- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07576270
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
4. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
48
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: imran amjad
- Telefonnummer: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 6400
- Rekruttering
- Riphah medical center
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Kontakt:
- hina gul, PhD*
- Telefonnummer: 03214979172
- E-mail: hina.gul@riphah.edu.pk
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Ledende efterforsker:
- amara eman, MSPT(WH)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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
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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
|
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Aktiv komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spirometer
Tidsramme: 12th week
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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
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12th week
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Circumferential limb measurements
Tidsramme: 12th week
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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.
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12th week
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Numerical pain rating scale (NPRS)
Tidsramme: 12th week
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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.
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12th week
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Chest Mobility
Tidsramme: 12th week
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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
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12th week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: hina gul, PhD*, Riphah International University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2025
Primær færdiggørelse (Anslået)
1. juni 2026
Studieafslutning (Anslået)
1. juli 2026
Datoer for studieregistrering
Først indsendt
4. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. maj 2026
Først opslået (Faktiske)
8. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Postoperative komplikationer
- Patologiske processer
- Lymfesygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Brystkræft lymfødem
- Smerte
- Lymfødem
- Terapeutik
- Komplementære terapier
- Fysioterapimodaliteter
- Rehabilitering
- Terapi, blødt væv
- Muskuloskeletale manipulationer
- Massage
- Myofascial frigørelsesbehandling
Andre undersøgelses-id-numre
- REC/RCR & AHS/25/0507
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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