| Registry | NCT07676045 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 58 (Estimated) |
| Sponsor | University of Lahore (Other) |
| Conditions | Breast Cancer Related Lymphedema |
| Interventions | Manual Lymphatic Drainage, Diaphragmatic Breathing Exercises (Behavioral) |
| Dates | start 2026-04-10, primary completion 2026-10-10 (estimated), completion 2026-10-10 (estimated), first posted 2026-06-30, last updated 2026-06-30 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer Related Lymphedema All trials of Manual Lymphatic Drainage All trials of Diaphragmatic Breathing Exercises
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:
1. Transcutaneous Electrical Nerve Stimulation (TENS) applied for 10 minutes.
2. Active range of motion (AROM) exercises for the shoulder, elbow, and wrist (10 repetitions each).
3. 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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A: Control Group | Active comparator | Behavioral: Manual Lymphatic Drainage | 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. |
| Group B: Experimental Group | Experimental | Behavioral: Manual Lymphatic Drainage; Behavioral: Diaphragmatic Breathing Exercises | 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. |
Sex: Female, ages: 18 Years to 65 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Femwell Physiotherapy Clinic | Lahore, Punjab Province | Pakistan |