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Acupuncture and Breast Cancer Rehabilitation (ACUP)

2. juni 2016 opdateret af: Gil Facina, Federal University of São Paulo

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • São Paulo, Brasilien, 04024002
        • Federal University of São Paulo

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group I Kinesiotherapy
women with pain treated with a predefinided exercises protocol of 30 minutes.
Andet: Kinesiotherapy
Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.
Eksperimentel: 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
Andet: Acupuncture
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: two years
  1. Presence of pain by Visual Analog Scale of Pain (VAS).
  2. Shoulder Range of Motion (ROM) by active goniometry of flexion movements, extension, adduction, abduction, internal rotation and external rotation
  3. lymphedema presence through top member perimetry.
  4. upper limb function through the DASH questionnaire.
  5. Depressive symptoms through BECK questionnaire.
  6. Quality of life through the EORTC questionnaire.
  7. Muscle strength of flexion, extension, adduction, abduction, internal rotation and shoulder external rotation with the Hand Held Dynamometer 01,163 model of Lafayette Instrument Company.
two years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of São Paulo

Efterforskere

  • Ledende efterforsker: Gil Facina, PhD, BRazil:Research committee - Recruting

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

1. august 2011

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

11. februar 2016

Først indsendt, der opfyldte QC-kriterier

21. februar 2016

Først opslået (Skøn)

25. februar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FUSaoPaulo PT 2

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 .

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