- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04990960
Experimental Study About Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary Dissection
2 augusti 2021 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Mantova, Italien, 46100
- Laura Mutti
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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
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Age > 18years;
- Patients able to sign informed consent;
- Patients who underwent ALND surgery for breast cancer;
- Presence of cords associated with A.W.S.;
- Surgeon examination carried no more than 10 days after the operation.
Exclusion Criteria:
1. Presence of cords after AD due to Melanoma metastasis.
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: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
Andra namn:
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Average flexion
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Average abduction
Tidsram: 5 weeks
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Abduction: from the same start-position (0°), the patient moves the arm away from the leg (complete at 180°)
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5 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Laura Mutti, Hospital "Carlo Poma" - Mantova - Italy
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)
1 oktober 2017
Primärt slutförande (Faktisk)
30 september 2019
Avslutad studie (Faktisk)
30 oktober 2019
Studieregistreringsdatum
Först inskickad
28 april 2021
Först inskickad som uppfyllde QC-kriterierna
2 augusti 2021
Första postat (Faktisk)
5 augusti 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 78-2017-SPERIM_ALTRO-MN28
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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