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

Lower Back Pain Clinical Trial

— DeSSBack  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959669
• Other study ID #: PV041-2019
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: University of Malaya
• Contact: CHIN HAI TEO
• Phone: +60179192669
• Email: teoch[@]um.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

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.

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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