Low Back PainNCT04824846
Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
A study testing Integrated back pain module (IBPM) and Health Educational Pamphlet. in people with Low Back Pain and Quality of Life, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Low Back Pain, Quality of Life
- What is being tested?
- Integrated back pain module (IBPM) and Health Educational Pamphlet.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adult ≥ 18 years old.
- Working experience ≥ 1 year
Who cannot join
- Patients with Uncontrolled Chronic Illness such as Hypertension, Diabetes Mellitus, Osteoarthritis and Gout.
- Injury or surgery of the spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Study on Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
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.
Read the 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.
- Conditions
- Low Back Pain, Quality of Life
- Being tested
- Integrated back pain module (IBPM), Health Educational Pamphlet.
- Keywords
- LBP, QOL
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated back pain module (IBPM)Behavioural
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.
Health Educational Pamphlet.Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Ambulance drivers with received Integrated back pain module (IBPM) | Experimental | Behavioral: Integrated back pain module (IBPM) Receives: Behavioral: Integrated back pain module (IBPM) |
| Ambulance drivers with received Health Educational Pamphlet. | Other | Other: Health Educational Pamphlet. Receives: Other: Health Educational Pamphlet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline, 6 weeks, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jul 2021
- Primary completion30 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ab Hamid Bin Abas, Universiti Sains Malaysia
- Investigators
- Mohd Nazri B Shafei, Study chair, University Science Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824846
- Sponsor's protocol ID
- S-UD0020/18(R)
- Status last verified
- May 2023
- First submitted
- 27 Mar 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study on Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals
- ClinicalTrials.gov ID
- NCT04824846
- Acronym / sponsor ID
- S-UD0020/18(R)
- Conditions
- Low Back Pain, Quality of Life
- Keywords
- LBP, QOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult ≥ 18 years old.
- Working experience ≥ 1 year
Key exclusion criteria (2 listed)
- Patients with Uncontrolled Chronic Illness such as Hypertension, Diabetes Mellitus, Osteoarthritis and Gout.
- Injury or surgery of the spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Ambulance drivers with received Integrated back pain module (IBPM) |
| 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). | Other | Ambulance drivers with received Health Educational Pamphlet. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohd Nazri B Shafei study chair
University Science Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated back pain module (IBPM) and Health Educational Pamphlet. in people with Low Back Pain and Quality of Life, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.