Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05927051
Status:
UNKNOWN
Last Update Posted:
2023-07-03
First Post:
2023-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Exercise in Lumbal Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2023-06-23', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core muscle thickness', 'timeFrame': '2 minutes', 'description': 'Ultrasonographic images of the transversus abdominis (TrA), lumbar multifidus (MF) and Gluteus maximus (G max) muscles will be acquired using B mode (TOSHIBA Aplio 300, Japan).'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1 minute', 'description': 'Pain Severity; It will be evaluated with a 10 cm Visual Analogue Scale (VAS). Patients are told what the numbers on the horizontal line mean, 0 is no pain, 10 is the most severe pain in life, and 5 is moderate pain, and they are asked to describe the severity of their pain on the scale.'}, {'measure': 'Modified Oswerty Inquiry', 'timeFrame': '2 minutes', 'description': 'Functional Disability Measurement; The evaluation will be made using the Turkish version of the Modified Oswestry Inquiry Form. Turkish validity and reliability were determined by Edibe Yakut et al. (2004) by In the evaluation of the Oswestry scale, scoring for each question is A=0 B=1 C=2 D=3 E=4 F=5 points. Questions that the patient does not answer will not be evaluated. Evaluation is made on the basis of the questions answered. Patient score =(Patient score/Maximum possible score)\\*100'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar Disc Herniation', 'McKnezie exercises', 'stabilization exercises'], 'conditions': ['Lumbar Disc Herniation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/19026017/', 'label': 'Optimizing performance by improving core stability and core strength'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/16550447/', 'label': 'Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care'}]}, 'descriptionModule': {'briefSummary': 'Lumbar disc herniation, which causes 5% of all low back pain, is the rupture of the annulus fibrosis in the intervertebral disc in the lumbar region and the protrusion of the nucleus pulposus at various degrees, and as a result, the spinal cord or the nerves arising from it are compressed.Aerobic exercise is one of the most important elements in low back pain rehabilitation.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.The aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH.', 'detailedDescription': "n general, low back pain is defined as pain that negatively affects comfort in the lower back and/or legs. Low back pain lasting less than 6 weeks is defined as acute, 6-12 weeks as subacute, and lasting longer than 12 weeks as chronic low back pain. Depending on the low back pain of the people, the activity level decreases and therefore aerobic fitness is negatively affected. As a result of this negative impact, chronic conditions pose a risk in terms of cardiovascular disease and lead to a decrease in work capacity. Therefore, aerobic exercise is one of the most important elements in low back pain rehabilitation. In our country, training on regular exercise habits and waist protection methods is very low. Most patients do not apply to health institutions unless symptoms become severe.Many studies have shown that individuals with low back pain have low muscle strength of the back extensors and flexors when compared to individuals who do not show symptoms, and that these muscles are strong and their aerobic fitness is high, minimizing trauma-related musculoskeletal damage.\n\nCore stabilization and strengthening has been the subject of research in the 1980s. The purpose of these exercises is to increase trunk stability and aerobic capacity. It is used to find and maintain the neutral position, to reduce ligament, tendon and joint tension, to reduce the load on discs and facet joints, to increase functional stability in low back pain, disc herniation and post-operative rehabilitation of patients.The researchers' studies have shown that ultrasound imaging is reliable in measuring TrA thickness in both healthy subjects and low back patients.\n\nThe aim of this study is to examine the effect of core stabilization exercises on functionality and core muscles in patients with LDH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18 to 65\n* Patients who have diagnosed with LDH\n\nExclusion Criteria:\n\n* Patients who were pregnant\n* diagnosed with malignancy\n* had changes of medical treatment in the last 3 months\n* had dysfunction that limited physical activity such as severe neurological impairment,\n* immobility or cooperation deficits\n* had regular exercise habit (minimally three days in a week)'}, 'identificationModule': {'nctId': 'NCT05927051', 'briefTitle': 'Effects of Exercise in Lumbal Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'Comparison of Different Exercise Types in Patients With Lumbal Disc Herniation', 'orgStudyIdInfo': {'id': '13-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stabilization exercises', 'description': 'Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.', 'interventionNames': ['Other: Stabilization exercises']}, {'type': 'EXPERIMENTAL', 'label': 'McKenzie exercises', 'description': 'McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.', 'interventionNames': ['Other: McKenzie exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Home exercises', 'description': 'Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.', 'interventionNames': ['Other: Home exercises']}], 'interventions': [{'name': 'Stabilization exercises', 'type': 'OTHER', 'description': 'Core stability exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.', 'armGroupLabels': ['Stabilization exercises']}, {'name': 'McKenzie exercises', 'type': 'OTHER', 'description': 'McKenzie exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.', 'armGroupLabels': ['McKenzie exercises']}, {'name': 'Home exercises', 'type': 'OTHER', 'description': 'Home exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks', 'armGroupLabels': ['Home exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Elâzığ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Songül Bağlan Yentür', 'role': 'CONTACT'}], 'facility': 'Songül Bağlan Yentür', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'centralContacts': [{'name': 'Songül Bağlan Yentür', 'role': 'CONTACT', 'email': 'sbyentur@firat.edu.tr', 'phone': '+90 424 2370000'}, {'name': 'Şahin Elbastı', 'role': 'CONTACT', 'email': 'msahin23@hotmail.com', 'phone': '+90 424 2370000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Firat University', 'investigatorFullName': 'Songül Bağlan Yentür', 'investigatorAffiliation': 'Firat University'}}}}