Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Limb Circumference
研究概览
简要总结
Lymphedema is a persistent and chronic swelling condition that commonly develops after breast cancer surgeries involving axillary lymph node dissection (ALND). This condition causes pain, heaviness, and swelling in the upper limb, which severely limits shoulder mobility and functional performance in daily life tasks.
While manual lymphatic drainage (MLD) is widely utilized to stimulate lymphatic flow and reduce tissue swelling, the added therapeutic benefit of combining it with deep breathing exercises remains less evaluated. This study is a randomized controlled trial designed to investigate whether combining diaphragmatic breathing exercises with manual lymphatic drainage is more effective than manual lymphatic drainage alone.
The main goals of this study are to determine if this combined intervention provides greater reductions in arm circumference and subjective pain levels while significantly improving upper extremity range of motion and overall functional ability in female patients recovering from a radical mastectomy.
详细描述
Participants who meet the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and affiliated clinical settings. Following informed consent, participants will be randomly assigned to one of two parallel groups using the lottery method to ensure unbiased allocation. The total study duration will span 4 weeks, with clinical outcomes measured at baseline and at the conclusion of the 4th week.
Both groups will first receive a standardized baseline physical therapy program consisting of:
- Transcutaneous Electrical Nerve Stimulation (TENS) applied for 10 minutes.
- Active range of motion (AROM) exercises for the shoulder, elbow, and wrist (10 repetitions each).
- Gentle upper limb muscle stretching (3-5 repetitions with a 10-second hold).
Following the baseline session, the groups will receive their distinct experimental protocols:
- Group A (Control Group): Will receive 25 to 30 minutes of specialized Manual Lymphatic Drainage (MLD). This manual therapy will employ gentle, slow, and rhythmic skin-stretching strokes directed toward functioning, proximal, unaffected lymph nodes to enhance fluid clearance.
- Group B (Experimental Group): Will receive the identical 25 to 30 minutes of MLD, followed immediately by 2 minutes of structured diaphragmatic breathing exercises. Participants will practice controlled deep breathing in a comfortable, semi-reclined position (inhaling through the nose for 4 seconds, allowing the abdomen to rise, followed by exhalation and a 4-second pause before the next breath).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 65 years.
- •Patients diagnosed with unilateral upper limb lymphedema secondary to radical mastectomy.
- •Patients with stage I or stage II lymphedema.
- •Patients who provide written informed consent to participate in the study
排除标准
- •Patients with bilateral upper limb lymphedema.
- •Presence of active, recurrent, or metastatic cancer.
- •Acute skin infections or cellulitis in the affected upper extremity.
- •Severe cardiac conditions, congestive heart failure, or unstable deep vein thrombosis (DVT).
- •Patients who have undergone specialized physical therapy or manual lymphatic drainage for lymphedema within the past 3 months.
结局指标
主要结局
Limb Circumference
时间窗: Baseline and post-intervention at 4 weeks
Upper limb edema volume will be assessed quantitatively using a sequential tape measurement protocol. Linear measurements of arm circumference will be recorded in centimeters at multiple standardized anatomical landmarks across both the affected and unaffected upper extremities to calculate overall swelling discrepancy.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
时间窗: Baseline and post-intervention at 4 weeks
A 30-item self-report questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. It assesses the patient's capability to perform specific functional activities, symptom severity (such as pain, tingling, and stiffness), and the social/psychological impact on daily life. Score ranges from 0 (no disability) to 100 (severe disability).
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline and post-intervention at 4 weeks
A subjective 11-point pain scale where patients rate their current upper extremity pain intensity on a scale from 0 to 10. A score of 0 represents 'no pain' and a score of 10 represents the 'worst possible pain.
Shoulder Joint Range of Motion
时间窗: Baseline and post-intervention at 4 weeks
Active range of motion for shoulder flexion, extension, abduction, and internal/external rotation will be measured quantitatively in degrees using a standard universal goniometer to assess upper extremity functional mobility.
次要结局
未报告次要终点