Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05503758
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2022-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomechanical Properties of the Lumbar Paravertebral Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2022-08-13', 'studyFirstSubmitQcDate': '2022-08-13', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumbar paravertebral muscle frequency (tone)', 'timeFrame': 'Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device', 'description': "Tone is a contractile property of a muscle which describes the resting muscle's resistance to passive and active stretch forces"}, {'measure': 'Lumbar paravertebral muscle stiffness', 'timeFrame': 'Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device', 'description': "Stiffness is a biomechanical property of a muscle and its connective tissue which refers to the tissue's resistance toward the deformation of external load"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Paravertebral Muscles']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Iddrisu M, Khan ZH. Anesthesia for cesarean delivery: general or regional anesthesia-a systematic review. Ain-Shams Journal of Anesthesiology. 2021 Dec;13(1):1-7.'}, {'pmid': '30985305', 'type': 'BACKGROUND', 'citation': 'Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.'}, {'pmid': '30459029', 'type': 'BACKGROUND', 'citation': 'Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9.'}, {'pmid': '34721664', 'type': 'BACKGROUND', 'citation': 'Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.'}, {'pmid': '28005829', 'type': 'BACKGROUND', 'citation': 'Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.'}, {'type': 'BACKGROUND', 'citation': 'Sung, S., and Mahdy, H. (2021):'}, {'pmid': '31151377', 'type': 'BACKGROUND', 'citation': 'Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.'}, {'pmid': '35248290', 'type': 'BACKGROUND', 'citation': 'Hamilton RI, Garden CLP, Brown SJ. Immediate effect of a spinal mobilisation intervention on muscle stiffness, tone and elasticity in subjects with lower back pain - A randomized cross-over trial. J Bodyw Mov Ther. 2022 Jan;29:60-67. doi: 10.1016/j.jbmt.2021.09.032. Epub 2021 Oct 9.'}, {'pmid': '31759390', 'type': 'BACKGROUND', 'citation': 'Lo WLA, Yu Q, Mao Y, Li W, Hu C, Li L. Lumbar muscles biomechanical characteristics in young people with chronic spinal pain. BMC Musculoskelet Disord. 2019 Nov 23;20(1):559. doi: 10.1186/s12891-019-2935-z.'}]}, 'descriptionModule': {'briefSummary': 'Cesarean delivery (CD) is an obstetric surgery for fetal delivery that involves both an abdominal incision (laparotomy) and a uterine incision (hysterotomy). It is presently the most prevalent surgery in the United States, with over 1 million women giving birth by cesarean section each year.', 'detailedDescription': 'The anaesthetic types of choice for cesarean delivery are neuraxial and general anaesthesia.\n\nNeuraxial anesthesia is the gold standard anaesthesia for CD; it includes spinal and epidural anaesthesia. For spinal anaesthesia, local anesthetics are injected into the spinal canal, while for epidural anaesthesia, they are injected into the epidural space.\n\nDespite the superiority of neuraxial anaesthesia for cesarean delivery, general anesthesia is still performed to some extent especially when neuraxial anaesthesia is failed or inconsistent.\n\nGeneral anesthesia involves a transient state of unconsciousness through the administration of inhaled anesthetic gases combined with intravenous drugs.\n\nLBP patients showed changes in their neuromuscular activity, reduction in the lumbar muscle flexibility, and alteration of the biomechanical properties of the lumbar muscles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sixty-three women participated in this study and were recruited from South Valley University Teaching Hospitals, in Qena governorate, Egypt.', 'genderDescription': "Because this study is presented to the department of Physical Therapy for Women's Health to observe the changes after cesarean delivery and its relevant anaesthesia.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All women gave birth through a cesarean delivery.\n2. All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.\n3. Their ages ranged from 18 to 35 years.\n4. All participants had a body mass index (BMI) of not more than 30, and a waist-to-hip ratio of not more than 1.\n5. Participants were assessed between the 6th week to the 12th week postnatal.\n6. All participants were able to continue all assessment procedures.\n7. They were medically stable.\n\nExclusion Criteria:\n\n1. Women who delivered through vaginal delivery.\n2. Women who delivered through cesarean delivery, but the used anaesthetic technique was the paramedian approach for either the epidural or spinal anaesthesia.\n3. Women with urinary tract infections.\n4. Women who were below 18 years old or above 35 years old.\n5. Women who had a (BMI) above 30 or a waist-to-hip ratio above 1.\n6. Women who did not continue all assessment procedures.\n7. Women who had any specific low back pain as women who were diagnosed with lumbar disc prolapse, scoliosis, or spondylolisthesis.'}, 'identificationModule': {'nctId': 'NCT05503758', 'briefTitle': 'Biomechanical Properties of the Lumbar Paravertebral Muscles', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Quantification of Different Lumbar Paravertebral Muscles Properties in Women Who Experienced Cesarean Delivery Under Different Types of Anaesthesia', 'orgStudyIdInfo': {'id': 'Lumbar Paravertebral muscles'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': '9 participants have exposed to midline epidural anaesthesia for cesarean delivery.', 'interventionNames': ['Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)']}, {'label': 'Group B', 'description': '22 participants have exposed to midline spinal anaesthesia for cesarean delivery.', 'interventionNames': ['Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)']}, {'label': 'Group C', 'description': '10 participants underwent general anesthesia for cesarean delivery.', 'interventionNames': ['Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)']}, {'label': 'Group D', 'description': '22 participants were in the control group (no previous pregnancy or anaesthesia).', 'interventionNames': ['Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)']}], 'interventions': [{'name': 'Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)', 'type': 'DEVICE', 'otherNames': ['Myotonometry'], 'description': 'The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Qina', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'Faculty of physical therapy, South Valley University', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Assistant Lecturer of Physical Therapy for Women's Health", 'investigatorFullName': 'Mohamed Gamal Abouelyazeed Ali', 'investigatorAffiliation': 'South Valley University'}}}}