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NCT Number: NCT07676045

Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy

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.

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Key information

Conditions

Breast Cancer Related Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Femwell Physiotherapy Clinic

Lahore, Punjab Province, Pakistan

About this study

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).

The entire intervention protocol will be conducted 3 times a week for a duration of 4 weeks. Standardized outcome evaluations will monitor changes in limb circumference discrepancy via tape measurements, upper limb functional mobility using a universal goniometer, disability levels using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and subjective pain levels on the Numeric Pain Rating Scale (NPRS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Manual Lymphatic Drainage

Behavioral

A specialized manual therapy technique involving gentle, slow, rhythmic skin-stretching strokes directed toward functioning, unaffected proximal lymph nodes to stimulate lymphatic flow and reduce upper extremity swelling. Administered for 25 to 30 minutes per session, 3 times a week for 4 weeks.

Diaphragmatic Breathing Exercises

Behavioral

Structured deep breathing exercises performed in a comfortable, semi-reclined position. Participants practice controlled inhalation through the nose for 4 seconds (allowing the abdomen to expand) followed by a controlled exhalation phase and a 4-second pause before the next breath cycle. Administered for 2 minutes immediately following Manual Lymphatic Drainage, 3 times a week for a total duration of 4 weeks.

Primary outcomes

  1. Limb Circumference

    Time frame: 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.

  2. Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

    Time frame: 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).

  3. Numeric Pain Rating Scale (NPRS)

    Time frame: 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.

  4. Shoulder Joint Range of Motion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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