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临床试验/NCT07478718
NCT07478718尚未招募不适用

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

South Valley University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
33
试验地点
1
主要终点
Shoulder Function

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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 >
  • Ability to ambulate independently and follow therapist instructions.
  • Willingness to commit to the full rehabilitation protocol for 8 weeks.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: 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)

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.

干预措施: 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)

结局指标

主要结局

Shoulder Function

时间窗: 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

次要结局

  • Secondary out come(16weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Abuzaid

Head Department of physical therapy for cardiovascular/ Respiratory disorders and geriatrics

South Valley University

研究点 (1)

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