Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
Study NCT ID:
NCT04119466
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2019-10-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stabilizing Training in Degenerative Disc Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2019-10-06', 'studyFirstSubmitQcDate': '2019-10-06', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Oswestry Disability Index', 'timeFrame': '15 minutes', 'description': "The Oswestry Disability Index (ODI) is a valid and reliable assessment tool used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten sections concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. After completing, the score is calculated by by summing scores from all sections (total maximum points=50). Total results are calculated as a percentage. The higher the score, the subject's condition is worse.\n\nThe results are interpreted as follows:\n\n0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%:These patients are either bed-bound or exaggerating their symptoms."}, {'measure': 'Range of motion evaluation', 'timeFrame': '15 minutes', 'description': 'Range of motion will be evaluated SpinalMouse®. It is a non-invasive device used for assessing spinal mobility, whose reliability has been confirmed by studies. The measurement records the flexion and extension range of motion, and the test measure the total mobility from maximal flexion to maximal extension. Three measurements will be taken, and for statistical purposes their mean value will be calculated.'}], 'secondaryOutcomes': [{'measure': 'The passive lumbar extension test', 'timeFrame': '10 minutes', 'description': 'The passive lumbar extension test (PLE) is a tool for assessing the instability in the lumbar section of the spine. It is is the most suitable test for detecting lumbar instability, thanks to its excellent diagnostic accuracy, and good reliability'}, {'measure': 'Straight leg raise test', 'timeFrame': '10 minutes', 'description': "Straight leg raise (SLR) test is considered by researchers to be sensitive and specific in diagnosing damage to the peripheral nervous system. The subject's lower limb with the knee extended was passively raised until potential symptoms were triggered, although not more than 60° of flexion in the hip joint, which, according to Kapandji, causes the maximum stretching of nerve structures."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['degenerative disc disease', 'stabilizing training', 'protrusion', 'extrusion'], 'conditions': ['Degenerative Disc Disease', 'Protrusion', 'Extrusion of Migrated Disc', 'Hernia']}, 'referencesModule': {'references': [{'pmid': '26377578', 'type': 'BACKGROUND', 'citation': 'Altinkaya N, Cekinmez M. Lumbar multifidus muscle changes in unilateral lumbar disc herniation using magnetic resonance imaging. Skeletal Radiol. 2016 Jan;45(1):73-7. doi: 10.1007/s00256-015-2252-z. Epub 2015 Sep 16.'}, {'pmid': '23948426', 'type': 'BACKGROUND', 'citation': 'Aluko A, DeSouza L, Peacock J. The effect of core stability exercises on variations in acceleration of trunk movement, pain, and disability during an episode of acute nonspecific low back pain: a pilot clinical trial. J Manipulative Physiol Ther. 2013 Oct;36(8):497-504.e1-3. doi: 10.1016/j.jmpt.2012.12.012. Epub 2013 Aug 12.'}, {'pmid': '17885181', 'type': 'BACKGROUND', 'citation': 'Leone A, Guglielmi G, Cassar-Pullicino VN, Bonomo L. Lumbar intervertebral instability: a review. Radiology. 2007 Oct;245(1):62-77. doi: 10.1148/radiol.2451051359.'}, {'pmid': '24534392', 'type': 'BACKGROUND', 'citation': 'Baek SO, Cho HK, Jung GS, Son SM, Cho YW, Ahn SH. Verification of an optimized stimulation point on the abdominal wall for transcutaneous neuromuscular electrical stimulation for activation of deep lumbar stabilizing muscles. Spine J. 2014 Sep 1;14(9):2178-83. doi: 10.1016/j.spinee.2014.02.016. Epub 2014 Feb 14.'}, {'pmid': '21621724', 'type': 'BACKGROUND', 'citation': "Capra F, Vanti C, Donati R, Tombetti S, O'Reilly C, Pillastrini P. Validity of the straight-leg raise test for patients with sciatic pain with or without lumbar pain using magnetic resonance imaging results as a reference standard. J Manipulative Physiol Ther. 2011 May;34(4):231-8. doi: 10.1016/j.jmpt.2011.04.010. Epub 2011 May 5."}, {'pmid': '18164468', 'type': 'BACKGROUND', 'citation': 'Dagenais S, Mayer J, Haldeman S, Borg-Stein J. Evidence-informed management of chronic low back pain with prolotherapy. Spine J. 2008 Jan-Feb;8(1):203-12. doi: 10.1016/j.spinee.2007.10.021.'}, {'pmid': '24361346', 'type': 'BACKGROUND', 'citation': 'Daghighi MH, Pouriesa M, Maleki M, Fouladi DF, Pezeshki MZ, Mazaheri Khameneh R, Bazzazi AM. Migration patterns of herniated disc fragments: a study on 1,020 patients with extruded lumbar disc herniation. Spine J. 2014 Sep 1;14(9):1970-7. doi: 10.1016/j.spinee.2013.11.056. Epub 2013 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates efficacy of stabilizing training of deep core muscles in the lumbar spine in degenerative disc disease subjects, considering the progression level of degenerative disc disease: protrusion or extrusion.', 'detailedDescription': 'Degenerative disc disease (DDD) is one of the causes of low back pain, and contributes to increasing the socio-economic problem. Depending on the reason for the dysfunction, various classifications describing the level of advancement are used. Literature on the subject commonly uses the division into protrusion and extrusion of the intervertebral disc, as approved by the American Society of Neuroradiology.\n\nStabilizing training is one of the forms of conservative treatment of lumbar pain, alongside manual treatment or techniques from the field of chiropractics or physiotherapy. It is thought that the proper stabilization of this region of the body is crucial for coping with pain.\n\nTherefore, the aim of the study was to assess the effectiveness of stabilizing training of deep core muscles in the lumbar spine in subjects in the age of 20-35 years, considering the progression level of degenerative disc disease: protrusion or extrusion, on the basis of the clinical condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'All the subjects undergo imaging examination in the form of MRI, whose results will be interpreted by a radiologist. Each person will be classified according to the current damage to the intervertebral disc as recommended by the American Society of Neuroradiology: protrusion or extrusion of the intervertebral disc.\n\nInclusion Criteria:\n\n* disc disease located in the lumbar region of the spine confirmed by the MRI\n* subacute stage of the disease\n* age 20-35 years\n\nExclusion Criteria:\n\n* advanced degenerative-deformatory changes of the spine\n* previous fracture of the spine\n* neurologic deficits in lower limbs or pelvis\n* spondylolisthesis\n* transitional vertebra\n* rheumatic diseases'}, 'identificationModule': {'nctId': 'NCT04119466', 'briefTitle': 'Stabilizing Training in Degenerative Disc Disease', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw University of Health and Sport Sciences'}, 'officialTitle': 'Stabilizing Training Effects in Relation With Progression Level in Young Degenerative Disc Disease Individuals', 'orgStudyIdInfo': {'id': 'MED23/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protrusion Group', 'description': '20 session of stabilizing training based on the principles developed by Richardson over four weeks.', 'interventionNames': ['Behavioral: Stabilizing training']}, {'type': 'EXPERIMENTAL', 'label': 'Extrusion Group', 'description': '20 session of stabilizing training based on the principles developed by Richardson over four weeks.', 'interventionNames': ['Behavioral: Stabilizing training']}], 'interventions': [{'name': 'Stabilizing training', 'type': 'BEHAVIORAL', 'description': "The training will include the activation of the lumbar multifidus muscle (m. multifudus) and the transverse abdominal muscle (m. transversus abdominis). The performance of the individual stages of the training will be based on Richardson's methodology. One session will comprise 4 sets in which the patient will be asked to do pelvic tilts (draw-in) with simultaneous full exhalation, thus activating the aforementioned muscle groups in different positions: a) prone b) supine with lower extremities flexed c) quadruped d) standing back to the wall. The subjects will perform 3 series consisting of 10 repeats, each of which will last ca. 10 seconds.", 'armGroupLabels': ['Extrusion Group', 'Protrusion Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-305', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'theMedicine', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Błażej Cieślik, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University School of Physical Education, Wroclaw, Poland'}, {'name': 'Tomasz Kuligowski, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University School of Physical Education, Wroclaw, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw University of Health and Sport Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Błażej Cieślik', 'investigatorAffiliation': 'Wroclaw University of Health and Sport Sciences'}}}}