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Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals

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ClinicalTrials.gov Identifier: NCT04824846
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Ab Hamid Bin Abas, Universiti Sains Malaysia

Study Description
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Brief Summary:
The study is a community interventional study by using an integrated back pain module (IBPM). The purpose of this study is to find out if the module training has any benefit on Low Back pain among ambulance drivers. The effectiveness of the module is determined by baseline quality of life results compared with after the intervention program completed.

Condition or disease Intervention/treatment Phase
Low Back Pain Quality of Life Behavioral: Integrated back pain module (IBPM) Other: Health Educational Pamphlet. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Interventional Study on Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ambulance drivers with received Integrated back pain module (IBPM)
Behavioral: 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.
Ambulance drivers with received Health Educational Pamphlet.
Other: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Ambulance Drivers in Malaysia's Hospitals
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824846


Contacts
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Contact: Ab Hamid B Abas, Mr +601123823181 hamilah742000@gmail.com
Contact: Mohd Nazri B Shafei, Asso. Prof +60199396949 drnazri@usm.my

Locations
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Malaysia
Ministry of Health Hospital
Ipoh, Perak, Malaysia, 31250
Contact: Sharon Lojikip, Doctor    +60166588825    sharon.lojikip@crcmoh.gov.my   
Contact: Ab Hamid B Abas, Mr    +601123823181    hamilah742000@gmail.com   
Sponsors and Collaborators
Universiti Sains Malaysia
Investigators
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Study Chair: Mohd Nazri B Shafei University Science Malaysia
More Information
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Responsible Party: Ab Hamid Bin Abas, Principal Investigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT04824846    
Other Study ID Numbers: S-UD0020/18(R)
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ab Hamid Bin Abas, Universiti Sains Malaysia:
LBP
QOL
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations