- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07576270
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
May 4, 2026 updated by: Riphah International University
Combined Effect of Resisted Deep Breathing and Myofascial Release on Pain, Respiratory Efficiency, Chest Mobility and Lymph Edema 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 6400
- Recruiting
- Riphah medical center
-
Contact:
- hina gul, PhD*
- Phone Number: 03214979172
- Email: hina.gul@riphah.edu.pk
-
Principal Investigator:
- amara eman, MSPT(WH)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resisted Deep Breathing & Myofascial release
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
|
The total duration of treatment will be 12 weeks and there will be 2 sessions each week
The total duration of treatment will be 12 weeks and there will be 2 sessions each week
|
|
Active Comparator: Myofascial release
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
|
The total duration of treatment will be 12 weeks and there will be 2 sessions each week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12th week
|
|
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.
|
12th week
|
|
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.
|
12th week
|
|
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
|
12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hina gul, PhD*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
- 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.
- 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.
- AMANY RAW, FATMA SA, NANCY HA, ASHRAF EEJTMJoCU. Effect of Resisted Deep Breathing on Post Mastectomy Lymphedema. 2024;91(12):1443-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
May 4, 2026
First Submitted That Met QC Criteria
May 4, 2026
First Posted (Actual)
May 8, 2026
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Lymphatic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Breast Cancer Lymphedema
- Pain
- Lymphedema
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
- Myofascial Release Therapy
Other Study ID Numbers
- REC/RCR & AHS/25/0507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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