| CTRI Number |
CTRI/2021/09/036408 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
03/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of early ambulation on pain, functional capacity and quality of life of patients after spine surgeries |
|
Scientific Title of Study
|
The effect of early ambulation on pain, functional outcome and quality of life in postoperative subjects with lumbar decompression and discectomy surgeries: A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalvi Boralkar |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy Department, 12 Thube Park, Shivajinagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
08999148605 |
| Fax |
|
| Email |
shalvi.boralkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sona Kolke |
| Designation |
Associate professor, Department of Musculoskeletal Physiotherapy |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy Department, 12 Thube Park, Shivajinagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalvi Boralkar |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
1st floor, Sancheti Institute College of Physiotherapy, Musculoskeletal Physiotherapy Department, 12 Thube Park, Shivajinagar Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
08999148605 |
| Fax |
|
| Email |
shalvi.boralkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti institute college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti institute college of physiotherapy |
| Address |
Sancheti institute college of physiotherapy 12 Thube Park Shivajinagar Pune 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Shalvi Boralkar |
Sancheti Hospital for Orthopedics and Rehabilitation |
16,floor-1 Department of musculoskeletal Physiotherapy, ward A, ward B, ward E and ward I, room number 201,325 Shivajinagar, Pune
Pune
MAHARASHTRA |
08999148605
shalvi.boralkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambulation |
Ambulation after 24 hors of surgery |
| Intervention |
Early ambulation after surgery |
Ambulation within 4 to 6 hour of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who will have undergone one and two levels Lumbar Decompression and/or Discectomy surgeries and approved by treating surgeon.
|
|
| ExclusionCriteria |
| Details |
1)Subjects having Cauda equina syndrome
2)Surgeries for trauma, instability or deformity correction, revision spinal surgeries, infective spondylodiscitis
3) Subjects who are unable to tolerate standing position or walking on the day of operation
4) Osteoporosis
5) Comorbiditis of cardiac or respiratory nature which compromises their walking capacity
6) Intraoperative and postoperative complications. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Visual Analog Scale
2) Timed Up and Go test
3) Modified Oswestry Low Back Pain Disability questionnaire
4) SF-12 questionnaire |
On the Day of discharge and one month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2021 |
| Date of Study Completion (India) |
08/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised control trial that will analyse the effect of early ambulation on subjects following lumbar decompression and/ or discectomy surgeries on Pain, Functional Outcome and Quality of life. Subjects will be divided into two groups; the experimental group will be ambulated within 4 to 6 hours of surgery and the control group will be ambulated as per the protocol (after 24 hours of surgery). Pain (assessed by Visual Analogue scale), Timed Up and Go test and Modified Oswestry Low Back Pain Disability questionnaire will be analysed on the day of discharge and one month after surgery. The quality of life (SF-12 questionnaire) will be analysed one month after surgery.
|