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Low-back Pain During Pregnancy and Its Psycho-social Implications

20 de diciembre de 2020 actualizado por: Come Collaboration

Low-back Pain During Pregnancy and Its Psycho-social Implications. The Role of the Osteopathic Manipulative Treatment Within Its Multi-disciplinary Management. A Randomised Controlled Study

Pregnancy-related pelvic girdle pain (PPP) and pregnancy-related lumbar pain (PLBP) are two distinct symptoms, which can occur together as lumbar-pelvic pain.The primary objective is to measure the impact of osteopathic manipulative treatment on pregnancy-related lumbar and pelvic pain. The secondary objective is to study the interaction between pain and psycho-social factors during the gestational period.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

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.

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

18 años a 44 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

Women aged 18-44
Primiparae
Single pregnancy
Spontaneous pregnancy - fisiological pregnancy
pregnancy >= 12 weeks
low-back pain (between the 12th rib and the lumbo-pelvic region) and/or pelvic (in the pubic region and/or in one or both of the sacro-iliac joint and/or of the gluteal region) non specific
consent to treatment
absence of linguistic barriers

Exclusion Criteria:

Women aged <18 o >44
Pathological pregnancy, twins
Metabolic pathologies
Obstetrician's emergencies
Pre-term birth
Specific lumbar and/or pelvic pain - Genetics disorders
Major congenital anomalies
Absence of consent to treatment
Presence of linguistic barriers

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: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: OMT + multidisciplinary path Patients in the experimental group will follow the obstetrician's and multidisciplinary path which provides osteopathic treatments, mindfulness, yoga, clinical nutrition, coaching and usual obstetric care.	Otro: Osteopathic manipulative treatment OMT will be used to treat pregnancy women after having performed a manual osteopathic assessment. The first osteopathic evaluation is carried out during the 12th week, with the possibility to undertake a personalized treatment built on the needs of the single patient; the chosen techniques are based on the collected data by the operator. A "black-box" type of treatment is undertaken. Otro: Mindfulness Mindfulness group weekly meetings. Mindfulness practices consist of cognitive and behavioral treatments for depression and anxiety, including mindfulness-based stress reduction and mindfulness-based cognitive therapy. Otro: Yoga Weekly yoga group meetings. Yoga is a mind-body practice that encompasses a system of postures, deep breathing, and meditation. In this context, yoga practice is adapted to pregnancy with the aim of benefit women who suffer from anxiety, depression, stress, low back pain, and sleep disturbances. Otro: Clinical nutrition Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path. Otro: Coaching There will be five personalized coaching sessions during the pregnancy.
Otro: Usual care Patients in control group will continue the routine obstetrical care as established by international guidelines	Otro: Usual care Administration of routine care based on international guidelines

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: OMT + multidisciplinary path

Patients in the experimental group will follow the obstetrician's and multidisciplinary path which provides osteopathic treatments, mindfulness, yoga, clinical nutrition, coaching and usual obstetric care.

Otro: Osteopathic manipulative treatment

OMT will be used to treat pregnancy women after having performed a manual osteopathic assessment. The first osteopathic evaluation is carried out during the 12th week, with the possibility to undertake a personalized treatment built on the needs of the single patient; the chosen techniques are based on the collected data by the operator. A "black-box" type of treatment is undertaken.

Otro: Mindfulness

Mindfulness group weekly meetings. Mindfulness practices consist of cognitive and behavioral treatments for depression and anxiety, including mindfulness-based stress reduction and mindfulness-based cognitive therapy.

Otro: Yoga

Weekly yoga group meetings. Yoga is a mind-body practice that encompasses a system of postures, deep breathing, and meditation. In this context, yoga practice is adapted to pregnancy with the aim of benefit women who suffer from anxiety, depression, stress, low back pain, and sleep disturbances.

Otro: Clinical nutrition

Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.

Otro: Coaching

There will be five personalized coaching sessions during the pregnancy.

Otro: Usual care

Patients in control group will continue the routine obstetrical care as established by international guidelines

Otro: Usual care

Administration of routine care based on international guidelines

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change in VAS at 6 months Periodo de tiempo: 6 months	Change from Visual Analogue Scale (VAS) of pain at 6 months. VAS values range from 0-10, where 10 means highest pain and 0 no pain	6 months
Change in ODI at 6 months Periodo de tiempo: 6 months	Change from Oswestry disability index 2.1° - Italian version (ODI) of the score at 6 months. The ODI represents a ten 6-point questionnaire. The first section rates the intensity of pain and the remaining ones cover the disabling effect of pain on typical daily activities: personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each item ranges from 0 to 5 and the sum of the 10 scores is expressed as a percentage of the maximum scores, varying from 0 (no disability) to 100 (maximum disability)	6 months
Change in PMI at 6 months Periodo de tiempo: 6 months	Change from Pregnancy mobility index (PMI) of the score at 6 months. PMI is a self-report questionnaire to assess mobility in relation to back and pelvic girdle pain. The PMI consists of three scales: daily mobility in the house, household activities and mobility outdoors. Every item has a score option from 0-3 (respectively 'no problems performing this task', 'some effort performing this task', 'much effort performing this task', 'performing this task is impossible or only possible with the aid of others'), which was transformed to a 0-100 scale. Each domain score is the mean of all included items.	6 months
Change in PGQ at 6 months Periodo de tiempo: 6 months	Change from Pelvic-girdle pain questionnaire (PGQ) of the score at 6 months. The PGQ is a condition-specific, patient-reported outcome measure designed to measure pregnancy-related back pain and pelvic girdle pain for use both during pregnancy and postpartum in research and clinical practice. The questionnaire includes items relating to 2 scales (activity/ participation and body functions [symptoms]). Self-report questionnaire of 20 activity items and 5 symptom items scored on a 4-point response scale. Each question is scored from 'Not at all' (0) to 'To a large extent' (3). Questions on the activity sub-scale range from difficulty with dressing, climbing stairs, doing housework, rolling in bed to pushing a shopping cart. Item scores are summed and transformed to yield a score of 0 to 100, where 100 is the worst possible score.	6 months

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change in PWB at 6 months Periodo de tiempo: 6 months	Change from Ryff's Psychological Well-Being Scales (PWB) of the score at 6 months. Ryff, the 42-item Psychological Wellbeing (PWB) Scale measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate how strongly they agree or disagree with 42 statements using a 7-point scale (1 = strongly agree; 7 = strongly disagree).	6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Come Collaboration

Colaboradores

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigadores

Investigador principal: Niccolò Giovanni, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 (Anticipado)

15 de diciembre de 2020

Finalización primaria (Anticipado)

28 de febrero de 2021

Finalización del estudio (Anticipado)

30 de agosto de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de diciembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

20 de diciembre de 2020

Publicado por primera vez (Actual)

23 de diciembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de diciembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

20 de diciembre de 2020

Última verificación

1 de diciembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

COME-02-20

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

available upon request

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA 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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Low-back Pain During Pregnancy and Its Psycho-social Implications