| CTRI Number |
CTRI/2024/12/077866 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| 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 compare and check the effect of two exercises one where i am giving back exercise with psychological councelling and in other exercise on physio ball for back pain |
|
Scientific Title of Study
|
To compare the effect of back school program vs swiss ball exercise on pain flexibility and disability among individuals with non specific back pain : A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini Yadav |
| Designation |
MPT scholor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Room no 309 3rd floor department of physiotharapy parul university post limda waghodia gujarat
Vadodara GUJARAT 391760 India |
| Phone |
8147382134 |
| Fax |
|
| Email |
nandinigeeta1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhavana Gadhavi |
| Designation |
Dean and principal |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Room no 309 3rd floor department of physiotharapy parul university post limda waghodia gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhavana Gadhavi |
| Designation |
Dean and principal |
| Affiliation |
Parul institute of physiotherapy |
| Address |
Room no 309 3rd floor department of physiotharapy parul university post limda waghodia gujarat
GUJARAT 391760 India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Room no 309 3rd floor Department of Physiotharapy Parul university post limda waghodia Vadodara 391760 Gujarat India |
|
|
Primary Sponsor
|
| Name |
parul university |
| Address |
room no 309 3 nd floor department of physiotharapy parul university post limda waghodia gujarat |
| 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 Nandini yadav |
Parul university |
Room no 309 3rd floor Department of Physiotharapy Parul University post limda waghodia Vadodara 391760 Gujarat India Vadodara GUJARAT |
8147382134
nandinigeeta1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University(IECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
back school program |
4 days in a week for 4 weeks. |
| Comparator Agent |
swiss ball exercise |
4 days in a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Willingness of subjects
2) Patients diagnosed with non-specific low back pain
3)Patients with minimum to moderate disability up to 40% on MODI
4)Patients with VAS grade of 5 and below
5)Age group between 18- 35 years
6)Both Male and Female |
|
| ExclusionCriteria |
| Details |
1)Spinal tumour or other malignancy.
2)Medicine for psychiatric disorder.
3)Lumbar stenosis spondylitis, spondylolisthesis,
4)Neuromuscular disease of back
5)Presence of any lumbar Spinal or disc pathologies.
6)Presence of any Recent injury or Trauma.
7)Cauda equina syndrome that requires urgent surgery.
8)pregnant patients
9)joint disfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual analog scale |
4 days in a week for 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified oswestry low back pain disability sacle |
1 day , last day in 4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="0" Months="6" Days="0" |
|
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 - NO
|
|
Brief Summary
|
NEED OF STUDY
Low back pain is a prevalent
musculoskeletal condition globally considered a primary cause of years lived
with disability It imposes a significant economic burden due to healthcare
expenses reduced productivity, insurance costs, and sick leave.
Non-specific low back pain is discomfort
in the lower back without a clear identifiable cause and pathology.
Back school programs typically involve
education and exercises aimed at improving back health and function. On the
other hand, Swiss ball exercises are one of the dynamic exercises, and the main principle is to reduce low back
pain by increasing muscle strength,
endurance, balance, and flexibility of the trunk while the individual leans on the Swiss ball. Both the intervention emphasizes on strength flexibility and core and
core activation but back school program include knowledge and awareness through
counselling as well as managing psychosocial aspect of pain so here arises a
need to find out whether managing patient as a whole creates a difference in
outcome or not
Individually, both the Back School Program
and Swiss Ball Stabilization Exercise have shown promise in reducing pain,
improving flexibility, and enhancing functional capacity among individuals with
NSLBP but there is a notable absence of research
exploring the combined effects of these interventions.
However, a comparative assessment of these
interventions is lacking in the current literature. Understanding the relative
efficacy of these interventions is crucial for optimizing treatment outcomes
and informing evidence-based practice in the management of NSLBP. The proposed comparative study aims to
address this gap by directly comparing the effects of the Back School Program
and Swiss Ball Stabilization Exercise on pain, flexibility, and disability
among individuals with NSLBP. By conducting a rigorous comparative analysis,
the study seeks to elucidate whether one intervention is superior to the other
or if both exercises are equally effective. |