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Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

44

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 0000
        • University of biological and applied sciences

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain intensity
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juli 2026

Primärt slutförande (Faktisk)

30 juli 2026

Avslutad studie (Faktisk)

15 augusti 2026

Studieregistreringsdatum

Först inskickad

9 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 juli 2026

Första postat (Faktisk)

22 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • UBAS/ERB/26/043010

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

baseline participants

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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