Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorSouth Valley University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female adults between 30 and 65 years old.

Modified radical mastectomy, or

Breast-conserving surgery with axillary clearance.

Postoperative interval between 4 and 12 weeks before enrollment.

Disqualifiers

Previously diagnosed shoulder disorders (adhesive capsulitis, rotator cuff tear, fracture/dislocation).

Active or untreated lymphedema Grade II-III.

Ongoing chemotherapy-induced neuropathy causing shoulder dysfunction.

History of neurological or rheumatological disorders affecting the upper limb.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Procedure/Surgery

    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 by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience (10). Exercise Components The program consists of five progressive phases: Phase 1: Mobility and Motor Control (Week 1-2) * Pendulum exercises * Active-assisted ROM using pulleys or wand * Scapular clocks and gentle setting exercises * Pectoralis minor and posterior capsule stretching * Deep breathing and thoracic mobilization exercises Phase 2: Early Scapular Activation (Week 2-3) * Scapular retraction with tactile cueing * Serratus anterior low-load activation (wall slides, punches without resistance) * Lower trapezius recruitment in prone position * Active ROM to 120° flexion/abduction Phase 3: Functional Strengthening (Week 3-5) * Resistance-band exercises (yellow to red): * External rotation * Flex

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: Scapular-Shoulder Exercise GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Shoulder Function

Shoulder Function 1. DASH (Disabilities of the Arm, Shoulder and Hand) * Reliable in post-mastectomy populations. * Range: 0 (best) to 100 (worst). 2. Shoulder Range of Motion (ROM) * Measured using a calibrated universal goniometer * Movements: flexion, abduction, external and internal rotation * Three trials averaged for analysis

Time frame
8 weeks

Secondary outcomes

1

Secondary out come

Pain Intensity • Visual Analog Scale (VAS, 0-10) at rest and during movement 2. Incidence of Secondary Shoulder-Hand Syndrome (SHS) Diagnosis based on recognized clinical criteria: * Continuous upper limb pain * Diffuse edema of hand/fingers * Stiffness of wrist/hand joints * Trophic skin changes (temperature, sweating, glossy skin) * Reduced grip strength * Symptoms persisting \> 2 weeks Diagnosis will be made by an oncologic rehabilitation specialist. 3. Muscle Strength * Shoulder flexors, abductors, and external rotators * Measured using portable hand-held dynamometry (HHD) * Three trials with 1-minute rest 4. Quality of Life * EORTC QLQ-BR23 (breast cancer-specific module) 5. Shoulder Mobility Patterns * Observed scapulohumeral rhythm * Documented using a standardized clinical checklist

Time frame
16weeks

Other outcomes

Sponsors and contacts

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