NCT07576270

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2025Jul 2026

Study Start

First participant enrolled

October 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

ChestLymphedemaPost mastectomyMyofasical releasePain

Outcome Measures

Primary Outcomes (4)

  • Spirometer

    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

    12th week

  • Circumferential limb measurements

    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.

    12th week

  • Numerical pain rating scale (NPRS)

    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.

    12th week

  • Chest Mobility

    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

    12th week

Study Arms (2)

Resisted Deep Breathing & Myofascial release

EXPERIMENTAL

Myofascial release is a hands-on therapy aimed at relieving pain and tightness in the fascia, the connective tissue surrounding muscles, by targeting trigger points and stiff areas and Resisted Deep Breathing (RDB) is a physiotherapy breathing technique used to improve respiratory muscle strength, lung expansion, and ventilation efficiency

Other: Resisted Deep BreathingOther: Myofascial release

Myofascial release

ACTIVE COMPARATOR

Myofascial release is a hands-on therapy aimed at relieving pain and tightness in the fascia, the connective tissue surrounding muscles, by targeting trigger points and stiff areas

Other: Myofascial release

Interventions

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

Resisted Deep Breathing & Myofascial release

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

Myofascial releaseResisted Deep Breathing & Myofascial release

Eligibility Criteria

Age45 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmastectomy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Radiation therapy and chemotherapy was finished at least three months
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah medical center

Lahore, Punjab Province, 6400, Pakistan

RECRUITING

Related Publications (5)

  • Vijayakumar C, Jain A, Kalaranjani M, Kumbhar US, Kumar AN, Sreenath GJSQUMJ. Effectiveness of Myofascial Release Compared to Manual Lymphatic Drainage in Reducing Post-Treatment Shoulder Pain and Stiffness Among Patients Who Underwent Breast Cancer Surgery and Adjuvant Radiotherapy: Randomised controlled trial. 2025;25(1):328-35.

    BACKGROUND
  • Sun R, Liao Y. The impact of combined Gua Sha and myofascial release techniques on upper limb dysfunction in patients with breast cancer and axillary web syndrome: a prospective case series study. Supportive Care in Cancer. 2025;33(4):270

    BACKGROUND
  • Lara-Palomo IC, Castro-Sánchez AM, Córdoba-Peláez MM, Albornoz-Cabello M, Ortiz-Comino LJIJoER, Health P. Effect of myofascial therapy on pain and functionality of the upper extremities in breast cancer survivors: A systematic review and meta-analysis. 2021;18(9):4420.

    BACKGROUND
  • Yena K, Eun YP, Haneul LJEJop, Medicine r. The effect of myofascial release in patients with breast cancer-related lymphedema: a cross-over randomized controlled trial. 2023;59(1):85.

    BACKGROUND
  • AMANY RAW, FATMA SA, NANCY HA, ASHRAF EEJTMJoCU. Effect of Resisted Deep Breathing on Post Mastectomy Lymphedema. 2024;91(12):1443-8.

    BACKGROUND

MeSH Terms

Conditions

Breast Cancer LymphedemaLymphedemaPain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • hina gul, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations