| CTRI Number |
CTRI/2024/12/077791 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pain severity, Physical Performance, and Quality of life in Individuals with Low Back Pain: A Cross-Sectional Analysis |
|
Scientific Title of Study
|
Impact of pain severity on physical performance and quality of life among low back pain subjects: a cross-sectional observational 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 |
Mr S J GHOKKUL |
| Designation |
Under graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai TAMIL NADU 600116 India |
| Phone |
9092324444 |
| Fax |
|
| Email |
t0121020@sriher.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai TAMIL NADU 600116 India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India.
TAMIL NADU 600116 India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri
Ramachandra
Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India. |
| 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 K Soundararajan |
Sri Ramachandra Hospital |
New Block Physiotherapy OPD, ground Floor , Room No 1, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu, India Chennai TAMIL NADU |
9551163416
soundararajan.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Project, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai-600116,Tamil Nadu,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
Subjects identified with LBP.
Age above 18 years including both men and women. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Healthy people.
People with walking aids.
Subjects who had spinal fractures or surgery.
People who are unable to understand instructions due to cognitive impairment.
Individuals who have a medical impairment that affects their ability to walk.
Pain Score of more than 7 in NRS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Timed up and go test (TUG)
Health-related Quality of Life(SF-36 questionnaire)
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric rating scale (NRS) |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
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)
|
18/12/2024 |
| 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 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
|
BACKGROUND It’s common for individuals to experience low back pain (LBP) at some point in their lives, which is typically harmless and lasts for a few days or weeks. LBP affects the lumbar region of the spine, located between the hips and the bottom of the ribcage, and is often associated with muscle tension that limits movement. While the prevalence of LBP varies across populations, disability due to back pain is the leading cause of activity limitation for adults under 45 years old and second only to arthritis for those aged 45 to 65 years old. Prevalence refers to the number of individuals in a defined population who have a specific disease or condition at a given time (Jekel J, Elmore J, Katz D. Epidemiology, Biostatistics, and preventative medicine. Toronto, Ontario, Canada: WB Saunders Co;1996: 20-22). In India, the point, annual, and lifetime prevalence rates of LBP were 48% (95% CI 40-56%), 51% (95% CI 45-58%), and 66% (95% CI 56-75%), respectively, with higher rates among females, rural populations, and elementary workers. However, data on LBP prevalence and risk factors are limited in developing countries like India. Therefore, this study aims to fill this gap by investigating the relationship between pain severity and critical outcomes. AIM: To study the pain severity on performance and quality of life in individuals with Low Back Pain. OBJECTIVE: Primary objective: ➢ To explore the association between pain severity and physical performance. Secondary objectives: ➢ To investigate the pain severity on health-related quality of life(HRQoL) ➢ To examine the effect of LBP using SF-36 Questionnaire and Timed up and go Test(TUG) ➢ To analyze the effect of LBP using the Numeric rating scale(NRS). Need for the Study: While previous research has established the impact of LBP on various aspects of well-being, there remains a gap in understanding how pain severity specifically affects physical performance and quality of life. This study seeks to address this gap by examining the relationship between pain severity and these critical outcomes. Procedure: Institutional Ethical Committee, SRIHER will be obtained and the Study will be registered in the Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once the participant fulfils the inclusion criteria, informed consent will be obtained and all baseline outcome measures will be recorded. The study will measure pain severity in participants using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Next, the participant will perform the Timed Up and Go (TUG) test, which involves standing up from a seated position, walking up to 3 meters, returning to the starting point, and sitting down on a chair while the time is recorded. Finally, the participant will complete a set of questionnaires that assess their Health-Related Quality of Life (HRQoL) using a survey similar to the SF-36.
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