Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02752620
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2016-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2016-04-23', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '5 weeks', 'description': 'VAS (VISUAL ANALOGUE SCALE)'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': '5 weeks', 'description': 'Oswestry Disability Index 2.0'}, {'measure': 'kinesiophobia', 'timeFrame': '5 weeks', 'description': 'Tampa Scale for Kinesiophobia'}, {'measure': 'Depression', 'timeFrame': '5 weeks', 'description': 'Beck Scale for Depression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteopathic manipulative treatment', 'Chronic nonspecific low back pain', 'low back pain'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain\n\nExclusion Criteria:\n\n* Subjects who have spine fractures,\n* Dislocations\n* Ligament ruptures\n* Muscle ruptures\n* Skin lacerations\n* Sacroiliitis\n* Vertebral osteomyelitis\n* Infection\n* Disc herniations with radicular symptoms\n* Rheumatic disorders\n* Cauda equina syndrome\n* Tumors\n* Referred pain visceral\n* Red flags\n* Lower limb discrepancy greater than 2 cm\n* Several conditions requiring participants to be absent for more than two weeks of activities in the experiment\n* Positioning itself as not volunteer the same.'}, 'identificationModule': {'nctId': 'NCT02752620', 'briefTitle': 'Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain: a Randomized Controlled and Double-blind Trial', 'orgStudyIdInfo': {'id': '46194215.9.0000.5284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment', 'description': 'We selected two types of osteopathic techniques for this study:\n\nTechnical articulation: rhythmic technique with low speed in which the goal is the full gain range of motion.\n\nMyofascial techniques (Neuromuscular): techniques involving lateral stretching, linear, deep pressures and pulls of the origins and insertions aiming at a myofascial relaxation.\n\nSacroiliac articulatory technique; Dorsal articulatory technique; Lumbar paraspinal muscles stretching technique; Lumbar myofascial technique (inhibitory).', 'interventionNames': ['Other: Osteopathic Manipulative Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Therapy', 'description': '2 types of therapeutic exercises techniques were used:\n\n* Stabilization exercises\n* Stretches\n\nStabilization exercises:\n\nBridge on the ball 10 - 15 sec Side plank 10 - 15 sec Front board 10 - 15 sec active mobilization lumbopelvic 3 x 6 rep Squats with the ball on the wall 3 x 8 rep\n\nStatic-passive stretch (2 x 30 sec):\n\nParaspinal; Abdominals; Quadratus lumborum; Hip extenders; Hip flexors; Hip abductors; Hip adductors.', 'interventionNames': ['Other: Exercise Therapy']}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment', 'type': 'OTHER', 'armGroupLabels': ['Osteopathic Manipulative Treatment']}, {'name': 'Exercise Therapy', 'type': 'OTHER', 'armGroupLabels': ['Exercise Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Estácio de Sá University', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Frederico Meirelles, Master /PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UERJ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Estácio S.A.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MEIRELLES, F. O.', 'investigatorFullName': 'Frederico de Oliveira Meirelles', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}