| CTRI Number |
CTRI/2024/12/077957 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [PhD Study] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of lumbopelvic-hip stability exercises on pain, physical performance and self-efficacy in patients with chronic nonspecific low back pain |
|
Scientific Title of Study
|
Effect of lumbopelvic-hip stability exercises on pain, physical performance and self-efficacy in patients with chronic nonspecific low back pain- 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 |
Bhavana Mhatre |
| Designation |
Professor |
| Affiliation |
Physiotherapy School and centre, Seth G.S. Medical college and KEM Hospital |
| Address |
Physiotherapy School and centre, Seth G.S. Medical college and KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
28bhavanamhatre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Mhatre |
| Designation |
Professor |
| Affiliation |
Physiotherapy School and centre, Seth G.S. Medical college and KEM Hospital |
| Address |
Physiotherapy School and Centre, Seth G.S. Medical College and Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
28bhavanamhatre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pravin Gawali |
| Designation |
PhD Scholar |
| Affiliation |
Physiotherapy School and centre, Seth G.S. Medical college and KEM Hospital |
| Address |
Physiotherapy School and Centre, Seth G.S. Medical College, KEM Hopsital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9503358020 |
| Fax |
|
| Email |
drpravingawali3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy School and centre, seth G.S. Medical College, KEM Hospital, Mumbai, India. PIN Code 400012 |
|
|
Primary Sponsor
|
| Name |
Pravin Gawali |
| Address |
Physiotherapy School and Centre Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India. PIN Code 400012 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pravin Gawali |
Physiotherapy School and Centre, Government Medical College, Nagpur |
Main OPD Building, Physiotherapy Department, Physiotherapy OPD Unit, 93 No., First Floor.
Nagpur
MAHARASHTRA |
9503358020
drpravingawali3@gmail.com |
| Dr Pravin Gawali |
Physiotherapy School and Centre, Seth G.S. Medical College and KEM Hospital, Mumbai |
Physiotherapy Departemnt, Physiotherapy OPD, Ground and 1st FLOOR.
Mumbai
MAHARASHTRA |
9503358020
drpravingawali3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Nagpur |
Approved |
| Institutional Ethics Committee IEC III, Relating to biomedical and Health Research, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M549||Dorsalgia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lumbopelvic Hip Stability Exercises |
Lumbopelvic Stability Exercises will be given with addition to Hip Stability Exercises, twice a week for six weeks, total 12 sessions. |
| Comparator Agent |
Lumbopelvic stability exercises |
lumbo-pelvic stability exercises, twice a week for six weeks, total 12 sessions. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
A reported minimum score of 5 and more than 5 out of 10 on NPRS.
Location of pain: Below the costal margin and above the gluteal folds
With or without somatic referred (Dull aching) pain in the leg.
NSLBP referred by an orthopedic surgeon for physiotherapy. |
|
| ExclusionCriteria |
| Details |
Radicular Pain -sharp shooting in dermatomal pattern.
History of spinal surgery,
History of ankylosing spondylitis or rheumatoid arthritis,
History of spondylolisthesis or spondylolysis,
History of spinal or pelvic fracture,
History of spinal inflammation or tumor,
History of osteoporosis,
Continuous use of pain medications
History of stroke,
History of respiratory disease or heart disease, or
Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain-NPRS
Physical Performance-
One Minute sit to stand
Timed up and go test
Self Efficacy-
Pain Self Efficacy Questionnaire |
at baseline and after six weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
16/12/2024 |
| 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 Applicable |
| 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 - NO
|
|
Brief Summary
|
A randomized controlled trial will be conducted as per the guidelines/statement given by CONSORT 2010 (Consolidated Standards of Reporting Trials). The research will be carried out as per the approval of the head of the institutes and Institutional Ethical Committee. The study protocol will be conducted according to the declaration of Helsinki. Evaluation of the participant will be done at the baseline on first day, using NPRS for low back pain intensity, Physical Performance by One Minute Sit to Stand Test and Timed up and go test, Self-Efficacy by Pain Self Efficacy Questionnaire (PSEQ) and assessment will be documented accordingly. Re-assessment using same outcome measures will be done after completion of treatment protocol of 6-weeks for both the groups. The study will be blinded by assigning the experienced Physiotherapy colleague with experience of more than 15 years for the assessment of the subject at the time of recruitment and on completion of the treatment protocol after six weeks. This study will have two experimental group, Random allocation of subjects who meet inclusion criteria and give consent for the study will be allocated to either of the two groups. Group A and Group B by table of random sequence generation generated by computer online. Group A will receive Lumbopelvic stability exercises and Group B will receive lumbo-pelvic exercises with the addition of hip joint stability exercises. All the exercises will focus on retraining motor control a core muscles with addition of hip joint local and global stabilizers. Assessment of the faulty posture and faulty movement patterns, and importance of exercise program will be explained on first session. Two sessions per week will be given followed by home exercise program for six weeks. The treatment protocol will be participant specific and progression will be made according to the participant’s performance. Any drop-outs or participants lost to follow-up will be mentioned with appropriate reasoning. At the end of the study the data will be collected, coded and tabulated using descriptive and inferential statistics. All analysis will be done using SPSS for Windows.
|