- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01537484
Exploring Massage Benefits for Arthritis of the Knee (EMBARK)
18 de abril de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
222
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Connecticut
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Derby, Connecticut, Estados Unidos, 06418
- Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07960
- Atlantic Health System -- Atlantic Health Integrative Medicine
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center- Duke Integrative Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
35 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Otros nombres:
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Comparador activo: 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.
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Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Otros nombres:
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Otro: 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.
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Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
Periodo de tiempo: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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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
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Pain: The Visual Analog Scale (VAS)
Periodo de tiempo: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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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."
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Change in Pain: PROMIS Pain Interference Questionnaire
Periodo de tiempo: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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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.
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Change in Joint Flexibility
Periodo de tiempo: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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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.
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Change in Physical Function
Periodo de tiempo: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Adam Perlman, MD, MPH, Duke University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Perlman AI, Sabina A, Williams AL, Njike VY, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized controlled trial. Arch Intern Med. 2006 Dec 11-25;166(22):2533-8. doi: 10.1001/archinte.166.22.2533.
- Perlman AI, Ali A, Njike VY, Hom D, Davidi A, Gould-Fogerite S, Milak C, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial. PLoS One. 2012;7(2):e30248. doi: 10.1371/journal.pone.0030248. Epub 2012 Feb 8.
- Perlman A, Fogerite SG, Glass O, Bechard E, Ali A, Njike VY, Pieper C, Dmitrieva NO, Luciano A, Rosenberger L, Keever T, Milak C, Finkelstein EA, Mahon G, Campanile G, Cotter A, Katz DL. Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial. J Gen Intern Med. 2019 Mar;34(3):379-386. doi: 10.1007/s11606-018-4763-5. Epub 2018 Dec 12.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2012
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
7 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
17 de febrero de 2012
Publicado por primera vez (Estimar)
23 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
18 de abril de 2017
Última verificación
1 de agosto de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00032894
- 7R01AT004623-04 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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