- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250568
Office Program Effects on Pain, Posture, Muscle Physiology, Stress, Ergonomics, and Quality of Life in LBP Workers
Effects of Exercise, Posture Education, and Standing Advice on Pain, Lumbar Posture, Core Stability, Flexibility, Fatigue, Endurance, Ergonomics, Stress, and Quality of Life in Office Workers With Low Back Pain: A Three-Arm RCT
This interventional study aims to evaluate the effectiveness of an office worker's program in reducing low back pain and improving physical and psychosocial outcomes among office employees. The primary objective is to determine the effects of the intervention on pain, lumbar posture, muscle physiology (including core stability, flexibility, fatigue, and endurance), ergonomics, stress levels, and quality of life across different intervention groups.
Participants will be assigned to one of three groups:
Group 1: Exercise program, posture education, and standing advice Group 2: Posture education and standing advice Group 3: standing advice only The study will compare outcomes between groups to identify which combination of interventions provides the greatest benefits for office workers with a tendency to experience low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Suci Wahyu Ismiyasa
- Phone Number: +6285219163441
- Email: suciwahyuismiyasa@gmail.com
Study Contact Backup
- Name: Zarina Zahari, PhD
- Phone Number: +6013204170
- Email: zarinazahari@uitm.edu.my
Study Locations
-
-
West Java
-
Depok, West Java, Indonesia, 16514
- Recruiting
- Universitas Pembangunan Nasional Veteran Jakarta
-
Contact:
- Suci Wahyu Ismiyasa
- Phone Number: +6285219163441
- Email: suciwahyuismiyasa@gmail.com
-
Contact:
- Zarina Zahari, Phd
- Phone Number: +6013-2094170
- Email: zarinazahari@uitm.edu.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identified LBP
- Age between 18 - 60 years old
- In the office, working in front computer/laptop minimum along 4 hours per day
- Able to ambulate independently with or without walking aids
- Controlled comorbidity e.g. DM, HPT, managed asthma and controlled thyroid conditions
Exclusion Criteria:
- Recumbent
- Cancer, spinal fracture, neurological disorder (stroke, PBI and soon)
- Participation in a current fitness program designed to prevent LBP recurrence
- Spinal operation within the last six months
- Pregnant
- Medication (steroid therapy, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, muscle relaxants, antidepressants or anxiolytics)
- Insufficient to finish outcome measurements and exercise program
- Participants who do not attend 3 consecutive weeks or 8 consecutive times
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Group
Participants in this arm will receive a structured exercise program supervised by a physiotherapist, combined with posture education using an illustrated poster and regular standing advice.
The exercise program consists of progressive abdominal and lumbar strengthening exercises performed 3 times per week for 12 weeks, with each session lasting approximately 20 minutes.
|
Exercise Program: A structured physiotherapist-supervised exercise program designed to improve core stability, lumbar strength, flexibility, and endurance.
The program includes progressive abdominal and lumbar muscle strengthening exercises performed three times per week for 12 weeks, with each session lasting approximately 20 minutes.
Exercises gradually increase in intensity based on participant tolerance and progression criteria.
An educational ergonomic intervention delivered using an illustrated posture guidance poster.
Participants receive instruction on proper sitting posture, workstation alignment, neutral spine position, and strategies to reduce lumbar strain during daily office activities.
Education is delivered at baseline with follow-up reminders throughout the 12-week study period.
Other Names:
A behavioral intervention in which participants are advised to take regular standing breaks to reduce prolonged sitting.
Participants are instructed to stand for short intervals periodically during working hours, supported by scheduled reminders.
No exercise or posture education materials are included in this intervention.
|
|
Active Comparator: Education Group
Participants in this arm will receive posture education supported by an illustrated poster and regular standing advice.
No exercise program will be provided to this group.
|
An educational ergonomic intervention delivered using an illustrated posture guidance poster.
Participants receive instruction on proper sitting posture, workstation alignment, neutral spine position, and strategies to reduce lumbar strain during daily office activities.
Education is delivered at baseline with follow-up reminders throughout the 12-week study period.
Other Names:
A behavioral intervention in which participants are advised to take regular standing breaks to reduce prolonged sitting.
Participants are instructed to stand for short intervals periodically during working hours, supported by scheduled reminders.
No exercise or posture education materials are included in this intervention.
|
|
Active Comparator: Control Group
Participants in this arm will receive standing advice only, without exercise intervention or posture education materials.
|
A behavioral intervention in which participants are advised to take regular standing breaks to reduce prolonged sitting.
Participants are instructed to stand for short intervals periodically during working hours, supported by scheduled reminders.
No exercise or posture education materials are included in this intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale for pain
Time Frame: Baseline and Week 12
|
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst possible pain).
Participants will rate their average low back pain at baseline and after the 12-week intervention.
Changes in NRS scores will be compared across groups.
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flexible curve to measure Lumbar posture
Time Frame: Baseline and Week 12
|
Lumbar posture will be assessed using the Flexible Curve method, which measures lumbar curvature by molding a flexible ruler along the participant's lumbar spine.
Measurements will be taken in the prone position to assess lumbar extension and in the sitting position to assess lumbar flexion.
The molded curve will then be traced onto paper to calculate the lumbar lordosis angle and curvature index.
Changes in lumbar curvature values will be compared between groups to determine the effects of the interventions on spinal alignment.
The unit of measurement will be degrees.
|
Baseline and Week 12
|
|
Sphygmomanometer Pressure Test to measure Core Stability
Time Frame: Baseline and Week 12
|
Core stability will be assessed using a sphygmomanometer pressure biofeedback test.
Participants will be positioned sitting, with the cuff placed behind the lumbar region and inflated to a baseline pressure of 40 mmHg.
Changes in pressure during controlled abdominal drawing-in maneuvers will be recorded.
Smaller pressure deviations indicate better core muscle activation and stability.
Core stability scores will be compared between groups to evaluate the effectiveness of each intervention.
The unit of measurement will be millimeters of mercury (mmHg).
|
Baseline and Week 12
|
|
Short Form-36 (SF-36) to measure quality of life
Time Frame: Baseline and Week 12
|
Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, which measures eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Each domain is scored from 0 to 100, with higher scores indicating better health status.
Changes in SF-36 scores will be compared between groups to determine the impact of the interventions on overall quality of life.
|
Baseline and Week 12
|
|
Perceived Stress Scale (PSS) to measure stress
Time Frame: Baseline and Week 12
|
Stress levels will be assessed using the Perceived Stress Scale (PSS), a validated self-report questionnaire that measures the degree to which situations in a participant's life are appraised as stressful.
Participants complete the 10-item PSS, with each item scored on a 0-4 scale.
Higher total scores indicate higher perceived stress.
Changes in PSS scores will be compared between the three study groups to evaluate the effect of the interventions on stress reduction.
|
Baseline and Week 12
|
|
Rapid Office Strain Assessment (ROSA) to measure ergonomics
Time Frame: Baseline and Week 12
|
Ergonomic risk will be evaluated using the Rapid Office Strain Assessment (ROSA), a validated observational tool designed to assess risk factors associated with office workstation setup.
The ROSA score is calculated based on chair design, monitor height, keyboard/mouse position, posture, and duration of exposure to each risk factor.
Higher scores indicate greater ergonomic risk.
Changes in ROSA scores will be compared between groups to determine whether the interventions improve workstation ergonomics and reduce musculoskeletal risk factors.
|
Baseline and Week 12
|
|
Lumbar Trunk Muscle Endurance Tests to measure endurance
Time Frame: Baseline and Week 12
|
Lumbar trunk muscle endurance will be assessed using three standardized endurance tests, the unit of measurement per item will be second:
Longer hold times indicate better muscle endurance. Changes in endurance times will be compared between groups to determine the effectiveness of the interventions. |
Baseline and Week 12
|
|
Surface Electromyography (sEMG) to measure muscle fatigue
Time Frame: Baseline and Week 12
|
Muscle fatigue will be assessed using surface electromyography (sEMG) recorded from the lumbar extensor muscles during a standardized isometric contraction task.
sEMG signals will be analyzed for median frequency (MF) and root mean square (RMS) changes.
A decrease in MF and an increase in RMS over time indicate greater muscle fatigue.
Differences in sEMG-derived fatigue indicators will be compared between intervention groups to determine the effect of the programs on lumbar muscle fatigue.
The unit of measurement will be microvolts (µV).
|
Baseline and Week 12
|
|
Sit-and-Reach Test to measure flexibility
Time Frame: Baseline and Week 12
|
Flexibility will be assessed using the Sit-and-Reach Test, which measures hamstring and lower back flexibility.
Participants sit on the floor with legs extended and reach forward along a standardized measurement box.
The distance reached (in centimeters) is recorded, with greater reach indicating better flexibility.
Changes in Sit-and-Reach scores will be compared between groups to evaluate the effects of the interventions on flexibility.
The unit of measurement will be centimeters.
|
Baseline and Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suci Wahyu Ismiyasa, M.Erg, Universiti Teknologi Mara
- Study Director: Zarina Zahari, PhD, Universiti Teknologi Mara
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Low Back Pain
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Health Services
- Health Care Facilities Workforce and Services
- Community Health Services
- Socioeconomic Factors
- Population Characteristics
- Behavioral Disciplines and Activities
- Mental Health Services
- Exercise
- Educational Status
- Counseling
Other Study ID Numbers
- UTMara-OWP-LBP2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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