Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT06303258
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D017699', 'term': 'Pelvic 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': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single (Outcomes Assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Changes from Baseline to 2nd week', 'description': 'It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients'}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Changes from 2nd week to 4th week', 'description': 'It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients'}, {'measure': "Pregnant women's quality of life questionnaire (QOL-GRAV)", 'timeFrame': 'Changes from Baseline to 2nd week', 'description': "Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all \\[0\\] to totally \\[4\\]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse."}, {'measure': "Pregnant women's quality of life questionnaire (QOL-GRAV)", 'timeFrame': 'Changes from 2nd week to 4th week', 'description': "Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all \\[0\\] to totally \\[4\\]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Pelvic Pain']}, 'referencesModule': {'references': [{'pmid': '28233012', 'type': 'BACKGROUND', 'citation': 'Sklempe Kokic I, Ivanisevic M, Uremovic M, Kokic T, Pisot R, Simunic B. Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial. J Rehabil Med. 2017 Mar 6;49(3):251-257. doi: 10.2340/16501977-2196.'}, {'pmid': '30471967', 'type': 'BACKGROUND', 'citation': 'Stuge B. Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review. Braz J Phys Ther. 2019 Mar-Apr;23(2):181-186. doi: 10.1016/j.bjpt.2018.11.006. Epub 2018 Nov 17.'}, {'pmid': '33230993', 'type': 'BACKGROUND', 'citation': 'Varela-Esquivias A, Diaz-Martinez L, Avendano-Badillo D. [Efficacy of lumbopelvic stabilization exercises in patients with lumbalgia]. Acta Ortop Mex. 2020 Jan-Feb;34(1):10-15. Spanish.'}, {'pmid': '26550815', 'type': 'BACKGROUND', 'citation': 'Leonard JH, Paungmali A, Sitilertpisan P, Pirunsan U, Uthaikhup S. Changes in Transversus Abdominis Muscle Thickness after Lumbo-Pelvic Core Stabilization Training among Chronic Low Back Pain Individuals. Clin Ter. 2015;166(5):e312-6. doi: 10.7417/T.2015.1884.'}]}, 'descriptionModule': {'briefSummary': 'Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.', 'detailedDescription': 'This is a randomized control trial to compare the effects of core stabilization versus generalized antenatal exercises for lumbopelvic pain in pregnant women. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated by core stability exercises and group B will be treated by generalized antenatal exercises and group C will receive basic antenatal education. Group A and B will have three treatment sessions per week for 4 weeks. Females will be evaluated at baseline and 2nd and 4th week . Females will be screened by Patricks faber test, piriformis /FAIR test, p4/posterior pelvic pain provocation test and assessed by visual analogue scale (VAS) and pregnant women quality of life questionnaire (QOL- GRAV).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2nd Trimester of Pregnancy\n* Multigravida\n* Patients having Lumbopelvic pain\n* Working women and housewives\n\nExclusion Criteria:\n\n* Hx of Metabolic Disease\n* Hx of Pelvic Fracture and Surgery\n* Radiculopathy\n* Participants with absolute contraindications for the exercise'}, 'identificationModule': {'nctId': 'NCT06303258', 'briefTitle': 'Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparison of Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain In Pregnancy', 'orgStudyIdInfo': {'id': 'RiphahIU Sharmeen Kanwar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Core Stabalization Exercises Group', 'description': 'This Group will receive core stability exercises 3 sessions per week for 4 weeks and basic antenatal education.', 'interventionNames': ['Other: Core Stabalization Exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Generalized Exercise Group', 'description': 'This Group will receive generalized supervised antenatal exercises that are covered in three phases and basic antenatal education. There will be 3 sessions per week for 10weeks conducted for generalized antenatal exercises including Aerobics, Endurance and Pelvic Floor Muscle Training.', 'interventionNames': ['Other: Generalized Antenatal Exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Basic Antenatal Education for Lumbopelvic Pain Prevention'}], 'interventions': [{'name': 'Core Stabalization Exercises', 'type': 'OTHER', 'description': 'Low Intensity Warm Up Exercises Core Stabilization Exercises Cool Down Stretching Exercises', 'armGroupLabels': ['Core Stabalization Exercises Group']}, {'name': 'Generalized Antenatal Exercises', 'type': 'OTHER', 'description': 'Low Intensity WarmUp Exercise Aerobic Training Endurance Training Pelvic Floor Muscle Training Cool Down Stretching Exercises', 'armGroupLabels': ['Generalized Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55150', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Tehsil Headquarter Hospital Raiwind', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Huma Riaz, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}