Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 8:13 PM
Study NCT ID:
NCT07037056
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Posture CS and STM on Reducing Shoulder and Neck Pain in Breastfeeding Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': '6 Month', 'description': 'The Numeric Pain Rating Scale (NPRS) is an 11-point scale used to measure pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).'}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': '6 Months', 'description': "The Neck Disability Index (NDI) is a questionnaire used to assess how neck pain affects a person's daily life and disability. It consists of 10 items, each scored on a 0-5 scale, resulting in a total score ranging from 0 to 50. A higher score indicates greater perceived disability due to neck pain"}, {'measure': 'Breastfeeding self efficacy scale', 'timeFrame': '6 months', 'description': "All items are preceded by the phrase ''I can always'' and rated on a 5-point Likert scale, ranging from 1 (not at all confident) to 5 (always confident). Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'Breastfeeding, though essential for the nourishment and development of newborns, often imposes significant musculoskeletal strain on mothers, particularly in the neck and shoulder regions. Prolonged static postures, repetitive feeding routines, and improper ergonomic positions contribute to mechanical stress, leading to chronic discomfort or pain during the postpartum period Postnatal women frequently assume awkward positions while nursing, such as forward head posture, rounded shoulders, and spinal flexion, which contribute to musculoskeletal dysfunctions . The cumulative load on the musculoskeletal and fascial systems during breastfeeding leads to muscle imbalances, myofascial tightness, and trigger point development.', 'detailedDescription': 'Current physiotherapy interventions emphasize posture education, ergonomic training, and targeted exercises to mitigate this pain. Posture correction exercises aim to improve alignment, decrease strain on muscles and joints, and enhance motor control in the upper quarter . Soft tissue moblization a manual therapy technique targeting fascial layers, has also shown promising results in improving mobility, reducing trigger point activity, and decreasing referred pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum period of up to 12 months\n\nExclusion Criteria:\n\n* History of trauma or cervical disc pathology\n* Neurological disorders\n* Previous musculoskeletal surgeries'}, 'identificationModule': {'nctId': 'NCT07037056', 'briefTitle': 'The Effects of Posture CS and STM on Reducing Shoulder and Neck Pain in Breastfeeding Mothers', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'The Effects of Posture Correction Exercises and Soft Tissue Mobilization on Reducing Shoulder and Neck Pain in Breastfeeding Mothers', 'orgStudyIdInfo': {'id': 'DPT/Batch-Fall20/1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shoulder and Neck Strengthening + Postural Correction Exercises', 'interventionNames': ['Combination Product: Shoulder and Neck Strengthening + Postural Correction Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shoulder and Neck Strengthening + soft tissue mobilization', 'interventionNames': ['Combination Product: Shoulder and Neck Strengthening + soft tissue mobilization']}], 'interventions': [{'name': 'Shoulder and Neck Strengthening + Postural Correction Exercises', 'type': 'COMBINATION_PRODUCT', 'description': 'Physiotherapy exercises of Shoulder and Neck Strengthening + Postural Correction Exercises for shoulder and neck pain', 'armGroupLabels': ['Shoulder and Neck Strengthening + Postural Correction Exercises']}, {'name': 'Shoulder and Neck Strengthening + soft tissue mobilization', 'type': 'COMBINATION_PRODUCT', 'description': 'Physiotherapy exercises of Shoulder and Neck Strengthening + soft tissue mobilization Exercises for shoulder and neck pain', 'armGroupLabels': ['Shoulder and Neck Strengthening + soft tissue mobilization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Lahore City', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}