Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-26 @ 8:08 PM
Study NCT ID:
NCT02518360
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2015-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Treatment in Patients With Low Back Pain: Stabilometry
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': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2015-08-02', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Questionnaire', 'timeFrame': '5 minutes', 'description': 'Improvement of low back pain measured by Oswestry Questionnaire: The results of the lumbar scale Oswestry disability percentage will be obtained. Results of the initial measurement, final month of treatment and compared.'}], 'secondaryOutcomes': [{'measure': 'Centre of Pressure Displacement', 'timeFrame': '5 minutes', 'description': 'Stabilometry used to assess Centre of Pressure Displacement. The stabilometric results will be obtained in percentages. The most important variables are the percentage of load anterior, load posterior, load right side and load left side.\n\nResults of the initial measurement, final month of treatment and compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NON SPECIFIC LOW BACK PAIN', 'OSTEOPATHY', 'FOOT PRESSURE PLATFORM', 'POSTURAL BALANCE'], 'conditions': ['Lower Back Pain']}, 'descriptionModule': {'briefSummary': 'Determine the improvement in nonspecific low back pain patients with osteopathic techniques (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a stabilometric platform (Footscan®).', 'detailedDescription': 'Fifty patients participate in this study (25 experimental group with body adjustment protocol of osteopathy and 25 control group). For a first objective of this study, all the patients determine if the osteopathic approach to the body adjustment approach will improve low back pain (Oswestry Questionnaire). For the second aim, the investigators want to know if there are changes in the distribution of body weight in lower limbs in group experimental and control group, analyzed with a stabilometric platform (Footscan®).\n\nThe experimental group is treated with osteopathy, three sessions (20 minutes/session) and a frequency one session/week. The treatment osteopathic is the body adjustment protocol. In the other hand, the control group made 2 stretching global postures once a week (10 minutes for each posture) for three weeks: the first was for the anterior muscular chain and the second posture to stretch the posterior muscle chain. Before treatment, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.\n\nThe analysis will be made with Statistical Package for the Social Sciences (SPSS Statistics) 22.0'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 65 years.\n* Patients with non-specific low back pain.\n* Patients with alteration in the distribution of loads in a podiatric platform.\n\nExclusion Criteria:\n\n* Specific low back pain diagnosed.\n* Pregnancy.\n* Recent surgery in the last year.\n* Acute musculoskeletal disorders out of the lumbar region.\n* Patients with vestibular and instability problems.\n* Meniere syndrome.\n* Oncologic patients.\n* Patients with manual therapy treatment during the study.'}, 'identificationModule': {'nctId': 'NCT02518360', 'acronym': 'Osteop-COP', 'briefTitle': 'Osteopathic Treatment in Patients With Low Back Pain: Stabilometry', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Effect of Osteopathic Treatment in Patients With Nonspecific Low Back Pain: Stabilometry', 'orgStudyIdInfo': {'id': 'UniversidadMHE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OSTEOPATHIC PROTOCOL', 'description': 'Physiotherapist applies an osteopathic treatment in non-specific low back pain patients.\n\nThe experimental group is treated with osteopathy, three sessions (20 minutes/session) and a frequency one session/week. Osteopathic treatment osteopathic is a body adjustment protocol. This protocol adjusts the musculoskeletal disorders since neck to lower limbs in the experimental group. Before treatment, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.', 'interventionNames': ['Other: Osteopathic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Auto Stretching', 'description': 'The patients realizes stretching protocol: two stretching global postures once a week (10 minutes for each posture) for three weeks: the first is for the anterior muscular chain and the second posture to stretch the posterior muscle chain. Before three stretching, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.', 'interventionNames': ['Other: Auto Stretching']}], 'interventions': [{'name': 'Osteopathic', 'type': 'OTHER', 'otherNames': ['Manual Therapy', 'Muscle chains'], 'description': 'Body adjustment in three sessions (20 minutes/session).', 'armGroupLabels': ['OSTEOPATHIC PROTOCOL']}, {'name': 'Auto Stretching', 'type': 'OTHER', 'otherNames': ['Muscle chains'], 'description': 'The patients realize auto stretching in three sessions (20 minutes/session).', 'armGroupLabels': ['Auto Stretching']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT - PhD', 'investigatorFullName': 'Emilio-José Poveda-Pagán', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}