FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G319||Degenerative disease of nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 
 
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 
 
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.
 
Close