Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial

Conditions
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Lower Back Pain

Intervention / Treatment
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* Other: DeSSBack


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Usual care | |
| Experimental: Intervention group<br>DeSSBack (Decision Support System for Low Back Pain) | Other: DeSSBack<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Baseline, 6-months |