| CTRI Number |
CTRI/2025/12/098887 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on How Expectations Shape Symptoms and Recovery in Spine Patients |
|
Scientific Title of Study
|
EXPECTORA: A Prospective Observational Study of Expectation-Driven Phenomena in Patients with Spine Disorders |
| Trial Acronym |
EXPECTORA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad
GUJARAT
380006
India |
| Phone |
09825019913 |
| Fax |
|
| Email |
brd_172@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
2nd Floor - Reasearch Department , Stavya Spine Hospital and Research Institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bharat R Dave |
Stavya Spine Hospital & Research Institute |
2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Ahmadabad
GUJARAT |
09825019913
brd_172@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Cervical / Dorsal / Lumbar spine disoreder.
Able to complete the questionnaire.
|
|
| ExclusionCriteria |
| Details |
Urgent surgical emergencies.
Severe cognitive / psychiatric issues.
Spine surgery less than 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS,NDI / ODI , PHQ -9 & GAD - 7 |
NIL. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
23/12/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patient expectations strongly influence outcomes in
spine care. Whether expectations relate to pain relief, recovery time, surgical
success, or return to activity, these beliefs often shape reported
satisfaction, perceived improvement, and treatment decisions.
Despite their major role, expectation-driven syndromes remain poorly classified
in clinical science.
EXPECTORA is introduced as a new conceptual term that
represents exaggerated, unrealistic, or poorly aligned expectations that
influence perception, experience, and outcomes of treatment.
This phenomenon can cause dissatisfaction, misinterpretation of recovery,
treatment refusal, or contradictory preferences (e.g., demanding surgery vs
avoiding surgery).
Understanding Expectora offers an opportunity to
incorporate psychological and perceptual factors into modern spine care. |