Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.
2. september 2026 opdateret af: Lahore University of Biological and Applied Sciences
This randomized controlled trial aims to compare the effects of visual-feedback induced therapy and Active Release Technique on shoulder pain, lymphedema, and functional disability in post-mastectomy patients.
Participants will be randomly assigned to receive either conventional physiotherapy combined with Active Release Technique or conventional physiotherapy combined with visual-feedback therapy.
Outcomes will be measured at baseline and after 6 weeks of intervention.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Post-mastectomy patients frequently experience shoulder pain, restricted mobility, and lymphedema, leading to functional disability and reduced quality of life.
Conventional physiotherapy provides partial relief; however, innovative approaches such as visual-feedback therapy (mirror therapy) and Active Release Technique may offer improved outcomes.
This study evaluates and compares the effectiveness of these interventions in improving pain, limb swelling, and upper-limb function.
The findings may help identify optimal rehabilitation strategies for breast cancer survivors.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 0000
- University of biological and applied sciences
-
-
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
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Female patients aged 40-65 years.
- History of unilateral mastectomy performed at least 2 months prior.
- Persistent shoulder pain (Numeric Pain Rating Scale 4-7).
- Reduced shoulder range of motion or functional limitation affecting daily activities.
- Mild to moderate lymphedema of the affected upper limb .
Exclusion Criteria:
- History of neurological disorders affecting motor function (e.g., stroke, MS).
- Previous shoulder surgery unrelated to mastectomy.
- Active infection or open wounds in the affected limb.
- Already developed frozen shoulder in diabetic patient.
- Severe lymphedema requires intensive medical management.
- Cognitive impairment prevents participation in therapy.
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 |
|---|---|
|
Eksperimentel: Active Release Technique
Participants will receive a combination of conventional physiotherapy and Active Release Technique (ART) for 40-60 minutes per session, three times per week, over 6 consecutive weeks.
The conventional physiotherapy includes hot pack therapy for 15 minutes to reduce pain and improve tissue extensibility, followed by 25-30 minutes of exercise therapy.
Exercises target shoulder range of motion (flexion, abduction, external rotation), strengthening of rotator cuff and scapular stabilizers, stretching of pectoralis major and minor, deltoid, biceps, and upper trapezius, and functional tasks such as reaching, lifting, and daily activity simulations.
Exercises start with three repetitions and stretches held for 10-15 seconds, with weekly progression based on patient tolerance.
|
Participants in the experiment group 1 will receive a combination of conventional physiotherapy and Active Release Technique (ART) for 40-60 minutes per session, three times per week, over 6 consecutive weeks.
The conventional physiotherapy includes hot pack therapy for 15 minutes to reduce pain and improve tissue extensibility, followed by 25-30 minutes of exercise therapy.
Exercises target shoulder range of motion (flexion, abduction, external rotation), strengthening of rotator cuff and scapular stabilizers, stretching of pectoralis major and minor, deltoid, biceps, and upper trapezius, and functional tasks such as reaching, lifting, and daily activity simulations.
Exercises start with three repetitions and stretches held for 10-15 seconds, with weekly progression based on patient tolerance.
|
|
Aktiv komparator: Visual-Feedback Induced Therapy
Participants in the experimental group 2 will receive the same conventional physiotherapy as the experimental group 1, plus Visual-Feedback Induced Therapy (VFIT) for 40-60 minutes per session, three times per week, for 6 weeks.
VFIT uses mirror during shoulder and upper-limb exercises, allowing patients to observe the unaffected limb performing movements while performing symmetrical movements with the affected limb.
Exercises focus on shoulder flexion, abduction, rotation, and functional reaching tasks, aiming to correct abnormal movement patterns, reduce compensatory strategies, and enhance central motor control.
|
Participants in the experimental group 2 will receive the same conventional physiotherapy as the experimental group 1, plus Visual-Feedback Induced Therapy (VFIT) for 40-60 minutes per session, three times per week, for 6 weeks.
VFIT uses mirror during shoulder and upper-limb exercises, allowing patients to observe the unaffected limb performing movements while performing symmetrical movements with the affected limb.
Exercises focus on shoulder flexion, abduction, rotation, and functional reaching tasks, aiming to correct abnormal movement patterns, reduce compensatory strategies, and enhance central motor control.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity
Tidsramme: From enrollment to 6 weeks.
|
Pain numeric scale: The Numeric Pain Rating Scale is an 11-point scale from 0 to 10 used to measure pain intensity. |
From enrollment to 6 weeks.
|
|
Shoulder pain and disability
Tidsramme: From baseline to 6 weeks.
|
The Shoulder Pain and Disability Index is a 13-item, patient-reported questionnaire.
Percentage score (0% to 100%).
|
From baseline to 6 weeks.
|
|
Limb volume
Tidsramme: From baseline to 6 weeks
|
Lymphedema measuring tape: A lymphedema measuring tape is a used to measuring circumference of shoulder. Minimum: Grade 1 (Mild - less than 20% volume increase in the limb)Maximum: Grade 4 (Gigantic - massive deformity exceeding 50% to 100% volume increase) |
From baseline to 6 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
16. juli 2026
Primær færdiggørelse (Faktiske)
30. juli 2026
Studieafslutning (Faktiske)
15. august 2026
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UBAS/ERB/26/043010
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
baseline participants
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .