Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-30 @ 8:56 PM
Study NCT ID:
NCT01314157
Status:
COMPLETED
Last Update Posted:
2022-08-01
First Post:
2011-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Os pacientes selecionados foram alocados de forma aleatória através da lista de randomização gerada por computador, foram confeccionados envelopes lacrados e opacos utilizados para manter o segredo de alocação. Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Alocados de forma cega para o grupo de intervenção: 27 pacientes com diagnóstico de lombalgia crônica realizaram o Isostretching e uso de diclofenaco em caso de dor e grupo controle:27 pacientes com lombalgia crônica sem atividade física com uso apenas de diclofenaco em caso dedor Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego. Os pacientes foram instruídos nos dois grupos, pelo médico, a utilizar o diclofenaco de sódio 50mg, a cada oito horas de acordo com a dor.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2011-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-03-11', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of isostretching effects in patients with chronic low back pain', 'timeFrame': '1 month', 'description': 'Reviewed by analog pain scale. (VAS)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'pain', 'incapacity', 'life quality', 'rehabilitation'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Isostretching is effective in treating chronic back pain to improve pain, quality of life and functional capacity.', 'detailedDescription': 'Objective: This study investigated the influence of isostretching on patients with chronic low back pain. Methods: It was a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back pain were randomized to an experimental group and a control group. The experimental group performed isostretching twice a week for 45 days, while the control group remained on the waiting list for physical therapy. Patients were submitted to evaluations at baseline, after 20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and satisfaction. Results: The experimental group exhibited statistically significant improvements in comparison to the control group with regard to pain (p = .003), functional capacity (p = .026), patient satisfaction (p \\< .001), and quality of life as determined by the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales of the SF-36. The experimental group used a significantly lesser amount of pain medication than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain and in improving function, patient satisfaction and some aspects of quality of life in patients with chronic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with chronic low back pain with pain located between the last rib and the gluteal fold over 12 weeks;\n* Mechanical back pain that worsens with exertion and relieved by rest;\n* Pain between 3 and 8 cm measured by analog pain scale.\n\nExclusion Criteria:\n\n* Subjects who presented pain root\n* Fibromyalgia\n* Severe scoliosis with abnormal alignment of the spine (Cobb angle\\> 40); Tumors in the column; Infiltration in the lumbar spine in the last three months; Previous surgery of the spine (patients return to work or process expulsion)\n* Have changed or initiated physical activity in the last three months\n* Body mass index greater than 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT01314157', 'briefTitle': 'Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Evaluation of Isostretching Effects in Patients With Mechanical and Postural', 'orgStudyIdInfo': {'id': '1-Prado'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physiotherapy treatment technique', 'description': 'Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with "technical isostretching"', 'interventionNames': ['Other: Isostretching']}, {'type': 'NO_INTERVENTION', 'label': 'Patients remained on the waiting list', 'description': 'Randomized clinical trial controlling and using at the time of allocation, toss with sealed envelopes, sealed and opaque. The study group will be dealt with control group.'}], 'interventions': [{'name': 'Isostretching', 'type': 'OTHER', 'otherNames': ['Strengthening and stretching exercise during expiration.'], 'description': '12 interventions (two times per week) for 45 minutes', 'armGroupLabels': ['Physiotherapy treatment technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57051-540', 'city': 'Maceió', 'state': 'Alagoas', 'country': 'Brazil', 'facility': 'Erika Rosangela Alves Prado', 'geoPoint': {'lat': -9.66583, 'lon': -35.73528}}], 'overallOfficials': [{'name': 'Erika Rosângela A Prado, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual de Ciências da Saúde de Alagoas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mestra em Ciências da Saúde Aplicada a Medicina Reumatológica', 'investigatorFullName': 'Erika Rosangela Alves Prado', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}