email |
shobhaholla.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah University of Applied sciences, M S Ramaiah Nagar, MSRIT post, Bangalore , 560054 |
|
|
Primary Sponsor
|
| Name |
Ashwika Barathi K |
| Address |
M S Ramaiah college of physiotherapy, M S Ramaiah Nagar, MSRIT post, Bangalore-560054 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashwika Barathi K |
M S Ramaiah Medical College and hospitals,Bangalore urban community |
Orthopaedic wards, 1st floor,M S Ramaiah medical college and hospitals , M S Ramaiah Nagar,MSRIT post, Bangalore, Karnataka, 560054
Bangalore
KARNATAKA |
9600899146
ashwikabk@gmail.com |
| Ashwika Barathi K |
M S Ramaiah Memorial Hospital |
Orthopaedic wards, 1st floor to 8th floor , M S Ramaiah memorial hospital , M S Ramaiah Nagar,MSRIT post, Bangalore, Karnataka, 560054
Bangalore
KARNATAKA |
9600899146
ashwikabk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical college and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Preoperative patient education |
Participants in the intervention group will receive a structured preoperative physiotherapy-based patient education session designed to improve understanding of the surgical procedure, address fear of movement (kinesiophobia), and explain postoperative mobility and exercise expectations. The session will be delivered once prior to surgery through verbal explanation and an educational booklet by a physiotherapist.
Participants in the control group will receive routine preoperative care without any structured education session.
Both groups will be assessed for pain (Numeric Pain Rating Scale) and kinesiophobia (Tampa Scale for Kinesiophobia) postoperatively to evaluate the effect of preoperative education. Frequency of the intervention will be one time session with a duration of 20-30 minutes |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Scheduled for Posterior instrumented stabilization and decompression surgery
2. Age – 25-60 years
3. Individuals who are able to understand and follow instructions
4. Patients who are able to understand English, Kannada or Tamil
|
|
| ExclusionCriteria |
| Details |
1.Surgery due to malignancy and infection
2.Neurological deficits(cauda equina syndrome, severe myelopathy) Individuals with
cognitive impairments affecting understanding
3. Patients unable to comprehend the education content and language barriers
4.Patients with other concurrent musculoskeletal deficits |
|
|
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 |
Change in kinesiophobia levels measured using the Tampa Scale for Kinesiophobia (TSK) before and after surgery between the intervention and control groups.
|
Preoperatively at baseline (1 day before surgery) and postoperatively at hospital discharge ( postoperative day 3- day 5)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) before & after surgery between the intervention & control groups.
|
Preoperatively at baseline(1 day before surgery) & postoperatively at hospital discharge(postoperative day 3- day 5) |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
27/11/2025 |
| 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 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
|
The study aims to evaluate the effect of preoperative patient education on kinesiophobia and pain in individuals undergoing spinal surgeries. Participants will be randomly allocated into two parallel groups: • Intervention group: Will receive a structured preoperative education session by a physiotherapist, including information about surgery, postoperative mobility, exercises, and fear of movement (kinesiophobia) management. • Control group: Will receive routine preoperative care without any structured education session.
Both groups will be assessed for pain (Numeric Pain Rating Scale) and kinesiophobia (Tampa Scale for Kinesiophobia) before surgery and postoperatively.
The study follows a randomized parallel group design to determine whether preoperative education reduces postoperative pain and kinesiophobia in spinal surgery patients. |