- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02691208
Acupuncture and Breast Cancer Rehabilitation (ACUP)
Effectiveness of Acupuncture in Rehabilitation of Physical and Functional Disorders of Women Undergoing Breast câncer Surgery
The patients were divided into two randomized groups with 24 patients per group, which were given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes acupuncture using predefined points.
The patients were assessed at baseline, after five weeks and at the end of 10 weeks. Responded to an evaluation form about their registration and social data. The physical examination included the assessment of shoulder range of motion, shoulder muscle strength, circumference of the upper limbs and the presence of pain. Questionnaires of quality of life, upper limb function and depression.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
They were included in this study patients undergoing surgical treatment for breast cancer, radical or conservative, and to produce pain in the region of the shoulder girdle and upper limb, including thoracic and cervical spine after three months of surgery. Patients over the age of 18 years and level of pain ≥ 3 on the Visual Analogue Scale (VAS). patients with bilateral breast surgery were excluded, metastatic disease, vascular disorders and tactile sensitivity, with diabetes mellitus type I and II uncompensated and with lower level of education than four years. The patients were divided into two randomized groups with 24 patients per group, which were given weekly treatment for 10 weeks, one group treated with Kinesiotherapy lasting 30 minutes and the other group followed Kinesiotherapy the same protocol for another 30 minutes acupuncture using predefined points.
The patients were assessed at baseline, after five weeks and at the end of 10 weeks. Responded to an evaluation form about their registration and social data. The physical examination included the assessment of shoulder range of motion, shoulder muscle strength, circumference of the upper limbs and the presence of pain. questionnaires application EORC QLQ C30 BECK and DASH.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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São Paulo, Brasilien, 04024002
- Federal University of São Paulo
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- underwent surgical treatment of breast cancer, radical or conservative,
- pain in scapular girdle, in the thoracic or cervical spine, after three months surgery.
- level of pain ≥ 3 in the Visual Analogue Scale
Exclusion Criteria:
- bilateral breast surgery,
- metastatic disease,
- vascular and tactile sensitivity disorders,
- uncompensated diabetes mellitus type I and II
- lower education level than four years.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Group I Kinesiotherapy
women with pain treated with a predefinided exercises protocol of 30 minutes.
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Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.
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Experimental: Group II Acupuncture
women with pain treated with a predefinided exercises protocol of 30 minutes followed by 30 minutes of acupuncture, used in predefined points
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Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes plus 30 minutes of classical acupuncture using predefined points.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Result of rehabilitation about pain, Shoulder Range of Motion, lymphedema presence, upper limb function, Depressive symptoms, Quality of life and Muscle strength with kinesioterapy and acupuncture
Zeitfenster: two years
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two years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Gil Facina, PhD, BRazil:Research committee - Recruting
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FUSaoPaulo PT 2
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