Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:20 PM
Study NCT ID:
NCT07478718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009934', 'term': 'Organization and Administration'}], 'ancestors': [{'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A randomized clinical trial was conducted involving 66 women who underwent unilateral mastectomy. Participants were randomly assigned to either a Scapular-Shoulder Exercise Group (SSEG; n = 33) or a Control Group receiving conventional physiotherapy (CG; n = 33). The intervention lasted 8 weeks and consisted of scapular stabilization, mobility, neuromuscular control, and shoulder strengthening exercises. Outcomes were measured at baseline, post-treatment, and 8 week follow-up, including pain intensity (VAS), upper-limb function (DASH), shoulder range of motion, kinesiophobia (TSK-11), self-efficacy, psychological well-being, and incidence of secondary shoulder-hand syndrome. Data were analyzed using mixed-model ANOVA with Bonferroni post-hoc tests, chi-square analysis, and partial eta squared (ηp²) for effect sizes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized clinical trial was conducted involving 66 women who underwent unilateral mastectomy. Participants were randomly assigned to either a Scapular-Shoulder Exercise Group (SSEG; n = 33) or a Control Group receiving conventional physiotherapy (CG; n = 33). The intervention lasted 8 weeks and consisted of scapular stabilization, mobility, neuromuscular control, and shoulder strengthening exercises. Outcomes were measured at baseline, post-treatment, and 8 week follow-up, including pain intensity (VAS), upper-limb function (DASH), shoulder range of motion, kinesiophobia (TSK-11), self-efficacy, psychological well-being, and incidence of secondary shoulder-hand syndrome. Data were analyzed using mixed-model ANOVA with Bonferroni post-hoc tests, chi-square analysis, and partial eta squared (ηp²) for effect sizes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Function', 'timeFrame': '8 weeks', 'description': 'Shoulder Function\n\n1. DASH (Disabilities of the Arm, Shoulder and Hand)\n\n * Reliable in post-mastectomy populations.\n * Range: 0 (best) to 100 (worst).\n2. Shoulder Range of Motion (ROM)\n\n * Measured using a calibrated universal goniometer\n * Movements: flexion, abduction, external and internal rotation\n * Three trials averaged for analysis'}], 'secondaryOutcomes': [{'measure': 'Secondary out come', 'timeFrame': '16weeks', 'description': 'Pain Intensity\n\n• Visual Analog Scale (VAS, 0-10) at rest and during movement 2. Incidence of Secondary Shoulder-Hand Syndrome (SHS)\n\nDiagnosis based on recognized clinical criteria:\n\n* Continuous upper limb pain\n* Diffuse edema of hand/fingers\n* Stiffness of wrist/hand joints\n* Trophic skin changes (temperature, sweating, glossy skin)\n* Reduced grip strength\n* Symptoms persisting \\> 2 weeks Diagnosis will be made by an oncologic rehabilitation specialist. 3. Muscle Strength\n* Shoulder flexors, abductors, and external rotators\n* Measured using portable hand-held dynamometry (HHD)\n* Three trials with 1-minute rest 4. Quality of Life\n* EORTC QLQ-BR23 (breast cancer-specific module) 5. Shoulder Mobility Patterns\n* Observed scapulohumeral rhythm\n* Documented using a standardized clinical checklist'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Shoulder rehabilitation', 'Scapular exercises', 'Women Following Unilateral Mastectomy'], 'conditions': ['Women Following Unilateral Mastectomy']}, 'referencesModule': {'references': [{'pmid': '36922413', 'type': 'RESULT', 'citation': 'Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.'}, {'pmid': '36814100', 'type': 'RESULT', 'citation': 'Pirincci CS, Dalyan M, Delialioglu SU, Celenay ST. Effects of scapulothoracic stabilization exercises on scapular function, posture, and balance in lymphedema after mastectomy: a randomized controlled trial. Women Health. 2023 Apr;63(4):251-265. doi: 10.1080/03630242.2023.2178836. Epub 2023 Feb 22.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36922413/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome', 'detailedDescription': 'Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome. Conventional physiotherapy provides general postoperative rehabilitation but may not adequately address altered scapulothoracic mechanics or psychological factors that contribute to persistent dysfunction. Targeted scapular and shoulder exercises may enhance clinical recovery; however, high-quality evidence supporting their effectiveness remains limited'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'Women Following Unilateral Mastectomy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n 1. Female adults between 30 and 65 years old.\n 2. History of unilateral breast cancer managed with either:\n\n * Modified radical mastectomy, or\n * Breast-conserving surgery with axillary clearance.\n 3. Postoperative interval between 4 and 12 weeks before enrollment.\n 4. Objective evidence of impaired shoulder mobility or function including:\n\n * Reduction of ROM ≥ 15% compared to the contralateral side,\n * VAS pain ≥ 3/10 during shoulder movement, or\n * DASH functional score \\> 25.\n 5. Ability to ambulate independently and follow therapist instructions.\n 6. Willingness to commit to the full rehabilitation protocol for 8 weeks.\n\nExclusion Criteria:\n\n* Participants will be excluded if they have:\n\n * Previously diagnosed shoulder disorders (adhesive capsulitis, rotator cuff tear, fracture/dislocation).\n * Active or untreated lymphedema Grade II-III.\n * Ongoing chemotherapy-induced neuropathy causing shoulder dysfunction.\n * History of neurological or rheumatological disorders affecting the upper limb.\n * Metastatic disease or local recurrence.\n * Recent infection, seroma, or unhealed surgical wounds.\n * Participation in another physical therapy or exercise program in the past 4 weeks.\n * Cognitive impairment or psychiatric conditions interfering with adherence.'}, 'identificationModule': {'nctId': 'NCT07478718', 'briefTitle': 'Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Effect of Targeted Scapular and Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy "Randomized Controlled Trial"', 'orgStudyIdInfo': {'id': 'Badr University in Cairo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scapular-Shoulder Exercise Group', 'description': 'Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration\n\n* 3 sessions/week\n* 45-60 minutes per session\n* Total duration: 8 weeks (24 sessions)\n* Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience\n\nAll participants will receive the standard physiotherapy protocol implemented at the center, including:\n\n* Posture correction education\n* Diaphragmatic breathing\n* Scar mobilization\n* Gentle ROM exercises\n* Pain education\n* Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises.', 'interventionNames': ['Procedure: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'All participants will receive the standard physiotherapy protocol implemented at the center, including:\n\n* Posture correction education\n* Diaphragmatic breathing\n* Scar mobilization\n* Gentle ROM exercises\n* Pain education\n* Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises.', 'interventionNames': ['Procedure: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted']}], 'interventions': [{'name': 'Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted', 'type': 'PROCEDURE', 'description': 'Interventions\n\n1\\. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration\n\n* 3 sessions/week\n* 45-60 minutes per session\n* Total duration: 8 weeks (24 sessions)\n* Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience (10).\n\nExercise Components\n\nThe program consists of five progressive phases:\n\nPhase 1: Mobility and Motor Control (Week 1-2)\n\n* Pendulum exercises\n* Active-assisted ROM using pulleys or wand\n* Scapular clocks and gentle setting exercises\n* Pectoralis minor and posterior capsule stretching\n* Deep breathing and thoracic mobilization exercises Phase 2: Early Scapular Activation (Week 2-3)\n* Scapular retraction with tactile cueing\n* Serratus anterior low-load activation (wall slides, punches without resistance)\n* Lower trapezius recruitment in prone position\n* Active ROM to 120° flexion/abduction Phase 3: Functional Strengthening (Week 3-5)\n* Resistance-band exercises (yellow to red):\n\n * External rotation\n * Flex', 'armGroupLabels': ['Control Group', 'Scapular-Shoulder Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22B', 'city': 'Jerash', 'country': 'Jordan', 'contacts': [{'name': 'Hany Elgohary, Associate professor', 'role': 'CONTACT', 'email': 'hmielgohary@gmail.com', 'phone': '+962797756592'}], 'facility': 'Hany elgohary', 'geoPoint': {'lat': 32.28082, 'lon': 35.89929}}], 'centralContacts': [{'name': 'ibrahim ismail Abuzaid, Assistant professor', 'role': 'CONTACT', 'email': 'ibrahim_ismail_2011@svu.edu.eg', 'phone': '797756592'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Department of physical therapy for cardiovascular/ Respiratory disorders and geriatrics', 'investigatorFullName': 'Ibrahim Abuzaid', 'investigatorAffiliation': 'South Valley University'}}}}