Clinical trial NCT04824846: Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
Official title: An Interventional Study on Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Quality of Life
Keywords: LBP
QOL
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 198
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Comparison of Quality of life in patients with Low back Pain before and after Integrated back pain module delivered.
timeFrame: Change from baseline, 6 weeks, 12 weeks, and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: Ministry of Health Hospital
state: Perak
Study officials:
affiliation: University Science Malaysia
name: Mohd Nazri B Shafei
role: STUDY_CHAIR
References: