Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04959669
Status:
UNKNOWN
Last Update Posted:
2021-07-13
First Post:
2021-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in health status measure for low back pain between baseline and 2-month', 'timeFrame': 'Baseline, 2-months', '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.'}, {'measure': 'Changes in health status measure for low back pain between baseline and 6-month', 'timeFrame': 'Baseline, 6-months', '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month', 'timeFrame': 'Baseline, 2-months', '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.'}, {'measure': 'Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month', 'timeFrame': 'Baseline, 6-months', '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.'}, {'measure': 'Changes in the back pain severity score between baseline and 2-month', 'timeFrame': 'Baseline, 2-months', '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.'}, {'measure': 'Changes in the back pain severity score between baseline and 6-month', 'timeFrame': 'Baseline, 6-months', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Back Pain']}, 'referencesModule': {'references': [{'pmid': '37237425', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nThis study protocol presents the rationale and design of a cluster randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient seeking care for low back pain at the primary care clinic in UMMC\n* Male and female\n* Age 18 years and above\n* Can understand Malay and English\n\nExclusion Criteria:\n\n* Potentially serious pathology (eg: cauda equina compression, inflammatory arthritis, malignancy and etc)\n* Serious co morbidity\n* Psychiatric illness or personality disorder\n* Spinal surgery in the last 6 months\n* Pregnant\n* Already receiving treatment other than primary care for this episode of back pain\n* Inability to attend regular physiotherapy appointments.'}, 'identificationModule': {'nctId': 'NCT04959669', 'acronym': 'DeSSBack', 'briefTitle': 'Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PV041-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'DeSSBack (Decision Support System for Low Back Pain)', 'interventionNames': ['Other: DeSSBack']}], 'interventions': [{'name': 'DeSSBack', 'type': 'OTHER', '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.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'CHIN HAI TEO', 'role': 'CONTACT', 'email': 'teoch@um.edu.my', 'phone': '+60179792669'}, {'name': 'TUN FIRZARA BINTI ABDUL MALIK', 'role': 'CONTACT', 'email': 'tun.firzara@ummc.edu.my', 'phone': '+60146416961'}], 'facility': 'University of Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'CHIN HAI TEO', 'role': 'CONTACT', 'email': 'teoch@um.edu.my', 'phone': '+60179192669'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Dr. Teo Chin Hai', 'investigatorAffiliation': 'University of Malaya'}}}}