Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation (ACU)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.
Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.
Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.
Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Over 18 years of age
- Able to understand and read/write Swedish
Exclusion Criteria:
- No acupuncture training
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: acupuncture positive communication
Genuine acupuncture needles combined with positive communication regarding the expected treatment effects
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acupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth.
The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles.
When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle.
Otros nombres:
During the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: "Many acupuncture studies have shown excellent results concerning relaxation effects", "Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension".
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Comparador falso: sham acupuncture positive communication
Sham acupuncture needles combined with positive communication regarding the expected treatment effects
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During the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: "Many acupuncture studies have shown excellent results concerning relaxation effects", "Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension".
sham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20].
Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration.
A marking tube, identical for both acupuncture types, held the sham needle in place.
The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no "needle sensation" occurred, and then lifted the needles up from the skin.
Otros nombres:
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Comparador activo: acupuncture neutral communication
Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects
|
acupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth.
The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles.
When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle.
Otros nombres:
During the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: "During treatment you will just lie down and rest and I will not talk so much to you", "We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study",
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Comparador falso: sham acupuncture neutral communication
Sham acupuncture needles combined with neutral communication regarding the expected treatment effects
|
sham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20].
Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration.
A marking tube, identical for both acupuncture types, held the sham needle in place.
The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no "needle sensation" occurred, and then lifted the needles up from the skin.
Otros nombres:
During the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: "During treatment you will just lie down and rest and I will not talk so much to you", "We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study",
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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 from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)
Periodo de tiempo: approximately 5 minutes before treatment and approximately 5 minutes after treatment
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Subjective perception of relaxation measured with a 0-100 mm Visual analogue scale
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approximately 5 minutes before treatment and approximately 5 minutes after treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from before treatment to after treatment in subjective report of expectations (0-100 mm Visual analogue scale)
Periodo de tiempo: approximately 5 minutes before treatment and approximately 5 minutes after treatment
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Subjective perception of expectation measured with a 0-100 mm Visual analogue scale
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approximately 5 minutes before treatment and approximately 5 minutes after treatment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ACU 2013/80-31
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