| CTRI Number |
CTRI/2025/03/082898 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| 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
|
Effectiveness of Posture Realignment in Reducing Pain, Fatigue, and Improving Kinesthesia & Posture in Work-Related Lower Back Disorders Among Gardeners |
|
Scientific Title of Study
|
Efficacy of posture realignment regimen on pain,fatigue,kinesthesia & posture in work related musculoskeletal disorders(WRMSDs) of lower back among gardeners |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Chaudhary |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
Room no. 13 Department of physiotherapy ,SGT Hospital, Budhera, Gurugram,Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8016440287 |
| Fax |
|
| Email |
mahimachaudhary2712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Sen |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no. 13 Department of Physiotherapy,SGT Hospital Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
9958389234 |
| Fax |
|
| Email |
siddhartha_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Mahima Chaudhary |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
Room no. 13 Department of Physiotherapy,SGT Hospital Gurgaon
Gurgaon
HARYANA
122505
India |
| Phone |
8016440287 |
| Fax |
|
| Email |
mahimachaudhary2712@gmail.com |
|
|
Source of Monetary or Material Support
|
| faculty of Physiotherapy, SGT University, Chandu, budhera 122505 |
|
|
Primary Sponsor
|
| Name |
Mahima Chaudhary |
| Address |
Faculty of Physiotherapy,Shree Guru Gobind Singh Tricentenary University, Budhera
122505 Gurgaon, Haryana ,India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Mahima Chaudhary |
SGT Medical College |
Room No. 13 Department of physiotherapy, SGT Hospital
Gurgaon
HARYANA |
8016440287
mahimachaudhary2712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee faculty of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group- conventional exercise |
knee to chest, quadruped extension, posterior pelvic tilt and cat and camel.
Frequency-10 Rep 6sec hold
Duration-15-20min |
| Intervention |
Postural Realignment regimen |
Anterior chain stretch, posterior chain stretch, glute bridge, prone spinal extension, extended child pose and lying twist
Frequency-5-7rep with 10s hold
Duration-30 min |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 25-60 years
2. Both male and female will be included in this study
3. Participant who was engaged in the regular gardening like activities
4. Having complaints of musculoskeletal pain in lower back of the body
5. Having experienced pain for more than three months with NPRS more than 4
|
|
| ExclusionCriteria |
| Details |
1. Any history of surgery or fracture during the last two years.
2. Participant having any diagnosed lumbar problem like lumbar stenosis, lumbar radiculopathy, disc herniation, fracture, spondylolisthesis etc.
3. Subjects with physical disability, neurodegenerative and heart disease.
4. Subjects with complaints of pain caused by other conditions, such as kidney disease, gall bladder problems, premenstrual syndrome, chest pains and other non-musculoskeletal causes of pain.
5.Subject who was medically unstable. Because medically unstable patient can be confused with the question that can mislead the result of the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain, Fatigue, Posture, Musculoskeletal Disorder.
|
day 1 assessment 6th week assessment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kinesthesia |
day 1 assessment 6th week assessment
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
01/04/2025 |
| 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="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
|
Gardening is a physically demanding occupation that exposes workers to strenuous activities, extreme weather conditions, and environmental hazards such as pesticides and allergens. Tasks like digging, weeding, raking, and carrying heavy equipment require repetitive motions and awkward postures, increasing the risk of work-related musculoskeletal disorders (WRMSDs). Gardeners frequently adopt crouched, kneeling, and bent postures, which contribute to low back pain (LBP), a prevalent occupational health issue linked to disability and absenteeism. Poor posture, particularly in high-flexion activities like squatting and kneeling, exacerbates musculoskeletal strain, leading to fatigue, pain, and long-term injuries. While numerous interventions exist for managing LBP, research on posture realignment regimens specifically for gardeners remains limited. Addressing this gap, the present study aims to evaluate the effectiveness of posture realignment programs in reducing pain, fatigue, and improving kinesthesia and posture in gardeners with WRMSDs. Findings from this research could inform evidence-based strategies to enhance occupational health and well-being in this workforce. Hypothesis: NULL HYPOTHESIS: H01: There is no significant severity found in Work Related Musculoskeletal Disorders of lower back among Gardeners. H02: There is no significant effect of posture realignment regimen on pain in work-related musculoskeletal disorders (WRMSDs) of lower back among gardeners. H03: There is no significant effect of posture realignment regimen on fatigue in work-related musculoskeletal disorders (WRMSDs) of lower back among gardeners. H04: There is no significant effect of posture realignment regimen on kinesthesia in work-related musculoskeletal disorders (WRMSDs)of lower back among gardeners. H05: There is no significant effect of posture realignment regimen on posture in work-related musculoskeletal disorders (WRMSDs)of lower back among gardeners. ALTERNATE HYPOTHESIS: H11: There is significant severity found in Work Related Musculoskeletal Disorders of lower back among Gardeners. H12: There is significant effect of posture realignment regimen on pain in work-related musculoskeletal disorders (WRMSDs) of lower back among gardeners. H13: There is significant effect of posture realignment regimen on fatigue in work-related musculoskeletal disorders (WRMSDs) of lower back among gardeners. H14: There is significant effect of posture realignment regimen on kinesthesia in work-related musculoskeletal disorders (WRMSDs) of lower back among gardeners. H15: There is significant effect of posture realignment regimen on posture in work-related musculoskeletal disorders (WRMSDs)of lower back among gardeners.
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