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Exercise and Steroid in Knee Osteoarthritis

5. maj 2014 opdateret af: Henning Bliddal, Frederiksberg University Hospital

Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial

Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and disability. As no cure exists, management aims to reduce pain, improve function, and enhance quality of life. The recommended hierarchy of management should consist of exercise in first line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.

The effect size of exercise therapy is of the same magnitude as most pharmacological treatments but is often without adverse effects. Local pharmacological treatment of the afflicted knee joint is recommended by means of intra-articular injections of corticosteroids, which is considered as a standard medical treatment of knee OA and are included in established guidelines for management of knee OA. While the two treatment approaches have been investigated separately in numerous clinical trials, the efficacy of a combined pharmacological and non-pharmacological approach is not known, despite the high rank of such combined treatment approach on the recommended hierarchy of management.

The purpose of this study is to assess the effects of exercise therapy in combination with intra-articular corticosteroid injections on patient reported pain and function in patients with knee OA.

The hypothesis is that the combined treatment approach (exercise therapy preceded by intra-articular injection of corticosteroid) enhances the clinical outcome compared to exercise therapy preceded by a placebo injection.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

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, 2000
        • The Parker Institute, Frederiksberg 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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age 40 years or above
  • clinical knee osteoarthritis verified by radiography
  • pain during level walking of at least 40 mm on a 0-100 mm visual analog scale
  • clinical signs of local inflammation
  • body mass index between 20 and 35

Exclusion Criteria:

  • Exercise therapy within 3 months
  • Intraarticular corticosteroid within 3 months
  • Counter indications to exercise
  • Counter indications to corticosteroid
  • pregnant or breast feeding
  • Auto immune disease
  • Planned surgery in the study period
  • significant cardiovascular disease
  • significant neuroloigal disease
  • significant psychiatric disease
  • regional pain syndromes (e.g. fibromyalgia)
  • spinal nerve root compression syndromes

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intraarticular steroid + Exercise
Intra-articular corticosteroid treatment with subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
Medicin: Intraarticular steroid
1 ml methylprednisolon corticosteroid (40 mg Depo-Medrol®) mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided.
Andet: Exercise therapy

The exercise is commenced 2 weeks after injection.

The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees.

In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities.
Aktiv komparator: Intraarticular saline+Exercise
Combined intra-articular saline injection and subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
Andet: Exercise therapy

The exercise is commenced 2 weeks after injection.

The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees.

In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities.

Medicin: Intraarticular saline
1 ml isotonic saline mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee pain
Tidsramme: Change from baseline to week 14
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Change from baseline to week 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee pain
Tidsramme: Change from baseline to week 2 and week 26
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Change from baseline to week 2 and week 26
Knee symptoms
Tidsramme: Change from baseline to week 2, 14, and 26
Self-reported knee symptoms, knee related function, quality of life and, function during sports and recreation assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Change from baseline to week 2, 14, and 26
Functional pain test
Tidsramme: Change from baseline to week 14, and 26
Knee OA pain is associated with movement of the afflicted knee. Therefore we assess pain intensity and movement tolerance during repeated squatting. The test has 3 outcomes: 1) The number of pain free squatting movements that can be done in 30 seconds; 2) the number of painful squatting movements that can be done in 30 seconds; and 3) the average pain intensity during the squatting movements assessed on a 0-10 numeric rating scale.
Change from baseline to week 14, and 26
Knee Muscle strength
Tidsramme: Change from baseline to week 14, and 26
Assessed by an isokinetic dynamometer
Change from baseline to week 14, and 26
6 minute walk distance
Tidsramme: Change from baseline to week 14, and 26
The distance covered during 6 minutes of fast walking
Change from baseline to week 14, and 26
Systemic markers of inflammation in blood
Tidsramme: Change from baseline to week 14, and 26
Blood sample
Change from baseline to week 14, and 26
MRI based inflammation
Tidsramme: Change from baseline to week 14, and 26
To assess the severity and extent of local inflammation in the knee and surrounding tissues magnetic resonance imaging (MRI) are done before and after intravenous injection of a Gadolinium contrast agent. Contrast agents are only administered to participants with normal kidney function assessed from a standard blood sample
Change from baseline to week 14, and 26

Samarbejdspartnere og efterforskere

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

Sponsor

Frederiksberg University Hospital

Efterforskere

  • Studiestol: Marius Henriksen, PhD, Frederiksberg University Hospital

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

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

16. september 2013

Først indsendt, der opfyldte QC-kriterier

16. september 2013

Først opslået (Skøn)

19. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 101.04
  • 2012-002607-18 (EudraCT nummer)

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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