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

March 17, 2026 updated by: Ibrahim Abuzaid, South Valley University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Jerash, Jordan, 22B
        • Hany elgohary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scapular-Shoulder Exercise Group

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

All participants will receive the standard physiotherapy protocol implemented at the center, including:

  • Posture correction education
  • Diaphragmatic breathing
  • Scar mobilization
  • Gentle ROM exercises
  • Pain education
  • Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises.
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

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
Active Comparator: Control Group

All participants will receive the standard physiotherapy protocol implemented at the center, including:

  • Posture correction education
  • Diaphragmatic breathing
  • Scar mobilization
  • Gentle ROM exercises
  • Pain education
  • Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises.
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Function
Time Frame: 8 weeks

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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Badr University in Cairo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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