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Experimental Study About Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection

2. august 2021 oppdatert av: Laura Mutti, Ospedale "Carlo Poma" - Mantova

Experimental Study About Efficacy Of Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection In Breast Cancer

BACKGROUND Dissection and removal of Lymph nodes in the Axilla (ALND) remains a method used in breast cancer management across the world. Post- surgical scar tissue that forms in this dissection is therefore beyond the linear scar, is characterized by less elasticity than healthy tissue and can over time, because of the anatomical location, cause significant limitations of the Active Range of Motion (AROM) of the scapulohumeral joint. After this procedure it's possible that Axillary Web Syndrome (AWS) occurs. This study discusses the physiotherapy management of patients with AWS. The primary objective of the study was to verify direct and indirect changes to AWS cords with two treatment methods at a single breast cancer rehabilitation setting: Physiotherapist 's work Vs. Self-treatment.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Breast cancer is the most common form of cancer among women. Axillary surgical procedures have reported, with post-operative morbidity of bleeding, lymphedema and shoulder pain, also the rather underestimated Axillary Web Syndrome. The study shows that the reduction of the problems linked to the Syndrome such as pain in shoulder Abduction and Flexion and inability in everyday life is possible with an early and competent treatment. Two different approaches to the Syndrome were investigated. The patients were divided in two groups. Good results were obtained within 5 weeks since the appearance of AWS with both of them but if the Physiotherapist is able to teach the convenient exercises, the selftreatment seemed to have the best outcome. This fact can change the awareness that an early approach is necessary inside the path to recovery. In the last years the Axillary Web Syndrome was the topic of many studies: the etiology, its clinical diagnosis, the relation with lymphedema…But the treatment was often reported like a combination of different techniques without indications about kinds, times. Instead the investigators examined a detailed procedure, the same in both groups. The work was different only as regards the cords treatment. This fact shows the value of a comprehensive treatment for neck, shoulder, breast and two different but specific works on the Axillary Web Syndrome. For these reasons its publishing could be important for all the professionals working with women after Surgery for breast cancer and metastatic lymphnodes.

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Mantova, Italia, 46100
        • Laura Mutti

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. Age > 18years;
  2. Patients able to sign informed consent;
  3. Patients who underwent ALND surgery for breast cancer;
  4. Presence of cords associated with A.W.S.;
  5. Surgeon examination carried no more than 10 days after the operation.

Exclusion Criteria:

1. Presence of cords after AD due to Melanoma metastasis.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Physiotherapist
The Physiotherapist worked on adhered breast scars, stiffness in neck and arm movements and actively worked on AWS cords with gentle extensions and / or energetic detachment maneuvers. No self-treatment methods were offered and required of the subject.
During each session (45 minutes)the patient was assessed and trained in self-treatment exercises assigned to treat their cords. This later method was chosen to ensure regular participation in their exercises and early correction of any inaccuracies in the implementation of the exercises regarding AWS treatment . Or the Physiotherapist worked actively on cords with soft or vigorous stretching.
Andre navn:
  • Selftreatment
Eksperimentell: Self-treatment
The Physiotherapist worked on adhered breast scars, stiffness in neck and arm movements. During each session the patient was also assessed and trained in self-treatment exercises assigned to treat their cords. Subjects were trained to perform self-treatment extension exercises with four exercises selected by the Physiotherapist
During each session (45 minutes)the patient was assessed and trained in self-treatment exercises assigned to treat their cords. This later method was chosen to ensure regular participation in their exercises and early correction of any inaccuracies in the implementation of the exercises regarding AWS treatment . Or the Physiotherapist worked actively on cords with soft or vigorous stretching.
Andre navn:
  • Selftreatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Average flexion
Tidsramme: 5 weeks

Starting position:the patient is laying on the table with the arm placed on the table and the hand opened touching the side with the palm (0° position).

Flexion: the patient raises the arm towards the headboard (complete at 180°) The movements had been measured with a standard goniometer.

5 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Average abduction
Tidsramme: 5 weeks
Abduction: from the same start-position (0°), the patient moves the arm away from the leg (complete at 180°)
5 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Laura Mutti, Hospital "Carlo Poma" - Mantova - Italy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2017

Primær fullføring (Faktiske)

30. september 2019

Studiet fullført (Faktiske)

30. oktober 2019

Datoer for studieregistrering

Først innsendt

28. april 2021

Først innsendt som oppfylte QC-kriteriene

2. august 2021

Først lagt ut (Faktiske)

5. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 78-2017-SPERIM_ALTRO-MN28

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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