Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
Study NCT ID:
NCT06713759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-11-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Postural Balance Changes on Low Back Pain During Pregnancy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-11-28', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'balance', 'timeFrame': 'up to thirty four weeks', 'description': 'The Biodex Balance System SD will be used to assess balance.higher values indicate more deviations and poor balance control.'}, {'measure': 'pressure pain threshold', 'timeFrame': 'up to thirty four weeks', 'description': 'digital pressure algometer from Wagner Instruments will be used to assess pressure pain threshol.The algometer was set to measure at a rate of 100 readings per second and always displayed the highest pressure measured. The round attachment surface had a diameter of 1.12 cm. Newton (N) was set as the unit of measurement on the device. Later, it was converted to kilopascals (kPa) to enable comparability with other studies'}], 'secondaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'up to thirty four weeks', 'description': 'visual analogue scale will be used to assess pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient\'s mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postural balance', 'low back pain', 'pregnacy'], 'conditions': ['Pregnancy', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'this study will be conducted to determine the impact of postural balance changes on low back pain during pregnancy', 'detailedDescription': 'Back pain is a major problem in the general population, and it is thought to be even more common in pregnant women who have given birth. It has been hypothesized that this type of pregnancy-related low back pain (LBP) may be related to changes in lumbar posture, perhaps accompanied by stretching abdominal muscles or specific hormonal effects of pregnancy .During pregnancy, many hormonal, anatomical, and musculoskeletal changes occur. These changes alter the postural balance and increase the risk of falls. Falls during pregnancy can cause maternal and foetal injuries. Moreover, the incidence of falls during pregnancy is higher compared to non-pregnant women of the same age. The risk of falls increases with the gestational age, and most falls are experienced in the third trimester. so, this study will be designed to conduct new information about the relation between postural changes and low back pain during pregnancy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be conducted on forty pregnant women (in second and third trimesters) suffering from low back pain', 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women in 2nd and 3rd trimesters.\n* Pregnant women suffering from low back pain\n* Their Age will range from 20-35 years.\n* Their Body mass index (BMI) will be less than 35 kg/m2\n\nExclusion Criteria:\n\n* Non pregnant women.\n* Women who have any history of diseases associated with balance disorder\n* Women who have any Neurological disorders.\n* Women who have Lower limbs deformities\n* Women who have Optical problems and disorders\n* Women who have Cerebrovascular disease'}, 'identificationModule': {'nctId': 'NCT06713759', 'acronym': 'LBP', 'briefTitle': 'Impact of Postural Balance Changes on Low Back Pain During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Impact of Postural Balance Changes on Low Back Pain During Pregnancy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005384'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'primigravida women', 'description': 'This group will include 20 primigravida pregnant woman with low back pain. They will undergo balance and low back pain assessment (at 2 different time points: one at their second trimester (22-24) weeks and the other one in their third trimester (34th) week'}, {'label': 'Multigravida women', 'description': 'This group will include 20 pregnant women with low back pain. They will undergo balance and low back pain assessment (at 2 different time points: one at their second trimester (22-24) weeks and the other one in their third trimester (34th) week'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'nada Ali, master', 'role': 'CONTACT', 'email': 'nodadoda24@gmail.com', 'phone': '01140767665'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator: nada fawzy ali', 'investigatorFullName': 'Nada Fawzy Ali', 'investigatorAffiliation': 'October 6 University'}}}}