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

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.

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 Overview

• Status: Recruiting
• Conditions: Lower Back Pain
• Intervention / Treatment: Other: DeSSBack

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin Hai Teo; Phone Number: +60179192669; Email: teoch@um.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University of Malaya Medical Centre
    • Contact: CHIN HAI TEO; Phone Number: +60179792669; Email: teoch@um.edu.my
    • Contact: TUN FIRZARA BINTI ABDUL MALIK; Phone Number: +60146416961; Email: tun.firzara@ummc.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care
Experimental: Intervention group; DeSSBack (Decision Support System for Low Back Pain)	Other: DeSSBack; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PV041-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No