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NCT Number: NCT07478718

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

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

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must meet all of the following criteria:
  • Female adults between 30 and 65 years old.
  • History of unilateral breast cancer managed with either:
  • Modified radical mastectomy, or
  • Breast-conserving surgery with axillary clearance.
  • Postoperative interval between 4 and 12 weeks before enrollment.
  • 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.
  • Ability to ambulate independently and follow therapist instructions.
  • 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.

Treatment and study plan

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

Interventions

  • 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

Primary outcomes

  1. Shoulder Function

    Time frame: 8 weeks

    Shoulder Function

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

Secondary outcomes

  1. Secondary out come

    Time frame: 16weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

ibrahim ismail Abuzaid, Assistant professor

CONTACT

[email protected]

797756592

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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