Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-29 @ 3:17 AM
Study NCT ID:
NCT06064058
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2023-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three Groups:\n\n* Case\n* Palcebo\n* No placebo, no intervention group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2023-09-24', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBA1C', 'timeFrame': '6 months', 'description': 'Diabetes index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Back Pain', 'HBA1C'], 'conditions': ['Back Pain Lower Back Chronic', 'Back Pain', 'Pre Diabetes', 'Diabetes', 'Back Pain, Low']}, 'descriptionModule': {'briefSummary': 'Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. This randomized controlled trial aimed to assess whether reducing HbA1c levels through lifestyle interventions and, along with the correction of vitamin D and magnesium, can alleviate nonspecific back pain in prediabetic patients.', 'detailedDescription': 'The study included 40 patients from an outpatient clinic in Baghdad, evenly divided into intervention and control groups. The intervention group underwent a 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. HbA1c levels were measured, and back pain severity was assessed (through what assessment method ?). The control group received standard care with NSAIDs and acetaminophen for pain management. Assessments were conducted at baseline and at various intervals over a total period of 6 months to evaluate changes in HbA1c levels and back pain intensity.\n\nThis randomized controlled trial provides evidence that reducing HbA1c levels through lifestyle modifications, along with the correction of vitamin D and magnesium, can lead to a reduction in nonspecific back pain intensity and improved functional outcomes in prediabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poor sleep (less than 6 hours per day)\n* chronic back pain\n* Multiple joint pain\n* non-specific back pain\n* HBA1C more than 5.7\n* ability to record the data\n\nExclusion Criteria:\n\n* Not able to record data\n* previous spine surgeries\n* severe OA in knee\n* Spinal stenosis\n* Peripheral vascular diseases\n* Rheumatological diseases\n* Lumbar disc prolapse\n* uncooperative patient'}, 'identificationModule': {'nctId': 'NCT06064058', 'briefTitle': 'Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.', 'interventionNames': ['Dietary Supplement: Ghazwan program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Ordinary painkillers given', 'interventionNames': ['Drug: Standard management']}, {'type': 'NO_INTERVENTION', 'label': 'No Placebo, no intervention group', 'description': 'Nothing was given to them neither 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction nor painkillers.'}], 'interventions': [{'name': 'Ghazwan program', 'type': 'DIETARY_SUPPLEMENT', 'description': '6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.', 'armGroupLabels': ['Interventional group']}, {'name': 'Standard management', 'type': 'DRUG', 'description': 'Standard care with NSAIDs and acetaminophen for pain management', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Dr. Ghazwan A. Hasan Clinic', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Hashim T Hashim, MBChB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Warith Al-Anbiyaa, College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor (MBChB)', 'investigatorFullName': 'Hashim Talib Hashim', 'investigatorAffiliation': 'University of Baghdad'}}}}