Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 7:54 AM
Study NCT ID:
NCT01772433
Status:
UNKNOWN
Last Update Posted:
2013-01-21
First Post:
2013-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olive Oil Phonophoresis and Chronic Low Back
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety', 'timeFrame': 'Day 10', 'description': 'Any occurrence of drug induced side effects will be recorded'}], 'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Change from Baseline in McGill Low Back Pain Scale at day 10', 'description': 'Low back pain intensity will be measured using McGill questionnaire from 0 (no pain) to 10 (worst).'}], 'secondaryOutcomes': [{'measure': 'Physical function', 'timeFrame': 'Change from Baseline in Phycical Function Scale at Day 10', 'description': 'The ability of patients in doing daily activities will be measured using two qualified questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low Back Pain', 'Topical Olive Oil', 'Phonophoresis'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back pain in female athletes.', 'detailedDescription': 'This study will enroll 60 female patients suffering from chronic low back pain. the study will run in single blind mode that only patients will kept unaware of treatment.\n\nThe duration of treatment is 10 days. patients will be assigned randomly to olive oil or placebo group. every day, they will take phonophoresis on lower back using phonophoresis gel as placebo or olive oil as treatment for 10 day. the questionnaires will be filled in baseline visit and day 10. any side effect of drugs or technique will be recorded'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young female athletes suffering from low back pain for more than three months\n\nExclusion Criteria:\n\n* Underlying systematic or visceral disease\n* Specific conditions such as neoplasm and fractures, spondylolisthesis\n* Previous low back surgery\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01772433', 'briefTitle': 'Olive Oil Phonophoresis and Chronic Low Back', 'organization': {'class': 'OTHER', 'fullName': 'Ardabil University of Medical Sciences'}, 'officialTitle': 'The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1391/7/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Phonophoresis Gel', 'description': 'The Phonophoresis gel will be used as placebo', 'interventionNames': ['Drug: Phonophoresis gel']}, {'type': 'EXPERIMENTAL', 'label': 'Olive Oil', 'description': 'Olive oil will be used as a replacement to phonophoresis gel in this arm', 'interventionNames': ['Dietary Supplement: Olive oil']}], 'interventions': [{'name': 'Olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Phonophoresis with Olive oil for 10 day, daily', 'armGroupLabels': ['Olive Oil']}, {'name': 'Phonophoresis gel', 'type': 'DRUG', 'description': 'Phonophoresis with base gel for 10 days, daily', 'armGroupLabels': ['Phonophoresis Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56197', 'city': 'Ardabil', 'state': 'Ardabil Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Shahab Bohlooli, PhD', 'role': 'CONTACT', 'email': 'shahab.bohlooli@arums.ac.ir'}, {'name': 'Babak Nakhostin-roohi, PhD', 'role': 'CONTACT', 'email': 'bnakhostin_aau@yahoo.com'}, {'name': 'Babak Nakhostin-roohi, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shahab Bohlooli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic of Physiotherpay', 'geoPoint': {'lat': 38.2498, 'lon': 48.2933}}], 'centralContacts': [{'name': 'Shahab Bohlooli, PhD', 'role': 'CONTACT', 'email': 'shahab.bohlooli@arums.ac.ir'}], 'overallOfficials': [{'name': 'Shahab Bohlooli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pharmacology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardabil University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Islamic Azad University, Sanandaj', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Shahab Bohlooli', 'investigatorAffiliation': 'Ardabil University of Medical Sciences'}}}}