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Not yet recruiting NCT07478718

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

No phase Interventional Women Following Unilateral Mastectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Women Following Unilateral Mastectomy. Basic parameters: 30 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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"

Overview

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

  • 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

Primary outcome measures

  • Shoulder Function [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Secondary out come [Time frame: 16weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Jordan · 1 center
  • Hany elgohary — Jerash

Publications

  • 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
  • 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

Identifiers

NCT: NCT07478718 · Badr University in Cairo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗