| CTRI Number |
CTRI/2026/03/105248 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study on the effect of pain education on recovery in patients undergoing spinal surgery |
|
Scientific Title of Study
|
Effect of preoperative Pain Neuroscience Education (PNE) on postoperative pain, pain cognition and readiness towards physiotherapy in patients undergoing spinal laminectomy: A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abigail Halle Vaz |
| Designation |
Student, Master of Physiotherapy |
| Affiliation |
Goa Medical College, Bambolim |
| Address |
Master of Physiotherapy Course, Allied Health Sciences Courses, Department of Orthopedics, Goa Medical College and Hospital, Bambolim
North Goa
GOA
403202
India |
| Phone |
9373095412 |
| Fax |
|
| Email |
abigailvaz2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jorida Fernandes PhD MPT |
| Designation |
Associate Professor in Physiotherapy |
| Affiliation |
Goa Medical College, Bambolim |
| Address |
Master of Physiotherapy Course, Allied Health Sciences Courses, Department of Orthopedics, Goa Medical College and Hospital, Bambolim
North Goa
GOA
403202
India |
| Phone |
9060778888 |
| Fax |
|
| Email |
jorida.fernandes@goa.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jorida Fernandes PhD MPT |
| Designation |
Associate Professor in Physiotherapy |
| Affiliation |
Goa Medical College, Bambolim |
| Address |
Master of Physiotherapy Course, Allied Health Sciences Courses, Department of Orthopedics, Goa Medical College and Hospital, Bambolim
GOA
403202
India |
| Phone |
9060778888 |
| Fax |
|
| Email |
jorida.fernandes@goa.gov.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Goa Medical College |
| Address |
Goa Medical College and Hospital, Bambolim, Tiswadi - North Goa 403202 |
| 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 |
| Abigail Vaz |
Goa Medical College |
Department of Neurosurgery, Bambolim, Tiswadi, North Goa, 403202
North Goa
GOA |
9373095412
abigailvaz2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M480||Spinal stenosis, (2) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biomedical Education - one preoperative session |
one preoperative Biomedical education regarding the surgical procedure, its benefits and risks |
| Intervention |
Preoperative Pain Neuroscience Education - one 45 minute session preoperatively |
one 45 minutes, one to one PNE education session preoperatively along with a booklet with PNE related information |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants undergoing elective spinal laminectomy for the first time
Able to read and speak English or Konkani
Mini Mental Status Examination (MMSE) score more than or equal to 24
Willingness to participate |
|
| ExclusionCriteria |
| Details |
Participants who have undergone previous spine surgery
Participants undergoing spinal laminectomy for neoplasms or spinal space occupying lesion
History of psychiatric disorders (e.g., depression)
Presence of systemic or inflammatory rheumatic diseases (e.g.,
spondyloarthritis, rheumatoid arthritis) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative pain intensity, pain catastrophization, kinesiophobia, fear avoidance behaviour, readiness towards physiotherapy in patients |
Baseline (preoperatively), post operatively D2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
16/03/2026 |
| 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
|
Spinal laminectomy is a frequent surgical intervention following which, patients often experience intense pain and maladaptive pain cognitions which can significantly delay their postoperative rehabilitation and recovery. This study aims to investigate the efficacy of providing preoperative Pain Neuroscience Education to these patients. The primary goal is to evaluate how this targeted educational intervention affects the patients postoperative pain intensity, pain cognitions and their readiness to engage in physiotherapy.
Participants scheduled for a spinal laminectomy will be recruited and allocated to either an experimental group or a control group. The experimental group will receive a specific educational session focused on the neurophysiological processes of pain prior to their surgery. This intervention aims to alter maladaptive pain beliefs and reduce fear avoidance behaviors. The control group will receive standard preoperative education and routine instructions.
Outcomes will be measured using standardized tools including pain catastrophisation questionnaire, Tampa scale of kinesiophobia, fear avoidance beliefs questionnaire and the revised neurophysiology of pain questionnaire to assess cognitive shifts alongside standard pain scales. The study hypothesizes that patients receiving the preoperative Pain Neuroscience Education will demonstrate decreased pain levels, improved pain cognition and a higher readiness for early mobilization compared to the control group. Ultimately this study seeks to determine if integrating this educational component can optimize surgical outcomes, pain cognitions and enhance adherence to physical therapy. |