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

NCT07478718 | Not Yet Recruiting DMC

• 1 other identifier: Badr University in Cairo
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Women Following Unilateral Mastectomy

Keywords

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

Outcome Measures

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

  8 weeks

Secondary Outcomes (1)

• Secondary out come

  16weeks

Study Arms (2)

Scapular-Shoulder Exercise Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

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 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

Control Group; Scapular-Shoulder Exercise Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Women Following Unilateral Mastectomy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Hany elgohary

Jerash, 22B, Jordan

Location

Related Publications (2)

• 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: 36922413 RESULT

• 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.

  PMID: 36814100 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Services Administration

Central Study Contacts

ibrahim ismail Abuzaid, Assistant professor

CONTACT

797756592; ibrahim_ismail_2011@svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Department of physical therapy for cardiovascular/ Respiratory disorders and geriatrics

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

JO (1)