| CTRI Number |
CTRI/2024/04/065429 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
An easy way to understand training and exercises before the operation for low back pain to reduce pain and fear to move after the operation |
|
Scientific Title of Study
|
Efficacy Of Culturally Sensitive Prehabilitation In Improving Post Operative Pain And Fear Of Movement In Individuals With Lumbar Degenerative Disc Disease – An 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 |
Harsha Wadhwani |
| Designation |
clinical therapist |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Mahatma Gandhi Mission School of Physiotherapy
N-6 CIDCO, Chhatrapati Sambhajinagar-431003, A Constituent unit of MGMIHS, Navi Mumbai
Department of Musculoskeletal Physiotherapy, Mahatma Gandhi Mission School of Physiotherapy
N-6 CIDCO, Chhatrapati Sambhajinagar-431003, A Constituent unit of MGMIHS, Navi Mumbai
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9404880712 |
| Fax |
|
| Email |
harsha14wadhwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaibhavi Walimbe |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy
N-6 CIDCO, Aurangabad-431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
|
| Fax |
|
| Email |
vaibhavi.walimbe@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Harsha Wadhwani |
| Designation |
clinical therapist |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Mahatma Gandhi Mission School of Physiotherapy
N-6 CIDCO, Chhatrapati Sambhajinagar-431003, A Constituent unit of MGMIHS, Navi Mumbai
Department of Musculoskeletal Physiotherapy, Mahatma Gandhi Mission School of Physiotherapy
N-6 CIDCO, Chhatrapati Sambhajinagar-431003, A Constituent unit of MGMIHS, Navi Mumbai
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9404880712 |
| Fax |
|
| Email |
harsha14wadhwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital Chh Sambhajinagar |
|
|
Primary Sponsor
|
| Name |
Harsha Wadhwani |
| Address |
MGM School of Physiotherapy
N-6 CIDCO, Aurangabad-431003
|
| Type of Sponsor |
Other [personal] |
|
|
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 |
| Harsha Wadhwani |
MGM Medical College and Hospital |
Department of Musculoskeletal Physiotherapy, Mahatma Gandhi Mission School of Physiotherapy
N-6 CIDCO, Chhatrapati Sambhajinagar-431003, A Constituent unit of MGMIHS, Navi Mumbai
Aurangabad
MAHARASHTRA |
9404880712
harsha14wadhwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
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 |
| Intervention |
Culturally sensitive Pre-habilitation |
10 sessions of Pre-habilitation (BD) along with 5 sessions of culturally sensitive patient education |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients undergoing surgery for degenerative disc disease
2)NPRS criteria- 5 or more
3)Kinesiophobia (TAMPA scale)- score of 37 or more
4)Both male and female patients |
|
| ExclusionCriteria |
| Details |
1) Patient with non surgical condition.
2)Patients with previous surgical history.
3)Patients with other musculoskeletal conditions.
4)Patients with prior back surgery, and spinal infections.
5)Other metabolic diseases, pregnancy and malignancy.
6)Abdominal pathologies and renal calculi. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain (NPRS) |
one week (7 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fear of movement (TAMPA scale of kinesiophobia) |
pre-outcome measure day 1 and post outcome measure day 7 |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
15/04/2024 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - scientific journals
- For how long will this data be available start date provided 16-09-2024 and end date provided 16-09-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Recriutment has not yet been started. Recruitment will start after the study is registered at CTRI. |