Lower Back PainDeSSBackNCT04959669
Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain
A study testing DeSSBack in people with Lower Back Pain, run by University of Malaya at 1 site in Malaysia.
Trial summary
Low back pain is a common health problem where over than half a billion people worldwide suffers from it. In Malaysia, back pain is among the top ten reasons why people see a doctor. Although there are many guidelines available, healthcare professionals still find managing low back pain as challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- DeSSBack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Apr 2021to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient seeking care for low back pain at the primary care clinic in UMMC
- Male and female
- Age 18 years and above
- Can understand Malay and English
Who cannot join
- Potentially serious pathology (eg: cauda equina compression, inflammatory arthritis, malignancy and etc)
- Serious co morbidity
- Psychiatric illness or personality disorder
- Spinal surgery in the last 6 months
- Pregnant
- Already receiving treatment other than primary care for this episode of back pain
- Inability to attend regular physiotherapy appointments.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Centre
Kuala Lumpur, 59100
CHIN HAI TEO, +60179792669, teoch@um.edu.my
TUN FIRZARA BINTI ABDUL MALIK, +60146416961, tun.firzara@ummc.edu.my
About this study
Official title: Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial
Low back pain is a common health problem where over than half a billion people worldwide suffers from it. In Malaysia, back pain is among the top ten reasons why people see a doctor. Although there are many guidelines available, healthcare professionals still find managing low back pain as challenging.
The Decision Support System for Low Back Pain (DeSSBack) has been developed by adopting and re-packaging STaRT system, incorporate with the local clinical practice guidelines and feedback from local experts. It aims to aid healthcare professionals in managing low back pain through a stratified approach.
Read more
The objective of the study is to evaluate the effectiveness of DeSSBack in improving the management of patients with low back pain in a primary care clinic. We hypothesise that the implementation of DeSSBack will improve the outcomes of low back pain patients including quality of life, emotional state and level of pain.
This study protocol presents the rationale and design of a cluster randomized controlled trial.
- Conditions
- Lower Back Pain
- Being tested
- DeSSBack
- 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.
DeSSBackOther
The DeSSBack (Decision Support System for Low Back Pain) is a decision support tool developed in the University of Malaya Medical Centre's (UMMC) electronic medical record system by adopting and re-packaging the STaRT system to suit the local context. It stratifies patients with low back pain to low, medium or high risk, which are then managed differently. The DeSSBack has also been incorporated the local clinical practice guidelines and feedback from local experts.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual care |
| Intervention group | Experimental | DeSSBack (Decision Support System for Low Back Pain) Receives: Other: DeSSBack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in health status measure for low back pain between baseline and 2-month
We are measuring the changes in health status with Rolland Morris Disability Questionnaire (RMDQ). The score ranges from a minimum of 0 to a maximum of 24. Greater levels of disability are reflected by higher scores.
Measured: Baseline, 2-months
Changes in health status measure for low back pain between baseline and 6-month
We are measuring the changes in health status with Rolland Morris Disability Questionnaire (RMDQ). The score ranges from a minimum of 0 to a maximum of 24. Greater levels of disability are reflected by higher scores.
Measured: Baseline, 6-months
Secondary outcomes (4)
Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month
The HADS is a self-assessment questionnaire to assess states of anxiety and depression in the setting of hospital outpatient clinic. The minimum value is 0 and the maximum value is 21 for both anxiety and depression. The higher the score, the worse the outcome is.
Measured: Baseline, 2-months
Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month
The HADS is a self-assessment questionnaire to assess states of anxiety and depression in the setting of hospital outpatient clinic. The minimum value is 0 and the maximum value is 21 for both anxiety and depression. The higher the score, the worse the outcome is.
Measured: Baseline, 6-months
Changes in the back pain severity score between baseline and 2-month
The back pain severity score is a self-assessment score to rate severity of the back pain. Patients would rate their back pain from 0 being no pain at all, to 10 being unbearable pain.
Measured: Baseline, 2-months
Changes in the back pain severity score between baseline and 6-month
The back pain severity score is a self-assessment score to rate severity of the back pain. Patients would rate their back pain from 0 being no pain at all, to 10 being unbearable pain.
Measured: Baseline, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start30 Apr 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Teo Chin Hai, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959669
- Sponsor's protocol ID
- PV041-2019
- Acronym
- DeSSBack
- Status last verified
- Jul 2021
- First submitted
- 23 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tun Firzara AM, Teo CH, Teh SY, Su JY, Mohd Zaini HS, Suhaimi A, Ng WL, Danaee M, Stevenson K, Mallen CD, Ng CJ. Evaluation of an electronic clinical decision support system (DeSSBack) to improve low back pain management: a pilot cluster randomized controlled trial. Fam Pract. 2023 Dec 22;40(5-6):742-752. doi: 10.1093/fampra/cmad044.
PubMed 37237425
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04959669
- Acronym / sponsor ID
- DeSSBack / PV041-2019
- Conditions
- Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Jul 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.
Low back pain is a common health problem where over than half a billion people worldwide suffers from it. In Malaysia, back pain is among the top ten reasons why people see a doctor. Although there are many guidelines available, healthcare professionals still find managing low back pain as challenging.
The Decision Support System for Low Back Pain (DeSSBack) has been developed by adopting and re-packaging STaRT system, incorporate with the local clinical practice guidelines and feedback from local experts. It aims to aid healthcare professionals in managing low back pain through a stratified approach.
The objective of the study is to evaluate the effectiveness of DeSSBack in improving the management of patients with low back pain in a primary care clinic. We hypothesise that the implementation of DeSSBack will improve the outcomes of low back pain patients including quality of life, emotional state and level of pain.
This study protocol presents the rationale and design of a cluster randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual care |
| Intervention group | Experimental | Other: DeSSBackDeSSBack (Decision Support System for Low Back Pain) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient seeking care for low back pain at the primary care clinic in UMMC
- Male and female
- Age 18 years and above
- Can understand Malay and English
Key exclusion criteria (7 listed)
- Potentially serious pathology (eg: cauda equina compression, inflammatory arthritis, malignancy and etc)
- Serious co morbidity
- Psychiatric illness or personality disorder
- Spinal surgery in the last 6 months
- Pregnant
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 |
|---|---|---|
| DeSSBackThe DeSSBack (Decision Support System for Low Back Pain) is a decision support tool developed in the University of Malaya Medical Centre's (UMMC) electronic medical record system by adopting and re-packaging the STaRT system to suit the local context. It stratifies patients with low back pain to low, medium or high risk, which are then managed differently. The DeSSBack has also been incorporated the local clinical practice guidelines and feedback from local experts. | Other | Intervention group |
Primary outcome
Changes in health status measure for low back pain between baseline and 2-month
Time frame: Baseline, 2-months
We are measuring the changes in health status with Rolland Morris Disability Questionnaire (RMDQ). The score ranges from a minimum of 0 to a maximum of 24. Greater levels of disability are reflected by higher scores.
Changes in health status measure for low back pain between baseline and 6-month
Time frame: Baseline, 6-months
We are measuring the changes in health status with Rolland Morris Disability Questionnaire (RMDQ). The score ranges from a minimum of 0 to a maximum of 24. Greater levels of disability are reflected by higher scores.
4 secondary outcomes
Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month
Time frame: Baseline, 2-months
Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month
Time frame: Baseline, 6-months
Changes in the back pain severity score between baseline and 2-month
Time frame: Baseline, 2-months
Changes in the back pain severity score between baseline and 6-month
Time frame: Baseline, 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Derived from this study: PubMed 37237425Tun Firzara AM, Teo CH, Teh SY, Su JY, Mohd Zaini HS, Suhaimi A, Ng WL, Danaee M, Stevenson K, Mallen CD, Ng CJ. Evaluation of an electronic clinical decision support system (DeSSBack) to improve low back pain management: a pilot cluster randomized controlled trial. Fam Pract. 2023 Dec 22;40(5-6):742-752. doi: 10.1093/fampra/cmad044.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeSSBack in people with Lower Back Pain, run by University of Malaya 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHIN HAI TEO (+60179192669, teoch@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in health status measure for low back pain between baseline and 2-month (time frame: Baseline, 2-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959669, which also lists 1 linked publication.
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 13 Jul 2021.