Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-09 @ 10:43 AM
Study NCT ID:
NCT00624533
Status:
COMPLETED
Last Update Posted:
2008-02-27
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of GDS Method for Lumbar Stabilization for Non-Specific Low Back Pain in Primary Care
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': 'D011320', 'term': 'Primary Health Care'}], 'ancestors': [{'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-26', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of pain (VAS)', 'timeFrame': 'At baseline, immediately after intervention,at 3-months and 6-months'}], 'secondaryOutcomes': [{'measure': 'Disability (Oswestry questionnaire) Quality of life (SF-36 questionnaire) Elasticity goniometric test for lumbopelvic region', 'timeFrame': 'At baseline, immediately after intervention,at 3-months and 6-months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low back Pain', 'Physical Therapy Modalities', 'Exercise Movement Techniques', 'Primary Health Care'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '14722416', 'type': 'BACKGROUND', 'citation': 'Kovacs FM, Abraira V, Zamora J, Teresa Gil del Real M, Llobera J, Fernandez C, Bauza JR, Bauza K, Coll J, Cuadri M, Duro E, Gili J, Gestoso M, Gomez M, Gonzalez J, Ibanez P, Jover A, Lazaro P, Llinas M, Mateu C, Mufraggi N, Muriel A, Nicolau C, Olivera MA, Pascual P, Perello L, Pozo F, Revuelta T, Reyes V, Ribot S, Ripoll J, Ripoll J, Rodriguez E; Kovacs-Atencion Primaria Group. Correlation between pain, disability, and quality of life in patients with common low back pain. Spine (Phila Pa 1976). 2004 Jan 15;29(2):206-10. doi: 10.1097/01.BRS.0000107235.47465.08.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial was to assess the effectiveness of GDS Treatment Method for patients with subacute or chronic non-specific low back pain in Primary Care of Spanish National Health Service.', 'detailedDescription': 'Low back pain is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%. It is responsible for a major portion of work absenteeism and is actually among those conditions which generate the greatest expense due to health and labor costs.\n\nThe Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs.\n\nThere is considerable variation in LBP related clinical practice and a considerable number of clinical guidelines have been developed for the management of subacute and chronic LBP patients.\n\nExperience in Primary Care Centers of Madrid shows that physiotherapeutic intervention based on GDS Method for Articular and Muscular Chains is an efficient technique in the treatment of patients with diagnosis of non-specific low back pain compared with conventional physiotherapy treatment in Primary Care based on electrotherapy (TENS and microwave)\n\nCurrently, no randomized studies examining the effects of this method for patients with subacute or chronic non-specific low back pain have been published.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants were required to:\n\n* Be aged 18 years or older;\n* Have been diagnosed with simple mechanical LBP by their doctor and prescribed physiotherapy;\n* Have an impairment secondary to functional overload and/or poor postural habits (patients with certain occupations were excluded if these could act as confounding factors);\n* Not be receiving any other form of treatment;\n* Not be neurologically compromised; and\n* To be in a subacute or chronic stage of LBP exceeding 4 weeks.\n\nExclusion Criteria:\n\nSubjects were excluded if they:\n\n* Showed clear symptoms of depression;\n* Refused to participate;\n* Did not sign the informed consent form;\n* Had any cognitive impairment that would prevent them from following instructions;\n* Were unable to understand Spanish sufficiently to adequately follow instructions;\n* Had the intention of moving from the area;\n* Had any form of contraindication to the physiotherapeutic techniques to be applied to both groups;\n* Had red flags, or warning signs, of serious illness such as cancer, infection, fracture or cauda equinal syndrome;\n* Had yellow flags, or risk factors, for a psychological disorder or had lumbar pain whose main cause was not mechanical.'}, 'identificationModule': {'nctId': 'NCT00624533', 'acronym': 'GDS', 'briefTitle': 'Efficiency of GDS Method for Lumbar Stabilization for Non-Specific Low Back Pain in Primary Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Carlos III Health Institute'}, 'officialTitle': 'Evaluation of the Efficiency of Physiotherapeutic Treatment of Non-Specific Low Back Pain in Primary Care Centers Through GDS Techniques for Articular and Muscular Chains', 'orgStudyIdInfo': {'id': 'PI051650'}, 'secondaryIdInfos': [{'id': 'PI051650'}, {'id': 'LA2007PISINISCIII77'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy)', 'interventionNames': ['Behavioral: Conventional Physical Therapy in Primary Health Care']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Group B was treated with the GDS Method (muscular and articular chains physiotherapy method)', 'interventionNames': ['Behavioral: GDS Method (muscular chains physical therapy method)']}], 'interventions': [{'name': 'GDS Method (muscular chains physical therapy method)', 'type': 'BEHAVIORAL', 'description': 'Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks.', 'armGroupLabels': ['B']}, {'name': 'Conventional Physical Therapy in Primary Health Care', 'type': 'BEHAVIORAL', 'description': 'Conventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices.\n\nConventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Spain/Madrid', 'country': 'Spain', 'facility': 'Complutense University', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'José L Chicharro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carlos III Health Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Agencia Lain Entralgo', 'class': 'OTHER_GOV'}, {'name': 'Public Health Service of Madrid', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Joaquín Arenas Barbero', 'oldOrganization': 'Carlos III Health Institute. General Director for evaluation and research'}}}}