Skip to content

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

Effect of Targeted Scapular and Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy "Randomized Controlled Trial"

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07478718
Enrollment
33
Registered
2026-03-17
Start date
2026-04-01
Completion date
2026-08-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women Following Unilateral Mastectomy

Keywords

Breast cancer, Shoulder rehabilitation, Scapular exercises, Women Following Unilateral Mastectomy

Brief summary

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

Detailed description

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

Interventions

PROCEDUREInterventions 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 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

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants must meet all of the following criteria: 1. Female adults between 30 and 65 years old. 2. History of unilateral breast cancer managed with either: * Modified radical mastectomy, or * Breast-conserving surgery with axillary clearance. 3. Postoperative interval between 4 and 12 weeks before enrollment. 4. Objective evidence of impaired shoulder mobility or function including: * Reduction of ROM ≥ 15% compared to the contralateral side, * VAS pain ≥ 3/10 during shoulder movement, or * DASH functional score \> 25. 5. Ability to ambulate independently and follow therapist instructions. 6. Willingness to commit to the full rehabilitation protocol for 8 weeks.

Exclusion criteria

* Participants will be excluded if they have: * 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. * Metastatic disease or local recurrence. * Recent infection, seroma, or unhealed surgical wounds. * Participation in another physical therapy or exercise program in the past 4 weeks. * Cognitive impairment or psychiatric conditions interfering with adherence.

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Function8 weeksShoulder 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

Secondary

MeasureTime frameDescription
Secondary out come16weeksPain 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

Countries

Jordan

Contacts

CONTACTibrahim ismail Abuzaid, Assistant professor
ibrahim_ismail_2011@svu.edu.eg797756592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026