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NCT Number: NCT07576270

Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy

This study aims to determine the combined effect of resisted deep breathing and Myofascial release on pain, respiratory efficiency, chest mobility and lymph edema in Postmastectomy.

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Key information

Conditions

Post Mastectomy Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

45 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Riphah medical center

Lahore, Punjab Province, 6400, Pakistan

Location status: Recruiting

Location contact

amara eman, MSPT(WH)

PRINCIPAL_INVESTIGATOR

hina gul, PhD*

CONTACT

[email protected]

03214979172

About this study

The study will be randomized controlled trial and will conducted in Shokat Khanam hospital and Anmol cancer hospital. Non-probability convenience sampling technique will be used and 48 participants will be recruited in study after randomization. The subjects will be divided into two group. Group A will receive myofascial release. Group B will receive myofascial release with resisted deep breathing. Both Group will receive Baseline treatment which is including transcutaneous electrical nerve stimulation. The total duration of treatment will be 12 weeks and there will be 2 sessions each week. The tools that will be used are Numeric Pain Rating Scale (NPRS) for pain, Circumferential limb measurements for chest mobility or lymph edema and Spirometer for respiratory efficiency. After data collection will be analyzed by using SPSS version 21.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Radiation therapy and chemotherapy was finished at least three months
  • 6 months after mastectomy for breast cancer being diagnosed without lymphedema or with stage 1 lymphedema
  • Complete unilateral Mastectomy
  • pain and having one or more of the following symptoms: heaviness, numbness, oppression, stiffness, alterations in the function, or mobility of the limited shoulder range of motion.

Exclusion criteria

  • Presence of shoulder pathologies for which surgical indications exist
  • Musculoskeletal injury in adjacent areas (shoulder or neck etc.)
  • bilateral surgery for the treatment of breast cancer
  • Bilateral lymphadenectomy
  • Open wounds on upper limbs
  • Circulatory disorders
  • History of shoulder surgery for reasons other than breast cancer.

Treatment and study plan

Resisted Deep Breathing

Other

The total duration of treatment will be 12 weeks and there will be 2 sessions each week

Myofascial Release

Other

The total duration of treatment will be 12 weeks and there will be 2 sessions each week

Primary outcomes

  1. Spirometer

    Time frame: 12th week

    The evaluation of pulmonary function will be performed using conventional spirometry with a Spirobank USB spirometer (Medical International Research, Rome, Italy). The directly measured parameters will include lung volumes, capacities, and flow rates, assessed through the procedures of slow vital capacity (SVC), forced vital capacity (FVC), and maximal voluntary ventilation (MVV), performed in this order

  2. Circumferential limb measurements

    Time frame: 12th week

    In the proposed study, upper limb volume will be measured using circumference measurements. The anatomical positions of the arm will be selected at 7 cm intervals, including the wrist (the slenderest part), 7 cm above the wrist (lower arm), 7 cm below the elbow (lower arm), at the elbow, 7 cm above the elbow (upper arm), and at the same level as the axilla (upper arm). To minimize measurement error, all measurements will be taken at a constant pressure, with participants seated in a position where the hips and knees are bent at 90 degrees.

  3. Numerical pain rating scale (NPRS)

    Time frame: 12th week

    Subjective pain will be measured using the Numerical pain Rating Scale (NPRS), which is the simplest and most commonly used pain assessment tool. Patients will be asked to mark a point on a line ranging from 0 (no pain) to 10 (worst imaginable pain) to indicate their pain intensity.

  4. Chest Mobility

    Time frame: 12th week

    Chest circumference at maximal voluntary inspiration (insp) and maximal voluntary expiration (expir), as well as chest expansion (CE) calculated as the difference between insp and expir will be measured in a sitting position using a tape marked in 0.1 cm increments at the level of the fourth intercostal space. Participants will be instructed about the procedure and asked to exhale fully and hold for expir, and inhale deeply and hold for insp. The highest insp and lowest expir values from three attempts will be recorded, and their difference will represent chest expansion

Study contacts

Contact information is provided by the study sponsor or research team.

imran amjad

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effect of Resisted Deep Breathing and Myofascial Release on Pain, Respiratory Efficiency, Chest Mobility and Lymph Edema in Postmastectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 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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