Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

18 april 2017 uppdaterad av: Duke University

Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis

The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with OA of the knee.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

222

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Connecticut
      • Derby, Connecticut, Förenta staterna, 06418
        • Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital
    • New Jersey
      • Morristown, New Jersey, Förenta staterna, 07960
        • Atlantic Health System -- Atlantic Health Integrative Medicine
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke University Medical Center- Duke Integrative Medicine

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

35 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 35 years of age or greater.
  • Written confirmation of OA of the knee as provided by the participant's physician.
  • Radiographically-established OA of the knee.
  • Pre-randomization rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale).
  • Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
  • Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.

  • American College of Rheumatology defined OA of the knee; specifically:

    a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness < 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth

Exclusion Criteria:

  • Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
  • Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
  • Signs or history of kidney or liver failure.
  • Presence of asthma requiring the use of corticosteroid treatment.
  • Use of oral corticosteroids within the past four weeks.
  • Use of intra-articular knee depo-corticosteroids with the past three months.
  • Use of intra-articular hyaluronate with the past six months.
  • Arthroscopic surgery of the knee within the past year.
  • Significant injury to the knee within the past six months.
  • Presence of a rash or open wound over the knee.
  • Unable to satisfy the treatment and follow-up requirements.
  • Unable to provide written informed consent.
  • Currently receiving massage therapy on a regular basis (at least twice a month).
  • Knee replacement of study knee (ok if the knee not being studied has been replaced).
  • History of participating in the EMBARK Phase I or II studies.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Swedish Massage
Swedish massage for one hour, once per week, for eight weeks. At week 10, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), and 50% will be randomized to Usual Care.
Procedur: Massage Therapy
Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Andra namn:
  • Vanlig vård
Aktiv komparator: Light Touch Bodywork
Light-touch bodywork for one hour, once per week, for eight weeks. At week 10, 50% of the patients will be randomized to a maintenance dose (one hour of light-touch massage every two weeks, and 50% will be randomized to Usual Care.
Procedur: Massage Therapy
Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Andra namn:
  • Vanlig vård
Övrig: Usual Care
Those initially randomized to the usual care control will be rolled into the Swedish massage intervention (one hour of Swedish massage, once/week for eight weeks) at week 25. At week 34, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), while 50% will be randomized back to Usual Care.
Procedur: Massage Therapy
Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Andra namn:
  • Vanlig vård

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
Tidsram: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis through 24 questions. WOMAC 3.1 is available in 65 languages using either a five-point Likert scale or a 100 mm visual analog scale. The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Pain: The Visual Analog Scale (VAS)
Tidsram: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Used to measure pain sensation intensity evoked by nociceptive stimuli. Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale. Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable). The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Change in Pain: PROMIS Pain Interference Questionnaire
Tidsram: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status. The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Change in Joint Flexibility
Tidsram: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Joint flexibility is defined as the range of motion (ROM) allowed at the knee. The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. This is measured using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint.
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Change in Physical Function
Tidsram: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Samarbetspartners

National Center for Complementary and Integrative Health (NCCIH)

Utredare

  • Huvudutredare: Adam Perlman, MD, MPH, Duke University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

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

1 juni 2012

Primärt slutförande (Faktisk)

1 juni 2015

Avslutad studie (Faktisk)

1 juni 2015

Studieregistreringsdatum

Först inskickad

7 februari 2012

Först inskickad som uppfyllde QC-kriterierna

17 februari 2012

Första postat (Uppskatta)

23 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 april 2017

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00032894
  • 7R01AT004623-04 (U.S.S. NIH-anslag/kontrakt)

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 .

Kliniska prövningar på Massage Therapy

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Bahrain

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera