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

Primary Purpose

Lower Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
DeSSBack
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Malaya Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

Usual care

DeSSBack (Decision Support System for Low Back Pain)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 23, 2021
Last Updated
July 1, 2021
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT04959669
Brief Title
Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain
Acronym
DeSSBack
Official Title
Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
DeSSBack (Decision Support System for Low Back Pain)
Intervention Type
Other
Intervention Name(s)
DeSSBack
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in health status measure for low back pain between baseline and 2-month
Description
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.
Time Frame
Baseline, 2-months
Title
Changes in health status measure for low back pain between baseline and 6-month
Description
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.
Time Frame
Baseline, 6-months
Secondary Outcome Measure Information:
Title
Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month
Description
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.
Time Frame
Baseline, 2-months
Title
Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month
Description
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.
Time Frame
Baseline, 6-months
Title
Changes in the back pain severity score between baseline and 2-month
Description
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.
Time Frame
Baseline, 2-months
Title
Changes in the back pain severity score between baseline and 6-month
Description
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.
Time Frame
Baseline, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHIN HAI TEO
Phone
+60179192669
Email
teoch@um.edu.my
Facility Information:
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIN HAI TEO
Phone
+60179792669
Email
teoch@um.edu.my
First Name & Middle Initial & Last Name & Degree
TUN FIRZARA BINTI ABDUL MALIK
Phone
+60146416961
Email
tun.firzara@ummc.edu.my

12. IPD Sharing Statement

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

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