| CTRI Number |
CTRI/2021/09/036583 [Registered on: 16/09/2021] Trial Registered Prospectively |
| Last Modified On: |
10/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Recovery of activities following age related back surgery. |
|
Scientific Title of Study
|
“RECOVERY OF ACTIVITIES AND FACTORS INFLUENCING THEM IN POST DEGENERATIVE LUMBAR SPINE SURGERY†- A QUALITATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POOJA SHRINIWAS BALYAPELLI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO 5
NEUROPHYSIOTHERAPY DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD OPD NO 5
NEUROPHYSIOTHERAPY DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD Dharwad KARNATAKA 580009 India |
| Phone |
8850182530 |
| Fax |
|
| Email |
poojabalyapelli96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
POOJA SHRINIWAS BALYAPELLI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO 5
NEUROPHYSIOTHERAPY DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD OPD NO 5
NEUROPHYSIOTHERAPY DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD Dharwad KARNATAKA 580009 India |
| Phone |
8850182530 |
| Fax |
|
| Email |
poojabalyapelli96@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SHARMILA DUDHANI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD NO 5
NEUROPHYSIOTHERAPY DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD OPD NO 5
NEUROPHYSIOTHERAPY DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD Dharwad KARNATAKA 580009 India |
| Phone |
9880950990 |
| Fax |
|
| Email |
sharmiladudhani268@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
POOJA SHRINIWAS BALYAPELLI |
| Address |
SDM COLLEGE OF PHYSIOTHERAPY
MANJUSHREE NAGAR SATTUR
DHARWAD KARNATAKA |
| 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 DEPARTMENT
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
MANJUSHREENAGAR SATTUR DHARWAD Dharwad KARNATAKA |
9880950990
sharmiladudhani268@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Permission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G319||Degenerative disease of nervous system, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Both males and females
2. Subjects operated for degenerative lumbar spine surgery with age ≥30 years.
3. Post- surgical duration: ≥1- 2 year post degenerative lumbar spine surgery. 25
4. Subjects who can understand English, Hindi, Kannada. |
|
| ExclusionCriteria |
| Details |
1. Subjects with any musculoskeletal or neurological comorbidities
(like Stroke, Parkinson’s disease, Multiple Sclerosis, Gullian Barre Syndrome, etc.)
2. Subjects with cognitive impairment who cannot understand or communicate.
3. Subjects not willing to participate in this study. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| structured interview |
one time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| structured interview method |
one time assessment |
|
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Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
21/09/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The recovery of the patient’s functional impairment who have underwent lumbar spine surgery is also multifactorial, the causes for restriction of movements can be very distant. For example, a study has shown that degenerative spine disease patients experiencing more social support and less life stress tend to report greater satisfaction in medical outcome and overall quality of life following spinal decompression. 21 A study on critical analysis of the exercise prescription and return to activity advise following lumbar spine surgery highlights a clear variation in the recommendations of the exercise prescription, dosage and returning to normal activities following lumbar spine surgery. The study emphasizes that the patient information leaflet lacks a relationship to functional activity and their effectiveness is questioned. Furthermore because of the multidimensional nature of the treatment of low back / radicular leg pain there is a need to emphasize on psychological and social support. The study concludes a need to focus on providing a consistent and patient centered approach to recovery. 22 Most outcome measures used, following lumbar spine surgeries have quantified answers, but the experiences and the views of the patients are rarely explored. Therefore, it is important to understand by an in-depth interview of which movements or activities are restricted and what could be the probable factors influencing them. The range of activities that may be restricted in the Indian scenario is quite different considering our culture. Understanding these activities and factors affecting them could play a very significant role to have a patient centered approach in patients who have underwent degenerative lumbar spine surgery. Hence there is a need to see which activities are restricted and what are the factors influencing them in degenerative lumbar spine surgery patients. The objective of the study is to explore restricted activities post Degenerative Lumbar Spine Surgery and the factors influencing them. |