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

Primary Purpose

Low Back Pain, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Integrated back pain module (IBPM)
Health Educational Pamphlet.
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring LBP, QOL

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ministry of Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ambulance drivers with received Integrated back pain module (IBPM)

Ambulance drivers with received Health Educational Pamphlet.

Arm Description

Behavioral: Integrated back pain module (IBPM)

Other: Health Educational Pamphlet.

Outcomes

Primary Outcome Measures

Comparison of Quality of life in patients with Low back Pain before and after Integrated back pain module delivered.
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.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2021
Last Updated
May 9, 2023
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04824846
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Quality of Life
Keywords
LBP, QOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulance drivers with received Integrated back pain module (IBPM)
Arm Type
Experimental
Arm Description
Behavioral: Integrated back pain module (IBPM)
Arm Title
Ambulance drivers with received Health Educational Pamphlet.
Arm Type
Other
Arm Description
Other: Health Educational Pamphlet.
Intervention Type
Behavioral
Intervention Name(s)
Integrated back pain module (IBPM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Health Educational Pamphlet.
Intervention Description
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).
Primary Outcome Measure Information:
Title
Comparison of Quality of life in patients with Low back Pain before and after Integrated back pain module delivered.
Description
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.
Time Frame
Change from baseline, 6 weeks, 12 weeks, and 24 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Ambulance Drivers in Malaysia's Hospitals
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohd Nazri B Shafei
Organizational Affiliation
University Science Malaysia
Official's Role
Study Chair
Facility Information:
Facility Name
Ministry of Health Hospital
City
Ipoh
State/Province
Perak
ZIP/Postal Code
31250
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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