| CTRI Number |
CTRI/2024/06/069343 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding patients concern and coping mechanism post degenerative lumbar spine surgery |
|
Scientific Title of Study
|
Getting back to living :A qualitative study on patients concern and coping mechanism following degenerative lumbar spine surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yukta Bafna |
| Designation |
Post graduate student |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD NO.05 Neurophysiotherapy Department Shri Dharmasthala
Manjunatheshwara College Of Medical Science and Hospital,
Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA
580009
India
Dharwad
KARNATAKA
580009
India |
| Phone |
7019063418 |
| Fax |
|
| Email |
yuktabafna252@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yukta Bafna |
| Designation |
Post graduate student |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD NO.05 Neurophysiotherapy Department Shri Dharmasthala
Manjunatheshwara College Of Medical Science and Hospital,
Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA
580009
India
Dharwad
KARNATAKA
580009
India |
| Phone |
7019063418 |
| Fax |
|
| Email |
yuktabafna252@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Dudhani |
| Designation |
Professor and PG guide |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD NO.05 Neurophysiotherapy Department Shri Dharmasthala
Manjunatheshwara College Of Medical Science and Hospital,
Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA
580009
India
Dharwad
KARNATAKA
580009
India |
| Phone |
9880950990 |
| Fax |
|
| Email |
sharmila.dudhani@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Physiotherapy Sattur,Dharwad,Karnataka, India 580009 |
|
|
Primary Sponsor
|
| Name |
Yukta Bafna |
| Address |
SDM College of Physiotherapy.
Manjushree Nagar Sattur
Dharwad Karnataka India 580009 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Sharmila Dudhani |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
OPD NO 5 NEUROPHYSIOTHERAPY OPD MANJYSHREE BUILDING DHARWAD KARNATAKA
Dharwad
KARNATAKA |
7019063418
yuktabafna252@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G541||Lumbosacral plexus disorders, (2) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Any gender
2. Subjects operated for degenerative lumbar spine
surgery with age 30 – 65 years.
3. Post- surgical duration: ≥1year post degenerative
lumbar spine surgery.
4. Subjects who can understand English, Hindi,
Kannada |
|
| ExclusionCriteria |
| Details |
. Subjects who do not have any problem : ≥1year post
degenerative lumbar spine surgery
2. .Subjects with any musculoskeletal or neurological
comorbidities(like Arthritis, Stroke, Parkinson’s
disease, Multiple Sclerosis, Gullian Barre Syndrome,
etc
3. Subjects with a history of any psychiatric illness
4. Subjects with cognitive impairment who cannot
understand or communicate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Semi Structured Interview |
1 time assessment post 1 year of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
18/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Patients post degenerative lumbar spine surgery are affected not only with leg pain or back pain, but also with other physical symptoms like numbness, coldness, or paraesthesia in the lower limbs and dull ache in the lower back In addition to these physical symptoms there are other aspects that can influence the recovery of the patients post degenerative lumbar spine surgery like psychosocial variables- presurgical somatization, depression, anxiety, and poor coping Despite the fact that patients undergoing degenerative lumbar spine surgery have relief in terms of pain and disability, they are still dealing with concerns about physical, psychological and social wellbeing and some patients may also have issues related to return to work. It is important to know the concerns of such patients and how they are coping with same. Such an insight may provide valuable data for future research. Most of the studies in post degenerative lumbar spine surgery are quantitative in nature, the current study will help find patients perspective about their concerns and coping mechanisms |