Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 3:30 PM
Study NCT ID:
NCT06814704
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of lumbar lordotic angle', 'timeFrame': 'It will be done for each case at the end of the study up to 8 weeks', 'description': 'The angle will be measured using flexible ruler once before and once after the study by the primary examiner, who repeated each measurement three times.'}], 'primaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'Pain assessment at the end of the study up to 8 weeks', 'description': 'pain: The Revised Short McGill Pain Questionnaire will be used to assess both groups before and after the study.'}], 'secondaryOutcomes': [{'measure': 'Assessment of functional disability', 'timeFrame': 'This scale will be done for each case at the end of the study up to 8 weeks', 'description': 'The Patient-Specific Functional Scale (PSFS) will be used to assess functional changes in patients with musculoskeletal illnesses using self-reported data. Patients rated to five activities on an 11-point scale based on their current level of difficulty.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postpartum', 'low back pain', 'Quality of life'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.\n\nHypopressive exercises are safe and beneficial for new moms, as they can be started soon after delivery. They help strengthen postural muscles, reduce back pain, and manage pain by reducing intra-abdominal pressure, increasing activity of postural musculature, and normalizing myofascial tension.', 'detailedDescription': '38 postpartum women with abnormal hyperlordosis. The women were then divided into two equal groups. Group A(n=19) received hypopressive abdominal exercise along with traditional treatment for lower back pain (LBP), while Group B(n=19) received the same treatment without hypopressive exercise. The main outcomes measured were the the Revised Short McGill Pain Questionnaire Version-2, the lumbar lordotic angle, and the patient-specific functional scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- participants must have a healthy pregnancy, a typical vaginal birth, LBP that existed 24 weeks after giving birth, and functional limitations in daily activities. The study only allowed women aged 20-35 with no more than two prior pregnancies and a BMI of less than 25 kg/m2 to participate.\n\nExclusion Criteria:\n\n* women who under pharmacological or psychological treatment, had pelvic tumors, lumbar disk herniation, heart disease, hypertension, lumbar spine tumors, chronic uterine prolapse, chronic pelvic pain, lumbar spondylosis, or lumbar spondylolisthesis.'}, 'identificationModule': {'nctId': 'NCT06814704', 'acronym': 'LBP', 'briefTitle': 'Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability', 'orgStudyIdInfo': {'id': 'Hypopressive Exercises'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': 'Group A will receive 1. hypopressive abdominal exercises 2. traditional treatment for low back pain (Pharmacological treatment (paracetamol 0.5-1g 3times/day),Heat therapy Continuous low-level heat wrap(electrical) 3. Progressive strength training.', 'interventionNames': ['Other: Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group (B)', 'description': 'Group B will receive 1. traditional treatment for low back pain (Pharmacological treatment (paracetamol 0.5-1g 3times/day),Heat therapy Continuous low-level heat wrap(electrical) 2. Progressive strength training.', 'interventionNames': ['Other: heat therapy, pharmacological therapy, progressive strengthening exercises']}], 'interventions': [{'name': 'Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises', 'type': 'OTHER', 'description': '20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training).', 'armGroupLabels': ['Group (A)']}, {'name': 'heat therapy, pharmacological therapy, progressive strengthening exercises', 'type': 'OTHER', 'description': 'Hypopressive exercises :The women were instructed to hold breath with chest extension for approximately 10 seconds before they began to breathe again. Then, using a series of upper and lower limb positions, the subjects were shown how to apply a series of "hypopressive postures', 'armGroupLabels': ['Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Kafrelsheikh university', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'it need to have a permission from the faculty and university first'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Salwa A. Shawat', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}