| CTRI Number |
CTRI/2024/10/075609 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| 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
|
To See the Effectivenes of Giving Posture Control Exercises and Abdominal and Back Muscle Strengthening Exercises On Endurance and Function in Young Adults uffering From Chronic non Specific Low Back Pain |
|
Scientific Title of Study
|
Effect Of Progressive Postural Control Exercise Versus Core Strengthening Exercise On Pain Core Muscle Endurance and Funtional Disability Amongst
Young Adults With Non Specific Chronic Low Back Pain a Comparative Study |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Mehta |
| Designation |
Pg Scholar |
| Affiliation |
Parul University |
| Address |
Opd No 201 2nd Floor, PSH, Parul University ,Limda, Taluka Waghodia , vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
6354128244 |
| Fax |
391760 |
| Email |
kissumehta21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhavi Sontakkey |
| Designation |
Assistant Professor |
| Affiliation |
Parul University |
| Address |
Opd No 201 2nd Floor, PSH, Parul University, Limda, Taluka ,Waghodia, Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9106987631 |
| Fax |
391760 |
| Email |
madhavi.sontakkey28201@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Madhavi Sontakkey |
| Designation |
Assistant Professor |
| Affiliation |
Parul University |
| Address |
Opd No 201 2nd Floor, PSH, Parul University, Limda, Taluka ,Waghodia, Vadodra
Vadodara
GUJARAT
391760
India |
| Phone |
9106987631 |
| Fax |
391760 |
| Email |
madhavi.sontakkey28201@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Opd No 201 2nd Floor, PSH, Parul University, Limda, Taluka ,Waghodia, Vadodra, Gujarat ,India 391760 |
|
|
Primary Sponsor
|
| Name |
NILL |
| Address |
NILL |
| Type of Sponsor |
Other [NILL] |
|
|
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 |
| krishna mehta |
parul university |
parul university limda waghodia gujarat
Vadodara
GUJARAT |
6354128244
391760
kissumehta21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee For Human Research(PU-IECHR) |
Approved |
| PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH(PU-IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core strengthening exercise |
All the participants with chronic non specific low back pain will be screened for inclusion criteria.
Ones falling into the inclusion criteria will be recruited and asked to sign the consent form. subjects will have complete freedom to refuse from participating in the study.
Once the consent form is signed the subjects will then be divided into two groups, group a (progressive postural control exercise) & group b (core strengthening).
All the participants will be assessed and for outcome measures (pain, muscle endurance and functional disability)
Both the groups will receive the given treatment for total duration of 3 days/week for 6 weeks.
|
| Comparator Agent |
progressive postural control exercise versus core strengthening exercise |
Participants for my study will be recruited from institutes of parul university.
All the participants with chronic non specific low back pain will be screened for inclusion criteria.
Ones falling into the inclusion criteria will be recruited and asked to sign the consent form. subjects will have complete freedom to refuse from participating in the study.
Once the consent form is signed the subjects will then be divided into two groups, group a (progressive postural control exercise) & group b (core strengthening).
All the participants will be assessed and for outcome measures (pain, muscle endurance and functional disability)
Both the groups will receive the given treatment for total duration of 3 days/week for 6 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals diagnosed with non-specific chronic low back pain, with a duration of at least 12 weeks.
2.Participants in a stable health condition, without any acute or severe medical comorbidities that could affect their ability to participate in the exercise interventions
3.Medical diagnosis of non-specific LBP with pain and symptoms persisting for more than 3 months
4.Numerical pain rating scale (NPRS) more than 3 cm.
5.No history of lumbar disc herniation or trauma.
|
|
| ExclusionCriteria |
| Details |
1.Participants with specific underlying spinal pathologies such as spondylolisthesis, spinal stenosis, or osteoporosis
2.Females who are pregnant.
3.Individuals who are unable to actively participate to factors such as physical limitations, cognitive impairments, or language barriers.
4.Individuals who have undergone any physiotherapy treatment before
5.Chronic LBP of traumatic or structural origin or LBP with neurological symptoms or pain radiation in the lower leg(s).
6.Previous back surgery, spinal tumors or infections, or neurological and/or musculoskeletal disorders unrelated to LBP like stroke, Parkinson’s disease, demyelination, multiple sclerosis and so on.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Index
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 1 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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="1"
Months="11"
Days="30" |
|
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
|
Low back pain (LBP) is a common multifactorial disorder around the world . Among the patients with LBP, chronic LBP (CLBP) is the highest incidence rate . The lifetime prevalence of LBP was reported to be as high as 84% and that of CLBP was about 23% . CLBP brings huge burdens to patients with unsatisfactory effects of treatments. Although there has been some progress in the assessment and treatment of this disorder in recent years, obtaining satisfactory effects of treatment for CLBP remains a challenge for researchers and clinicians.
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