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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.
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:
Following the baseline session, the groups will receive their distinct experimental protocols:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Femwell Physiotherapy Clinic | Lahore | Punjab Province | Pakistan |
Individual participant data will not be shared outside of the primary research team to maintain patient confidentiality and privacy. The final study results will only be available as aggregated data through the final thesis publication.
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| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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| 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. |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |