Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy

NCT07676045 | Active Not Recruiting

• 1 other identifier: 70094222
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Related Lymphedema

Keywords

lymphedema; post-mastectomy; manual lymphatic drainage; diaphragmatic breathing

Outcome Measures

Primary Outcomes (4)

• Limb Circumference

  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.

  Baseline and post-intervention at 4 weeks

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

  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).

  Baseline and post-intervention at 4 weeks

• Numeric Pain Rating Scale (NPRS)

  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.

  Baseline and post-intervention at 4 weeks

• Shoulder Joint Range of Motion

  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.

  Baseline and post-intervention at 4 weeks

Study Arms (2)

Group A: Control Group

ACTIVE COMPARATOR

This group will receive standard physical therapy management consisting of Transcutaneous Electrical Nerve Stimulation (TENS) for 10 minutes, active range of motion exercises for the upper limb, and gentle muscle stretching, followed by 25 to 30 minutes of specialized Manual Lymphatic Drainage (MLD). Treatment will be administered 3 times a week for a duration of 4 weeks.

Behavioral: Manual Lymphatic Drainage

Group B: Experimental Group

EXPERIMENTAL

This group will receive standard baseline physical therapy management consisting of Transcutaneous Electrical Nerve Stimulation (TENS) for 10 minutes, active range of motion exercises for the upper limb, and gentle muscle stretching, followed by 25 to 30 minutes of specialized Manual Lymphatic Drainage (MLD). Immediately following the manual therapy, participants will perform 2 minutes of structured diaphragmatic breathing exercises (controlled deep breathing in a semi-reclined position with a 4-second inhalation, abdominal expansion, and a 4-second exhalation phase). The complete protocol will be administered 3 times a week for a total duration of 4 weeks.

Behavioral: Manual Lymphatic Drainage; Behavioral: Diaphragmatic Breathing Exercises

Interventions

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.

Group A: Control Group; Group B: Experimental Group

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.

Group B: Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female participants are eligible for enrollment because this clinical trial evaluates specialized physical therapy protocols for upper limb lymphedema secondary to a radical mastectomy, a surgical procedure performed for breast cancer management in this specific population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Femwell Physiotherapy Clinic

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)