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

NCT04959669 | Unknown

• 1 other identifier: PV041-2019
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month

  Baseline, 2-months

• Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month

  Baseline, 6-months

• Changes in the back pain severity score between baseline and 2-month

  Baseline, 2-months

• Changes in the back pain severity score between baseline and 6-month

  Baseline, 6-months

Study Arms (2)

Control group

NO INTERVENTION

Usual care

Intervention group

EXPERIMENTAL

DeSSBack (Decision Support System for Low Back Pain)

Other: DeSSBack

Interventions

DeSSBack OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 37237425 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CHIN HAI TEO

CONTACT

+60179192669; teoch@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 13, 2021
• Study Start: April 30, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

MY (1)