NCT04824846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

March 27, 2021

Last Update Submit

May 9, 2023

Conditions

Keywords

LBPQOL

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline, 6 weeks, 12 weeks, and 24 weeks

Study Arms (2)

Ambulance drivers with received Integrated back pain module (IBPM)

EXPERIMENTAL

Behavioral: Integrated back pain module (IBPM)

Behavioral: Integrated back pain module (IBPM)

Ambulance drivers with received Health Educational Pamphlet.

OTHER

Other: Health Educational Pamphlet.

Other: Health Educational Pamphlet.

Interventions

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 Integrated back pain module (IBPM)

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).

Ambulance drivers with received Health Educational Pamphlet.

Eligibility Criteria

Age20 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAmbulance Drivers in Malaysia's Hospitals
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult ≥ 18 years old.
  • Working experience ≥ 1 year

You may not qualify if:

  • Patients with Uncontrolled Chronic Illness such as Hypertension, Diabetes Mellitus, Osteoarthritis and Gout.
  • Injury or surgery of the spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health Hospital

Ipoh, Perak, 31250, Malaysia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohd Nazri B Shafei

    University Science Malaysia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

July 1, 2021

Primary Completion

May 30, 2022

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations