| CTRI Number |
CTRI/2024/08/072756 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of core muscle strengthening exercises and scar tissue release in concomitant low back pain after lumbar fusion.A Clinical trial |
|
Scientific Title of Study
|
Effectiveness of core muscle strengthening exercises and scar tissue release in concomitant low back pain after lumbar spine fusion
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShraddha Prataprao Kothawale |
| Designation |
Assistant Professor,Musculoskeletal Physiotherapy Dept. |
| Affiliation |
Sir Dr.M.S.Gosavi College of Physiotherapy and HCM,Nashik |
| Address |
Uday Bunglow,shankar patil nagar near monalisa beauty parlour,untawadi,New nashik
Currently working in Gokhale Education society,near Krushi nagar jogging track,college road ,Nashik
Nashik
MAHARASHTRA
422009
India |
| Phone |
9970248704 |
| Fax |
|
| Email |
shrakothawale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rakesh Sinha |
| Designation |
Principal Dr.APJ Abdul Kalam college of physiotherapy,loni |
| Affiliation |
Pravara institute of medical sciences,loni |
| Address |
Pravara Institute of medical sciences .
Dr.APJ Abdul Kalam college of Physiotherapy ,Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
09799783783 |
| Fax |
|
| Email |
principal.cpt@pmtpims.org |
|
Details of Contact Person
Public Query
|
| Name |
DrShraddha Prataprao Kothawale |
| Designation |
Assistant Professor phd scholar student |
| Affiliation |
Pravara institute of medical sciences,loni |
| Address |
Uday Bunglow,shankar patil nagar near monalisa beauty parlour,untawadi,New nashik
Pravara Institute of medical sciences ,loni
Ahmadnagar
MAHARASHTRA
422009
India |
| Phone |
9970248704 |
| Fax |
|
| Email |
shrakothawale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Data gather from pravara Institute of medical sciences(Deemed universit,loni -413736 |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical college and hospitalloni |
| Address |
Pravara Institute of Medical college and hospital,Loni-413736 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Intervention study |
Hospitals where post operative lumbar fusion patients coming for follow up. |
| 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 |
| DrShraddha Prataprao Kothawaleprincipal Investigator |
Pravara Institute Of medical sciences |
Pravara Institute of medical sciences .
APJ Abdul Kalam college of Physiotherapy ,Loni
Ahmadnagar
MAHARASHTRA |
9970248704
2422-271426
shrakothawale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core muscle strengthening (group A)
Scar tissue release+Core muscle strengthening (Group B) post lumbar fusion patients |
Study starts after3 weeks post operatively lumbar fusion patients .9 weeks protocol given for 2 times in a week for 60 minutes. study will complete till 2 year |
| Comparator Agent |
Scar tissue release for lumbar fusion patients. |
Scar tissue release will give twice in a week .for 9 weeks after lumbar fusion surgery.will give release for 30 minutes.Will give scar tissue release around the suture site because after 3 week post op the fibrosis is going to form around the suture which gives pain and reduce lumbar range of motion. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants included will be:
Post operative lumbar fusion after 3 weeks of surgery
Age between 45 and 70 years both male and female patients.
The absence of non –communicable diseases i.e.cancer,heart disease,stroke
|
|
| ExclusionCriteria |
| Details |
Previous lumbar fusion surgery
Degenerative or Idiopathic Scoliosis
And Inflammatory disease like autoimmune diseases such as rheumatoid arthritis ,heart disease,COPD
and history of malignancy (Risk of cancer after lumbar fusion surgery with recombinant human bone morphogenic protein-2)
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 6 minute walk test,Lumbar Range of motion,Oswestry disability scale,Visual analogue scale |
6 minute walk test,Lumbar Range of motion,Oswestry disability scale,Visual analogue scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 6 minute walk test
2.Oswestry disability index
3.Visual analogue scale
4.Lumbar Range of motion
|
6 minute test is submaximal test for strength and endurance .visual analogue is pain scale. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="2"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response (Others) - age,gender,BMI ETC.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response (Others) - INFORM CONSENT FORM
- Who will be able to view these files?
Response (Others) - RESERCHER AND PRIMARY COINVESTIGATOR
- For what types of analyses will this data be available?
Response (Others) - TO ACHIEVE AIMS IN THE APPROVED PROPOSAL
- By what mechanism will data be made available?
Response (Others) - shrakothawale@gmail.com
- For how long will this data be available start date provided 11-07-2024 and end date provided 10-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Degenerative disc and facet joint disease of the lumbar spine is common in the ageing population and is one of the most frequent causes of disability.Lumbar spondylosis may result in mechanical back pain,radicular and claudication symptoms,reduced mobility and poor quality of life.Surgical interbody fusion of degerative levels is an effective treatment option to stabilize the painful motion segment ,and may provide indirect decompression of neural elements,restore lordosis and correct deformity.The surgical options for interbody fusion of lumbar spine include -posterior lumbar interbody fusion,transformaminal lumbar interbody fusion,minimally Invasive transforaminal interbody fusion,oblique lumbar interbody fusion,lateral lumbar interbody fusion.In gereral traditional posterior approaches are frequently used with acceptable fusion rates and low complication risk. Despite the significant rise in Lumbar spine fusion(LSF) surgery rates in the last few decades,some 15 to 40% of lumbar fusion patients cannot except significant improvement postoperatively according o functional ability. postoperative rehabilitation strategy is one of the main factors affecting the outcome. Need of study-Post surgical pain syndrome is becoming an increasing common challenge for clinicians who deals with spine disorders owing to the expanding indications for spine surgery and aging world population. A multidisplinary approach is most appropriate for patients who are unlikely to benefit from further formal surgical intervention.with the growth in popularity of scar tissue release over last two decades.It is time to critically examine many of the concept behind it. Therefore,the purpose of this study is to find out the effectiveness of core muscle strengthening exercises and scar tissue release in concomitant low back pain after lumbar fusion surgery. |