Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 10:44 AM
Study NCT ID:
NCT06756516
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-31', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2024-12-31', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance', 'timeFrame': 'Baseline and 5 weeks.', 'description': 'Using Biodex Balance System 3 parameters will be assessed. Overall stability Mediolateral stability Anteroposterior stability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feldenkrais method', 'mechanical low back pain', 'balance'], 'conditions': ['Mechanical Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Feldenkrais method affects balance in patients with mechanical low back pain. The main questions it aims to answer is:\n\ndoes Feldenkrais method affects balance in patients with mechanical low back pain.\n\nParticipants will:\n\nBe assessed for inclusion using slump and straight leg raise tests. Visit the clinic twice every week for sessions. Assessed pre and post treatment using Biodex Balance.', 'detailedDescription': 'Sample size calculation showed that our sample is 40. Forty patients with mechanical low back pain not referring beyond the knee will be recruited from Souad Kafafi Hospital and multiple outpatient clinics in Giza, Egypt. Inclusion criteria is male or female patients, 18-45 years, mechanical pain for the last 6 months, with no previous surgeries or diseases in the spine. Treatment strategy include 10 treatment sessions for each allocated subject. Core strengthening exercises and Feldenkrais method (balance exercises) are the treatment approached used in this study. Two experienced physical therapists will apply the treatment in the Faculty of Physical therapy clinic. Overall, mediolateral, and anteroposterior stability will be assessed for each patient. The measurement will be done twice pretreatment and immediately after the last session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical back pain.\n* Symptoms lasted for the last 6 months.\n* Not referring beyond the knee.\n* Mild to moderate pain in Numerical Pain Rating Scale and mild to moderate disability on Oswestry Disability Index\n\nExclusion Criteria:\n\n* Spine Surgeries\n* Chronic diseases\n* Accidents and Fractures'}, 'identificationModule': {'nctId': 'NCT06756516', 'briefTitle': 'Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Misr University for Science and Technology'}, 'officialTitle': 'Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feldenkrais Method balance exercises', 'description': 'Balance exercises in Feldenkrais method plus core stability exercises', 'interventionNames': ['Other: Feldenkrais Method and Core stabilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Core stability exercises only', 'description': 'Core strengthening exercises to engage global and local stabilizers of the spinal column as Bridging exercises, Side bridging exercise, plank, side plank, McGill Abdominal exercises.\n\nEach exercise will be repeated for 3 sets with 8 repetitions with hold for 5 seconds.', 'interventionNames': ['Other: Core stability exercises']}], 'interventions': [{'name': 'Feldenkrais Method and Core stabilization', 'type': 'OTHER', 'description': 'Balance exercises from supine lying position using Feldenkrais style, plus core stabilization exercises.', 'armGroupLabels': ['Feldenkrais Method balance exercises']}, {'name': 'Core stability exercises', 'type': 'OTHER', 'description': 'trunk deep muscles activation and engaging using exercises as bridging, side bridging, plank, side plank and McGill Abdominal', 'armGroupLabels': ['Core stability exercises only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12582', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shaimaa N AboElazm, Dean', 'role': 'CONTACT', 'email': 'shaimaa.nabil@must.edu.eg', 'phone': '+201001779151'}, {'name': 'Mohamed E Fahmy, Instructor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Misr University for Science and Technology', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mohamed E Fahmy, Instructor', 'role': 'CONTACT', 'email': 'mohamed.khater@must.edu.eg', 'phone': '+201114650668'}, {'name': 'Aya A Khalil, Lecturer', 'role': 'CONTACT', 'email': 'aya.abdelhamied@pt.cu.edu.eg', 'phone': '+20 11 12204944'}], 'overallOfficials': [{'name': 'Neveen A Abdelraouf, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University Faculty of Physical Therapy'}, {'name': 'Aya A Khalil, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University Faculty of Physical Therapy'}, {'name': 'Shereen M Said, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Misr University for Science and Technology'}, {'name': 'Mohamed E Fahmy, Instructor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr University for Science and Technology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the date of publication of this work by 3 months.', 'ipdSharing': 'YES', 'description': 'Study protocol will be shared by the principal investigator using email address mohamed.khater@must.edu.eg upon request.', 'accessCriteria': 'The requests will be assessed by the principal investigator. The data will be sent by the formal email address.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching assistant Biomechanics department', 'investigatorFullName': 'Mohamed Emad Fahmy Mohamed', 'investigatorAffiliation': 'Misr University for Science and Technology'}}}}