| CTRI Number |
CTRI/2024/12/077598 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of rehabilitation on mind, body and social life in patients after computer-assisted spine surgery |
|
Scientific Title of Study
|
Effect of Biopsychosocial Model of rehabilitation on Functional disability and Pain in patients after Robotic Assisted Lumbar Fusion Surgery: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jomi John |
| Designation |
PhD Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement, Department of Physiotherapy, Manipal Hospital,
No 98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9645445865 |
| Fax |
|
| Email |
jomi.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Karvannan |
| Designation |
Head and Associate Professor |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCAYION |
| Address |
Upper basement, Department of Physiotherapy, Manipal Hospital #98, Old Airport Road, Bangalore KARNATAKA 560017 India
MCHP
Bangalore
KARNATAKA
560017
India |
| Phone |
09986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Karvannan |
| Designation |
Head and Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement, Department of Physiotherapy, Manipal Hospital,
No.98, Rustam Bagh, Old Airport Road, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
09986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of
Higher Education, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore
KARNATAKA 560017 India Bangalore KARNATAKA 560017 India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL, Old
Airport Road, Bangalore Karnataka 560017, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jomi John |
Manipal Hospitals |
Ground floor, Department of Spine Surgery, Manipal Comprehensive Spine Care Center, Manipal Institute of Robotic Spine Surgery. Manipal Hospitals Bangalore, #98, HAL Old Airport Road, Bangalore, KARNATAKA 560017, India
Bangalore
KARNATAKA |
09645445865
jomi.mhsblr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Manipal Hospitals Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biopsychosocial Model of rehabilitation |
The Biopsychosocial Model of rehabilitation will be given for three months and it focuses on treating patients biological, psychological and social factors influencing patients illness. This will include exercises, progressive muscle relaxation, pain coping skills, pleasant activity, and the education of family members. Supervised treatment will be given in IPD (2 sessions), Supervised treatment will be given in OPD (6 sessions) and Unsupervised treatment from 4 weeks to three months. Duration of the supervised treatment will be 40 to 50 minutes. |
| Comparator Agent |
Conventional rehabilitation |
The conventional interventions will be given for three months and the intervention focuses on treating the Physiological and anatomical causes of a patients illness. This will include patient education, breathing exercises, walking, range of motion exercise, strengthening exercises and stretching exercises. Supervised treatment will be given in IPD (2 sessions), Supervised treatment will be given in OPD (6 sessions) and Unsupervised treatment from 4 weeks to three months.Duration of the supervised treatment will be 40 to 50 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing index single-level or two-level fusion between the ages of 18 and 65 from L1 to S1.
Patient selected for lumbar fusion with decompression
A primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease.
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed with inflammatory conditions like Rheumatoid arthritis and Ankylosing spondylitis
Severe cardiorespiratory or patients with neurological deficits (ASIA C and above)
Severe psychiatric/psychological disorder
Alcohol abuse
Immediate complications after surgery (infection) Degenerative or idiopathic scoliosis
History of malignancy in spine
Poor post-operative General health condition
Spinal fracture
Worsening of existing or the appearance of new symptoms.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index and Visual Analogue Scale |
At Baseline assessment (Before the surgery), two weeks after surgery, four weeks after surgery and twelve weeks after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up & Go Test |
At Baseline assessment (Before the surgery), two weeks after surgery, four weeks after surgery & twelve weeks after surgery. |
| Pain catastrophizing Scale |
At Baseline assessment (Before the surgery), two weeks after surgery, four weeks after surgery & twelve weeks after surgery. |
| SF 36 questionnaire |
At Baseline Assessment (Before surgery) & twelve weeks after surgery |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
15/12/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The biopsychosocial model demonstrates a
positive impact on musculoskeletal conditions. Research investigating its
application in post-operative management has documented positive effects on
catastrophizing pain management and functional outcomes.However,
a knowledge gap remains in assessing the rehabilitation impact following
robotic-assisted lumbar fusion. |