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Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy

23. Juni 2026 aktualisiert von: University of Lahore

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

58

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Femwell Physiotherapy Clinic

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Group A: Control Group
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.
Verhalten: Manual Lymphatic Drainage
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.
Experimental: Group B: Experimental Group
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.
Verhalten: Manual Lymphatic Drainage
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.
Verhalten: Diaphragmatic Breathing Exercises
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Limb Circumference
Zeitfenster: 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.
Baseline and post-intervention at 4 weeks
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Zeitfenster: 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).
Baseline and post-intervention at 4 weeks
Numeric Pain Rating Scale (NPRS)
Zeitfenster: 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.
Baseline and post-intervention at 4 weeks
Shoulder Joint Range of Motion
Zeitfenster: 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.
Baseline and post-intervention at 4 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Lahore

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. April 2026

Primärer Abschluss (Geschätzt)

10. Oktober 2026

Studienabschluss (Geschätzt)

10. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 70094222

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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