Low-back Pain During Pregnancy and Its Psycho-social Implications
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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Anticipado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Francesco Cerritelli, PhD
- Número de teléfono: +393394332801
- Correo electrónico: francesco.cerritelli@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Andrea Manzotti, PT
- Número de teléfono: +3902 2052 0939
- Correo electrónico: andreamanzotti@soma-osteopatia.it
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / 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.
|
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.
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.
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.
Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
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
|
Administration of routine care based on international guidelines
|
¿Qué mide el estudio?
Medidas de resultado primarias
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
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
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Niccolò Giovanni, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Inicio del estudio
Finalización primaria (Anticipado)
Finalización primaria
Finalización del estudio (Anticipado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
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
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. .
Ensayos clínicos sobre Lumbalgia
-
NCT04422171ReclutamientoPacientes con EII, tratamiento original, biosimilar, Switch Back
-
NCT01599169TerminadoEficacia y Tolerancia de B-Back® en el Síndrome de Burnout
-
NCT06832202ReclutamientoHER2-LOW Hormonas receptor de cáncer de mama positivo
-
NCT07287917ReclutamientoMelanoma (cáncer de piel) | HER2-LOW Hormonas receptor de cáncer de mama positivo
Ensayos clínicos sobre Osteopathic manipulative treatment
-
NCT07501624Inscripción por invitaciónDe fumar | Dejar de fumar | Trastorno por consumo de tabaco | VIH | SIDA | Farmacia
-
NCT04282655TerminadoAumento de peso | Trastorno de alimentación Neonatal | Lactante de muy bajo peso al nacer