Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-13 @ 3:36 PM
Study NCT ID:
NCT01911806
Status:
COMPLETED
Last Update Posted:
2014-08-26
First Post:
2013-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-23', 'studyFirstSubmitDate': '2013-03-30', 'studyFirstSubmitQcDate': '2013-07-28', 'lastUpdatePostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Roland-Morris Disability Questionnaires (RMDQ)', 'timeFrame': 'three months'}], 'primaryOutcomes': [{'measure': 'Pain Scores on the Numerical rating scale', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'Scale of lumbar range of motion measure by Modified - Modified Schober Test', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Back care pillow', 'chronic non-specific low back pain', 'randomized controlled trial'], 'conditions': ['Chronic Nonspecific Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females\n* Age 20 - 69 years old.\n* Patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day\n* Patients with low back pain who have pain for more than 3 months\n* Patients have pain at lower back without refer to leg\n* Patients have moderate to severe pain of numerical rating scale (pain score ≥ 4)\n\nExclusion Criteria:\n\n* Pregnant patients\n* Underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery\n* Patients have Quada equine syndrome\n* Patients with nerve root symptoms (neurological deficit)\n\n 1. Patient have refer pain to leg area of same dermatome is problem.\n 2. Abnormal reflex of lower extremity.\n 3. Muscle weakness of area myotome is problem.'}, 'identificationModule': {'nctId': 'NCT01911806', 'briefTitle': 'Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'orgStudyIdInfo': {'id': 'MRG555S021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Back care pillow & standard physical therapy treatment', 'description': 'standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks \\& back care pillow use during the day for 2 weeks', 'interventionNames': ['Device: Back care pillow', 'Procedure: standard physical therapy treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard physical therapy treatment', 'description': 'standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks', 'interventionNames': ['Procedure: standard physical therapy treatment']}], 'interventions': [{'name': 'Back care pillow', 'type': 'DEVICE', 'description': 'back care pillow is specific size by age groups of standard deviation of the lumbar spinal curvature, in 20-29 years was 51.68 ± 6.94 degrees, in 30-39 years was 59.67 ± 7.02 degrees, in 40-49 years was 63.66 ± 7.62 degrees, in 50-59 years was 65.75 ± 10.85 degrees and in 60-69 years was 64.19 ± 9.69 degrees', 'armGroupLabels': ['Back care pillow & standard physical therapy treatment']}, {'name': 'standard physical therapy treatment', 'type': 'PROCEDURE', 'description': 'standard physical therapy treatment are ultrasound therapy and hot pack', 'armGroupLabels': ['Back care pillow & standard physical therapy treatment', 'standard physical therapy treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'School of physical therapy,Faculty of associated medical science,Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'school of physical therapy,Faculty of associated medical science,Khon Kaen University', 'investigatorFullName': 'Bundit Prommanon', 'investigatorAffiliation': 'Khon Kaen University'}}}}