Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-01 @ 11:26 PM
Study NCT ID:
NCT06817135
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Scapular Stabilization Exercise on Breastfeeding Women with Non-specific Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The control group got the standard physical therapy program, muscle energy technique for the sternocleidomastoid, elevator scapulae, upper trapezius, and pectoralis major, and advice, while the experimental group got the same conventional physical therapy program in addition to scapular stabilization exercises.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional neck disability', 'timeFrame': 'at beginning of the study and after four weeks of treatment', 'description': 'The Arabic version of the Neck Disability Index Questionnaire (NDI) is used to assess the functional neck disability. It consists of 10 items; each item scores from 0 to 5, where a score of 0 indicates no limitation and a score of 5 indicates maximum limitation.'}, {'measure': 'neck pain intensity', 'timeFrame': 'at beginning of the study and after four weeks of treatment', 'description': 'The Visual Analog Scale VAS was used to assess neck pain intensity for both groups at the beginning of the study and after four weeks of treatment. It is a 10 cm line. 0 means no paint and 10 means maximum pain and the patient chooses a point on the line which reflects the pain'}], 'secondaryOutcomes': [{'measure': 'pressure pain threshold', 'timeFrame': 'at beginning of the study and after four weeks of treatment', 'description': 'The local pressure pain threshold over the upper trapezius was measured using a pressure algometer. It is a portable digital algometer that responds linearly to force applications between 0 and 1300 kPa, or roughly 0 and 14 kg. With a 1-cm² circular rubber tip, the device measures the maximum force applied before the subject verbally indicates that the pain threshold has been reached.'}, {'measure': 'cervical range of motion', 'timeFrame': 'at beginning of the study and after four weeks of treatment', 'description': 'The cervical range of motion (flexion, extension, lateral flexion (Rt \\& Lt), and rotation (Rt \\& Lt)) is measured with a universal goniometer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['scapular stabilization exercise', 'Breast feeding women'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '35673945', 'type': 'BACKGROUND', 'citation': 'Abd El-Azeim AS, Mahmoud AG, Mohamed MT, El-Khateeb YS. Impact of adding scapular stabilization to postural correctional exercises on symptomatic forward head posture: a randomized controlled trial. Eur J Phys Rehabil Med. 2022 Oct;58(5):757-766. doi: 10.23736/S1973-9087.22.07361-0. Epub 2022 Jun 8.'}, {'pmid': '34151819', 'type': 'BACKGROUND', 'citation': 'Nitayarak H, Charntaraviroj P. Effects of scapular stabilization exercises on posture and muscle imbalances in women with upper crossed syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(6):1031-1040. doi: 10.3233/BMR-200088.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1007/s00520-023-07641-6', 'label': 'Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether scapular stabilization exercises can help breastfeeding women with non-specific neck pain by reducing their neck pain, cervical range of motion, and neck disability index.', 'detailedDescription': 'The best infant feeding practice is breastfeeding, which has both immediate and long-term advantages for mothers, babies, the environment, the economy, and society as a whole. Mothers who are nursing frequently experience neck pain. Because the scapula and neck are closely related, scapular stabilization is becoming more and more popular for patients with neck pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'breastfeeding mothers', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. exclusive breastfeeding mothers with immediate to 6-month-old infants.\n2. The bilateral cradle position is employed by patients when nursing.\n3. Patients had mechanical neck pain.\n4. Patients with a body mass index below 30 kg/m²\n5. Patients have moderate pain intensity, ranging from 3 to 7 on the visual analogue scale\n6. The patients' scores on the Neck Disability Index ranged from 10 to 40 out of 50.\n\nExclusion criteria:\n\n1. Patients had preterm babies or low-birth-weight babies.\n2. pregnant patients\n3. Patients had postpartum complications.\n4. Patients had inflammation, infection, severe degeneration, congenital deformity, and trauma.\n5. Patients had sensory abnormalities or a positive motor reflex.\n6. Patients had cancer, metabolic, or systemic diseases."}, 'identificationModule': {'nctId': 'NCT06817135', 'briefTitle': 'Effect of Scapular Stabilization Exercise on Breastfeeding Women with Non-specific Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Scapular Stabilization Exercise on Breastfeeding Women with Non-specific Neck Pain', 'orgStudyIdInfo': {'id': 'scapular stabilization ex.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Got a standard physical therapy program, muscle energy technique for (sternocleidomastoid, elevator scapulae, upper trapezius and pectoralis major) and advice', 'interventionNames': ['Other: Muscle Energy Technique', 'Other: Advice about the right the breastfeeding ergonomic.']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'got the same conventional physical therapy program plus scapular stabilization exercises.', 'interventionNames': ['Other: scapular stabilization exercises', 'Other: Muscle Energy Technique', 'Other: Advice about the right the breastfeeding ergonomic.']}], 'interventions': [{'name': 'scapular stabilization exercises', 'type': 'OTHER', 'description': 'Cools exercise using the Thera-Band, including sidelying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation, and prone extension exercises to promote lower trapezius and middle trapezius activity with minimal activation of the upper trapezius part.', 'armGroupLabels': ['Experimental group']}, {'name': 'Muscle Energy Technique', 'type': 'OTHER', 'otherNames': ['Autogenic Inhibition', 'Post Isometric Relaxation'], 'description': 'Muscle Energy Technique for the 1.sternocleidomastoid 2. levator scapulae 3. upper trapezius 4. pectoralis major Through mild isometric contractions, it uses the intrinsic energy of a muscle to lengthen it and induce relaxation through autogenic inhibition.', 'armGroupLabels': ['Experimental group', 'control group']}, {'name': 'Advice about the right the breastfeeding ergonomic.', 'type': 'OTHER', 'description': "The patients sit with their backs supported with pillows. Don't lean over the infant. Keep the arms supported and feet on the ground.", 'armGroupLabels': ['Experimental group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Saadyya A. Aladawi, Asst Lect', 'role': 'CONTACT', 'email': 'dr.saadyya@gmail.com', 'phone': '0020116364807'}], 'facility': 'Faculty of Physical Therapy/ Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Saadyya A. Abdalhamed Aladawi, Asst Lect', 'role': 'CONTACT', 'email': 'dr.saadyya@gmail.com', 'phone': '00201116364807'}, {'name': 'Dr.Afaf M. Mahmoud Botla, Asst. Prof', 'role': 'CONTACT', 'email': 'drafafmohamed@yahoo.com', 'phone': 'Assistant Professor'}], 'overallOfficials': [{'name': 'Prof. Dr. Amel M. Yousef, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saadyya Ahmed Abdalhamed Aladawi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "ِِِAssistant Lecturer in the of Women's Health Department", 'investigatorFullName': 'Saadyya Ahmed Abdalhamed Aladawi', 'investigatorAffiliation': 'Cairo University'}}}}