Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Progressive Active Exercise After Surgical Rotator Cuff Repair

20. november 2020 opdateret af: Marius Henriksen

Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up

Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.

A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition.

The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work.

Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.

Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

82

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2400
        • Bispebjerg and Frederiksberg Hospitals
      • Copenhagen, Danmark, 2730
        • Herlev and Gentofte Hospital

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

Alle

Beskrivelse

Inclusion Criteria:

  • Women and men above 18 years
  • Operated due to traumatic full thickness RC-tear
  • Involving supraspinatus (full thickness and width)
  • Present with reduced arm elevation strength and pain
  • Clinical diagnosis verified by arthroscopy
  • Fully repairable RC-tear

Exclusion Criteria:

  • Patients with non-traumatic RC-tears of the shoulder
  • Patients with isolated teres minor or subscapularis tear
  • Patients with partial thickness/ width tear
  • Prior shoulder surgery (all shoulder joints)
  • Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis
  • Inability to speak or read Danish
  • Inability to perform and maintain the physical training
  • Other condition negatively influencing compliance or conditions that in the opinion of the investigator puts a potential participant at increased risk or otherwise makes him/her unsuitable for participation.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Progressive early passive and active movement
Active exercise starts one week after surgery.
Adfærdsmæssigt: Progressive early passive and active movement
Post-surgical physical therapy including active exercise
Aktiv komparator: Limited early passive movement
Active exercise starts six weeks after surgery.
Adfærdsmæssigt: Limited early passive movement
Post-surgical physical therapy including passive mobilisation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Tidsramme: 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Tidsramme: 6 and 52 weeks
6 and 52 weeks
Change from baseline in Disability Arm Shoulder Hand (DASH)
Tidsramme: 6, 12 and 52 weeks
6, 12 and 52 weeks
Global Rating Scale (GRS)
Tidsramme: 6, 12 and 52 weeks
Global perceived treatment effect
6, 12 and 52 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Tidsramme: 6, 12 and 52 weeks
6, 12 and 52 weeks
Change from baseline in Shoulder Range of Motion (ROM)
Tidsramme: 6, 12 and 52 weeks
6, 12 and 52 weeks
Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
Tidsramme: 12 and 52 weeks
Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.
12 and 52 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ultrasound imaging of rotator cuff tendons
Tidsramme: 6 weeks
Assessment of possible re-ruptures of tendons
6 weeks
Ultrasound Imaging of rotator cuff tendons
Tidsramme: 52 weeks
Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons
52 weeks
Return to work
Tidsramme: 6 and 52 weeks
Patient-reported time (days) til return to full work capacity.
6 and 52 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Marius Henriksen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

26. februar 2017

Primær færdiggørelse (Faktiske)

10. maj 2020

Studieafslutning (Faktiske)

10. maj 2020

Datoer for studieregistrering

Først indsendt

15. november 2016

Først indsendt, der opfyldte QC-kriterier

17. november 2016

Først opslået (Skøn)

21. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FYS012

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Rivning af rotatormanchet

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Senegal

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner