- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04824846
Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
An Interventional Study on Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An integrated back pain module (IBPM) will be implemented for ambulance drivers (Respondent) in peninsular Malaysia. Pre-intervention assessment and post-intervention assessment will be conducted in 18 government hospitals involved. There is nine Hospital in Perak that has been selected as an intervention group and nine Hospital in Kelantan will be the Control group. Two different regions are selected; the North region will be the intervention group (Perak) while East Coast will be the control group (Kelantan). The clinical benefits of the IBPM module low back pain and quality of life will be reported at the beginning and the end of the intervention and after a period of 6 months follow up.
The protocol for the intervention group (Perak) included five components of the education module (IBPM) such as the structure and function of the spine, causes of LBP, how to avoid low back pain at the workplace, Exercise methods, and psychology management. The overall objectives are to help ambulance driver manage their LBP and prevent future LBP recurrences. The first step of the protocol is subjects are required to attend an introductory course for one day and then the intervention will last for 6 months. Research staff will explain how to operate and use the module. Subjects must comply with all the care and prevention guidelines of the research module so that it achieves the expected results. They also need to complete the checklist provided in the Edmodo software via their respective smartphones. Tokens in the form of top-ups will be entered automatically after the checklist is received by researchers.
The exercise will be performed by participants 5 times per week for a total of 24 weeks. Each individual session will take around 5 minutes to perform exercises independently and sending their report through Edmodo. Light soft tissue exercises techniques such as active muscle stretching, and strengthening exercises will be used as needed to facilitate the educational module therapy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ab Hamid B Abas, Mr
- Phone Number: +601123823181
- Email: hamilah742000@gmail.com
Study Contact Backup
- Name: Mohd Nazri B Shafei, Asso. Prof
- Phone Number: +60199396949
- Email: drnazri@usm.my
Study Locations
-
-
Perak
-
Ipoh, Perak, Malaysia, 31250
- Ministry of Health Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult ≥ 18 years old.
- Working experience ≥ 1 year
Exclusion Criteria:
- Patients with Uncontrolled Chronic Illness such as Hypertension, Diabetes Mellitus, Osteoarthritis and Gout.
- Injury or surgery of the spine
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: Ambulance drivers with received Integrated back pain module (IBPM)
Behavioral: Integrated back pain module (IBPM)
|
All Ambulance drivers will be screening with the Proforma to determine their low back pain symptoms.
Those workers who are diagnosed with mechanical back pain during the 12 months fulfill a self-report quality of life questionnaire (SF-36).
Then Integrated back pain module (IBPM) will be delivered to them after the introduction course conducted for 1 day and then the intervention will last for 6 months.
Research staff will explain how to operate and use the module.
Subjects must comply with all the care and prevention guidelines of the research module so that it achieves the expected results.
They also need to complete the checklist provided in the Edmodo software via their respective smartphones.
|
Other: Ambulance drivers with received Health Educational Pamphlet.
Other: Health Educational Pamphlet.
|
In Health Educational Pamphlet (HEP) sessions, Participants will be taught the importance of movement and activity, pain management techniques, and methods for developing spinal posture awareness during activities of daily living (e.g., lifting, pushing, pulling, sitting, getting out of bed, and using a backpack).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Quality of life in patients with Low back Pain before and after Integrated back pain module delivered.
Time Frame: Change from baseline, 6 weeks, 12 weeks, and 24 weeks
|
Quality of life was assessed by Short-Form 36 Health Survey (SF-36) High scores indicate good quality of life and low scores represent poor quality of life.
|
Change from baseline, 6 weeks, 12 weeks, and 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohd Nazri B Shafei, University Science Malaysia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-UD0020/18(R)
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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