Post Mastectomy LymphedemaNCT07576270
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
A study testing Resisted Deep Breathing and Myofascial release in people with Post Mastectomy Lymphedema, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Mastectomy Lymphedema
- What is being tested?
- Resisted Deep Breathing and Myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah medical center
Lahore, Punjab Province, 6400
hina gul, PhD*, 03214979172, hina.gul@riphah.edu.pk
amara eman, MSPT(WH)
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Mastectomy Lymphedema
- Being tested
- Resisted Deep Breathing, Myofascial release
- Keywords
- Chest, Lymphedema, Post mastectomy, Myofasical release, Pain
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resisted Deep BreathingOther
The total duration of treatment will be 12 weeks and there will be 2 sessions each week
Myofascial releaseOther
The total duration of treatment will be 12 weeks and there will be 2 sessions each week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Resisted Deep Breathing; Other: 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 Receives: Other: Myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Mastectomy LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576270
- Sponsor's protocol ID
- REC/RCR & AHS/25/0507
- Status last verified
- Sep 2026
- First submitted
- 4 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vijayakumar C, Jain A, Kalaranjani M, Kumbhar US, Kumar N, Sreenath GS. 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. Sultan Qaboos Univ Med J. 2025 May 2;25(1):328-335. doi: 10.18295/2075-0528.2841.
PubMed 40641717Sun 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. Support Care Cancer. 2025 Mar 12;33(4):270. doi: 10.1007/s00520-025-09259-2.
PubMed 40072712Lara-Palomo IC, Castro-Sanchez AM, Cordoba-Pelaez MM, Albornoz-Cabello M, Ortiz-Comino L. Effect of Myofascial Therapy on Pain and Functionality of the Upper Extremities in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Apr 21;18(9):4420. doi: 10.3390/ijerph18094420.
PubMed 33919315Kim Y, Park EY, Lee H. The effect of myofascial release in patients with breast cancer-related lymphedema: a cross-over randomized controlled trial. Eur J Phys Rehabil Med. 2023 Feb;59(1):85-93. doi: 10.23736/S1973-9087.22.07698-5. Epub 2023 Jan 13.
PubMed 36637800AMANY RAW, FATMA SA, NANCY HA, ASHRAF EEJTMJoCU. Effect of Resisted Deep Breathing on Post Mastectomy Lymphedema. 2024;91(12):1443-8.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Resisted Deep Breathing and Myofascial Release on Pain, Respiratory Efficiency, Chest Mobility and Lymph Edema in Postmastectomy
- ClinicalTrials.gov ID
- NCT07576270
- Acronym / sponsor ID
- REC/RCR & AHS/25/0507
- Conditions
- Post Mastectomy Lymphedema
- Keywords
- Chest, Lymphedema, Post mastectomy, Myofasical release, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resisted Deep Breathing & Myofascial release | Experimental | Other: Resisted Deep Breathing, Other: Myofascial releaseMyofascial 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 |
| Myofascial release | Active comparator | Other: Myofascial releaseMyofascial 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 |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resisted Deep BreathingThe total duration of treatment will be 12 weeks and there will be 2 sessions each week | Other | Resisted Deep Breathing & Myofascial release |
| Myofascial releaseThe total duration of treatment will be 12 weeks and there will be 2 sessions each week | Other | Myofascial release, Resisted Deep Breathing & Myofascial release |
Primary outcome
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
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 40641717Vijayakumar C, Jain A, Kalaranjani M, Kumbhar US, Kumar N, Sreenath GS. 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. Sultan Qaboos Univ Med J. 2025 May 2;25(1):328-335. doi: 10.18295/2075-0528.2841.
- Background: PubMed 40072712Sun 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. Support Care Cancer. 2025 Mar 12;33(4):270. doi: 10.1007/s00520-025-09259-2.
- Background: PubMed 33919315Lara-Palomo IC, Castro-Sanchez AM, Cordoba-Pelaez MM, Albornoz-Cabello M, Ortiz-Comino L. Effect of Myofascial Therapy on Pain and Functionality of the Upper Extremities in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Apr 21;18(9):4420. doi: 10.3390/ijerph18094420.
- Background: PubMed 36637800Kim Y, Park EY, Lee H. The effect of myofascial release in patients with breast cancer-related lymphedema: a cross-over randomized controlled trial. Eur J Phys Rehabil Med. 2023 Feb;59(1):85-93. doi: 10.23736/S1973-9087.22.07698-5. Epub 2023 Jan 13.
- BackgroundAMANY RAW, FATMA SA, NANCY HA, ASHRAF EEJTMJoCU. Effect of Resisted Deep Breathing on Post Mastectomy Lymphedema. 2024;91(12):1443-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
hina gul, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resisted Deep Breathing and Myofascial release in people with Post Mastectomy Lymphedema, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometer (time frame: 12th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07576270, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.