Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 9:06 PM
Study NCT ID:
NCT00974103
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2009-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D059388', 'term': 'Pelvic Girdle 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'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D049590', 'term': 'Postpartum Period'}, {'id': 'D026882', 'term': 'Manipulation, Chiropractic'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-31', 'studyFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2009-09-09', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': '20 weeks after the initial assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low back pain', 'pelvic pain', 'pelvic girdle pain', 'post partum'], 'conditions': ['Pelvic Girdle Pain Post Partum', 'Low Back Pain Post Partum']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.', 'detailedDescription': 'The study is a follow up study to "Prevalence of low back pain and pelvic pain in the pregnant population in Stavanger".'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back and\\\\or pelvic girdle pain during pregnancy\n* Fluent understanding of spoken and written Norwegian\n\nExclusion Criteria:\n\n* hospitalisation due to pain or complications post partum'}, 'identificationModule': {'nctId': 'NCT00974103', 'briefTitle': 'Persistent Low Back and Pelvic Pain 3-6 Months Post Partum', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Stavanger HF'}, 'officialTitle': 'Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum', 'orgStudyIdInfo': {'id': '2009/798'}, 'secondaryIdInfos': [{'id': '2009/798', 'type': 'OTHER', 'domain': 'Regional Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chiropractic treatment, exercise', 'description': 'Chiropractic treatment and exercise', 'interventionNames': ['Other: chiropractic treatment and exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Exercises', 'description': 'Exercise advise', 'interventionNames': ['Other: exercise advise']}], 'interventions': [{'name': 'exercise advise', 'type': 'OTHER', 'otherNames': ['Pregnancy', 'Back pain', 'Exercise', 'Post partum', 'chiropractic'], 'description': 'Exercises', 'armGroupLabels': ['Exercises']}, {'name': 'chiropractic treatment and exercises', 'type': 'OTHER', 'otherNames': ['Manipulation', 'Pregnancy', 'Back pain', 'Exercise', 'Post partum', 'chiropractic'], 'description': 'Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments', 'armGroupLabels': ['Chiropractic treatment, exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4011', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger university hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Jan P Larsen, MD Dr med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helse Stavanger HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Stavanger', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}